Trial Outcomes & Findings for Adherence Study in COPD Patients (NCT NCT02864342)
NCT ID: NCT02864342
Last Updated: 2018-11-20
Results Overview
The mean number of adherent sets of Symbicort puffs per day for each group, over an average of 26 weeks was calculated. An adherent set of puffs was defined as exactly 2 sets of 2 Symbicort puffs per day. The 2 puffs that constitute a set must have been taken within 60 minutes of each other. A mean of 2.00 sets would be equal to 100% adherence (2 sets of 2 puffs). Subjects who did not take exactly 2 sets of 2 puffs on any given day throughout their device time on study were considered non-adherent for that day.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
138 participants
Primary outcome timeframe
From baseline to end of treatment (EOT), (6 months).
Results posted on
2018-11-20
Participant Flow
Subjects with chronic obstructive pulmonary disease (COPD) were recruited into 8 study sites in the United States from August 2016 to October 2017. The study evaluated the impact of medication reminders on adherence to Symbicort pressurized metered dose inhaler (pMDI) using a BreatheMate bluetooth device that monitored daily Symbicort inhaler use.
Subjects who entered the study already on a stable dose of Symbicort were enrolled and randomized at Visit 1 followed by a 26-week treatment period. Subjects who converted to Symbicort were enrolled at Visit 1 and entered a 25-day run-in period after which they were randomized at Visit 2, followed by a 26-week treatment period.
Participant milestones
| Measure |
Control Group
All subjects took Symbicort pMDI budesonide/formoterol, 160/4.5 micrograms (mcg) x 2 actuations twice daily (BID), for oral inhalation from day 1 (baseline) of the treatment phase.
Subjects randomized to the control group received Symbicort pMDI and a BreatheMate bluetooth monitoring device that monitored daily Symbicort inhaler use, as well as a study-supplied cellular phone that paired with the BreatheMate device to transmit data regarding Symbicort usage. Subjects in the control group did not receive any reminders to take their Symbicort or any feedback regarding medication compliance.
|
Intervention Group
All subjects took Symbicort pMDI, budesonide/formoterol, 160/4.5 mcg x 2 actuations BID, for oral inhalation from day 1 (baseline) of the treatment phase.
Subjects randomized to the intervention group received Symbicort pMDI, a BreatheMate bluetooth monitoring device that monitored daily Symbicort inhaler use, as well as a study-supplied cellular phone that paired with the BreatheMate device to transmit data regarding Symbicort usage. Subjects in the intervention group also received audio-visual daily reminders (beeps and flashes) to take their Symbicort on the BreatheMate Bluetooth monitoring device, and medication reminders from the cellular phone application.
|
|---|---|---|
|
Overall Study
STARTED
|
70
|
68
|
|
Overall Study
Full Analysis Set (FAS)
|
70
|
67
|
|
Overall Study
COMPLETED
|
55
|
49
|
|
Overall Study
NOT COMPLETED
|
15
|
19
|
Reasons for withdrawal
| Measure |
Control Group
All subjects took Symbicort pMDI budesonide/formoterol, 160/4.5 micrograms (mcg) x 2 actuations twice daily (BID), for oral inhalation from day 1 (baseline) of the treatment phase.
Subjects randomized to the control group received Symbicort pMDI and a BreatheMate bluetooth monitoring device that monitored daily Symbicort inhaler use, as well as a study-supplied cellular phone that paired with the BreatheMate device to transmit data regarding Symbicort usage. Subjects in the control group did not receive any reminders to take their Symbicort or any feedback regarding medication compliance.
|
Intervention Group
All subjects took Symbicort pMDI, budesonide/formoterol, 160/4.5 mcg x 2 actuations BID, for oral inhalation from day 1 (baseline) of the treatment phase.
Subjects randomized to the intervention group received Symbicort pMDI, a BreatheMate bluetooth monitoring device that monitored daily Symbicort inhaler use, as well as a study-supplied cellular phone that paired with the BreatheMate device to transmit data regarding Symbicort usage. Subjects in the intervention group also received audio-visual daily reminders (beeps and flashes) to take their Symbicort on the BreatheMate Bluetooth monitoring device, and medication reminders from the cellular phone application.
|
|---|---|---|
|
Overall Study
Eligibility Criteria Deviation
|
2
|
3
|
|
Overall Study
Withdrawal by Subject
|
4
|
2
|
|
Overall Study
Device Technology Issue
|
6
|
7
|
|
Overall Study
Death
|
0
|
1
|
|
Overall Study
Did Not Start Treatment with Symbicort
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
5
|
|
Overall Study
Lost Device
|
1
|
0
|
|
Overall Study
Adverse Event
|
1
|
0
|
Baseline Characteristics
Adherence Study in COPD Patients
Baseline characteristics by cohort
| Measure |
Control Group
n=70 Participants
All subjects took Symbicort pMDI budesonide/formoterol, 160/4.5 micrograms (mcg) x 2 actuations twice daily (BID), for oral inhalation from day 1 (baseline) of the treatment phase.
Subjects randomized to the control group received Symbicort pMDI and a BreatheMate bluetooth monitoring device that monitored daily Symbicort inhaler use, as well as a study-supplied cellular phone that paired with the BreatheMate device to transmit data regarding Symbicort usage. Subjects in the control group did not receive any reminders to take their Symbicort or any feedback regarding medication compliance.
|
Intervention Group
n=67 Participants
All subjects took Symbicort pMDI, budesonide/formoterol, 160/4.5 mcg x 2 actuations BID, for oral inhalation from day 1 (baseline) of the treatment phase.
Subjects randomized to the intervention group received Symbicort pMDI, a BreatheMate bluetooth monitoring device that monitored daily Symbicort inhaler use, as well as a study-supplied cellular phone that paired with the BreatheMate device to transmit data regarding Symbicort usage. Subjects in the intervention group also received audio-visual daily reminders (beeps and flashes) to take their Symbicort on the BreatheMate Bluetooth monitoring device, and medication reminders from the cellular phone application.
|
Total
n=137 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66.6 Years
STANDARD_DEVIATION 8.21 • n=99 Participants
|
66.7 Years
STANDARD_DEVIATION 8.72 • n=107 Participants
|
66.7 Years
STANDARD_DEVIATION 8.43 • n=206 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
60 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
37 Participants
n=99 Participants
|
40 Participants
n=107 Participants
|
77 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
69 Participants
n=99 Participants
|
67 Participants
n=107 Participants
|
136 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
55 Participants
n=99 Participants
|
53 Participants
n=107 Participants
|
108 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: From baseline to end of treatment (EOT), (6 months).Population: The FAS consisted of screened subjects who were randomized and took at least 1 inhalation of Symbicort during the treatment phase of the study.
The mean number of adherent sets of Symbicort puffs per day for each group, over an average of 26 weeks was calculated. An adherent set of puffs was defined as exactly 2 sets of 2 Symbicort puffs per day. The 2 puffs that constitute a set must have been taken within 60 minutes of each other. A mean of 2.00 sets would be equal to 100% adherence (2 sets of 2 puffs). Subjects who did not take exactly 2 sets of 2 puffs on any given day throughout their device time on study were considered non-adherent for that day.
Outcome measures
| Measure |
Control Group
n=70 Participants
All subjects took Symbicort pMDI budesonide/formoterol, 160/4.5 micrograms (mcg) x 2 actuations twice daily (BID), for oral inhalation from day 1 (baseline) of the treatment phase.
Subjects randomized to the control group received Symbicort pMDI and a BreatheMate bluetooth monitoring device that monitored daily Symbicort inhaler use, as well as a study-supplied cellular phone that paired with the BreatheMate device to transmit data regarding Symbicort usage. Subjects in the control group did not receive any reminders to take their Symbicort or any feedback regarding medication compliance.
|
Intervention Group
n=67 Participants
All subjects took Symbicort pMDI, budesonide/formoterol, 160/4.5 mcg x 2 actuations BID, for oral inhalation from day 1 (baseline) of the treatment phase.
Subjects randomized to the intervention group received Symbicort pMDI, a BreatheMate bluetooth monitoring device that monitored daily Symbicort inhaler use, as well as a study-supplied cellular phone that paired with the BreatheMate device to transmit data regarding Symbicort usage. Subjects in the intervention group also received audio-visual daily reminders (beeps and flashes) to take their Symbicort on the BreatheMate Bluetooth monitoring device, and medication reminders from the cellular phone application.
|
|---|---|---|
|
Mean Number of Adherent Sets of Symbicort Puffs Per Day Over the 26-Week Study Period
|
1.3 Adherent sets of puffs / day
Standard Deviation 0.51
|
1.6 Adherent sets of puffs / day
Standard Deviation 0.39
|
SECONDARY outcome
Timeframe: From baseline to EOT (6 months).Population: The FAS consisted of screened subjects who were randomized and took at least 1 inhalation of Symbicort during the treatment phase of the study. Only subjects with CCQ results available for analysis are presented.
The CCQ is a 10-item measure of a subject's COPD symptoms, divided into 3 domains (Symptoms: Items 1, 2, 5 and 6; Functional State: Items 7, 8, 9, and 10; and Mental State: Items 3 and 4). Individual items within the CCQ were equally weighted. The total score was calculated by adding the scores of the 10 items and dividing that number by 10 (=number of items). In addition, individual domain scores were calculated. The total CCQ score and each of the 3 domain scores range from 0 (very good health status) to 6 (extremely poor health status). CCQ data was collected for all subjects at baseline and EOT visits. The mean CCQ total and domain scores at both baseline and 26 weeks (EOT) are presented along with the mean change from baseline at EOT or week 26. A positive change indicates worsening symptoms and a higher value is indicative of a poorer health status.
Outcome measures
| Measure |
Control Group
n=70 Participants
All subjects took Symbicort pMDI budesonide/formoterol, 160/4.5 micrograms (mcg) x 2 actuations twice daily (BID), for oral inhalation from day 1 (baseline) of the treatment phase.
Subjects randomized to the control group received Symbicort pMDI and a BreatheMate bluetooth monitoring device that monitored daily Symbicort inhaler use, as well as a study-supplied cellular phone that paired with the BreatheMate device to transmit data regarding Symbicort usage. Subjects in the control group did not receive any reminders to take their Symbicort or any feedback regarding medication compliance.
|
Intervention Group
n=67 Participants
All subjects took Symbicort pMDI, budesonide/formoterol, 160/4.5 mcg x 2 actuations BID, for oral inhalation from day 1 (baseline) of the treatment phase.
Subjects randomized to the intervention group received Symbicort pMDI, a BreatheMate bluetooth monitoring device that monitored daily Symbicort inhaler use, as well as a study-supplied cellular phone that paired with the BreatheMate device to transmit data regarding Symbicort usage. Subjects in the intervention group also received audio-visual daily reminders (beeps and flashes) to take their Symbicort on the BreatheMate Bluetooth monitoring device, and medication reminders from the cellular phone application.
|
|---|---|---|
|
Mean Clinical COPD Questionnaire (CCQ) Scores at Baseline, EOT, and Mean Change in Score Over the 26-Week Study Period.
CCQ Total Score: Baseline
|
2.7 Units on the CCQ scale
Standard Deviation 0.97
|
2.2 Units on the CCQ scale
Standard Deviation 0.83
|
|
Mean Clinical COPD Questionnaire (CCQ) Scores at Baseline, EOT, and Mean Change in Score Over the 26-Week Study Period.
CCQ Total Score: EOT
|
2.6 Units on the CCQ scale
Standard Deviation 1.08
|
2.4 Units on the CCQ scale
Standard Deviation 1.18
|
|
Mean Clinical COPD Questionnaire (CCQ) Scores at Baseline, EOT, and Mean Change in Score Over the 26-Week Study Period.
CCQ Total Score: Change from baseline
|
-0.2 Units on the CCQ scale
Standard Deviation 0.99
|
0.2 Units on the CCQ scale
Standard Deviation 0.97
|
|
Mean Clinical COPD Questionnaire (CCQ) Scores at Baseline, EOT, and Mean Change in Score Over the 26-Week Study Period.
Symptom Score: Baseline
|
2.9 Units on the CCQ scale
Standard Deviation 1.07
|
2.4 Units on the CCQ scale
Standard Deviation 1.08
|
|
Mean Clinical COPD Questionnaire (CCQ) Scores at Baseline, EOT, and Mean Change in Score Over the 26-Week Study Period.
Symptom Score: EOT
|
2.7 Units on the CCQ scale
Standard Deviation 1.11
|
2.4 Units on the CCQ scale
Standard Deviation 1.13
|
|
Mean Clinical COPD Questionnaire (CCQ) Scores at Baseline, EOT, and Mean Change in Score Over the 26-Week Study Period.
Symptom Score: Change from baseline
|
-0.3 Units on the CCQ scale
Standard Deviation 1.13
|
0.0 Units on the CCQ scale
Standard Deviation 1.16
|
|
Mean Clinical COPD Questionnaire (CCQ) Scores at Baseline, EOT, and Mean Change in Score Over the 26-Week Study Period.
Functional State Score: Baseline
|
2.7 Units on the CCQ scale
Standard Deviation 1.39
|
2.2 Units on the CCQ scale
Standard Deviation 0.91
|
|
Mean Clinical COPD Questionnaire (CCQ) Scores at Baseline, EOT, and Mean Change in Score Over the 26-Week Study Period.
Functional State Score: EOT
|
2.7 Units on the CCQ scale
Standard Deviation 1.36
|
2.6 Units on the CCQ scale
Standard Deviation 1.30
|
|
Mean Clinical COPD Questionnaire (CCQ) Scores at Baseline, EOT, and Mean Change in Score Over the 26-Week Study Period.
Functional State Score: Change from baseline
|
0.0 Units on the CCQ scale
Standard Deviation 1.32
|
0.4 Units on the CCQ scale
Standard Deviation 1.22
|
|
Mean Clinical COPD Questionnaire (CCQ) Scores at Baseline, EOT, and Mean Change in Score Over the 26-Week Study Period.
Mental State Score: Baseline
|
2.3 Units on the CCQ scale
Standard Deviation 1.37
|
1.6 Units on the CCQ scale
Standard Deviation 1.15
|
|
Mean Clinical COPD Questionnaire (CCQ) Scores at Baseline, EOT, and Mean Change in Score Over the 26-Week Study Period.
Mental State Score: EOT
|
2.0 Units on the CCQ scale
Standard Deviation 1.42
|
1.7 Units on the CCQ scale
Standard Deviation 1.63
|
|
Mean Clinical COPD Questionnaire (CCQ) Scores at Baseline, EOT, and Mean Change in Score Over the 26-Week Study Period.
Mental State Score: Change from baseline
|
-0.4 Units on the CCQ scale
Standard Deviation 1.50
|
0.2 Units on the CCQ scale
Standard Deviation 1.38
|
SECONDARY outcome
Timeframe: From baseline to EOT (6 months).Population: The FAS consisted of screened subjects who were randomized and took at least 1 inhalation of Symbicort during the treatment phase of the study. Only subjects with CCQ results available for analysis are presented.
The CCQ is a 10-item measure of a subject's COPD symptoms, divided into 3 domains (Symptoms: Items 1, 2, 5 and 6; Functional State: Items 7, 8, 9, and 10; and Mental State: Items 3 and 4). Individual items within the CCQ were equally weighted. The total score was calculated by adding the scores of the 10 items and dividing that number by 10 (=number of items). Individual domain scores were also calculated. The total CCQ score and each of the 3 domain scores range from 0 (very good health status) to 6 (extremely poor health status). Subjects in the intervention group took the CCQ weekly throughout the study. The 26-week treatment period was broken down into 3, 2-month intervals: Interval 1: from study day 1 to study day 63 (inclusive), Interval 2: study day 64 to study day 126 (inclusive), Interval 3: study day 127 to EOT (inclusive). The last week of each 2-month interval was used to represent that interval and results are presented for the total CCQ score and the 3 domain scores.
Outcome measures
| Measure |
Control Group
n=67 Participants
All subjects took Symbicort pMDI budesonide/formoterol, 160/4.5 micrograms (mcg) x 2 actuations twice daily (BID), for oral inhalation from day 1 (baseline) of the treatment phase.
Subjects randomized to the control group received Symbicort pMDI and a BreatheMate bluetooth monitoring device that monitored daily Symbicort inhaler use, as well as a study-supplied cellular phone that paired with the BreatheMate device to transmit data regarding Symbicort usage. Subjects in the control group did not receive any reminders to take their Symbicort or any feedback regarding medication compliance.
|
Intervention Group
All subjects took Symbicort pMDI, budesonide/formoterol, 160/4.5 mcg x 2 actuations BID, for oral inhalation from day 1 (baseline) of the treatment phase.
Subjects randomized to the intervention group received Symbicort pMDI, a BreatheMate bluetooth monitoring device that monitored daily Symbicort inhaler use, as well as a study-supplied cellular phone that paired with the BreatheMate device to transmit data regarding Symbicort usage. Subjects in the intervention group also received audio-visual daily reminders (beeps and flashes) to take their Symbicort on the BreatheMate Bluetooth monitoring device, and medication reminders from the cellular phone application.
|
|---|---|---|
|
Mean Total and Domain Weekly CCQ Scores Over Each 2-Month Study Interval for the Intervention Group.
CCQ Total Score: Interval 2, Week 18
|
2.3 Units on the CCQ scale.
Standard Deviation 1.07
|
—
|
|
Mean Total and Domain Weekly CCQ Scores Over Each 2-Month Study Interval for the Intervention Group.
CCQ Total Score: Interval 1, Week 9
|
2.2 Units on the CCQ scale.
Standard Deviation 1.06
|
—
|
|
Mean Total and Domain Weekly CCQ Scores Over Each 2-Month Study Interval for the Intervention Group.
CCQ Total Score: Interval 3, Week 27
|
2.0 Units on the CCQ scale.
Standard Deviation 0.14
|
—
|
|
Mean Total and Domain Weekly CCQ Scores Over Each 2-Month Study Interval for the Intervention Group.
CCQ Symptom Score: Interval 1, Week 9
|
2.4 Units on the CCQ scale.
Standard Deviation 1.24
|
—
|
|
Mean Total and Domain Weekly CCQ Scores Over Each 2-Month Study Interval for the Intervention Group.
CCQ Symptom Score: Interval 2, Week 18
|
2.6 Units on the CCQ scale.
Standard Deviation 1.26
|
—
|
|
Mean Total and Domain Weekly CCQ Scores Over Each 2-Month Study Interval for the Intervention Group.
CCQ Symptom Score: Interval 3, Week 27
|
2.2 Units on the CCQ scale.
Standard Deviation 0.23
|
—
|
|
Mean Total and Domain Weekly CCQ Scores Over Each 2-Month Study Interval for the Intervention Group.
CCQ Functional State Score: Interval 1, Week 9
|
2.1 Units on the CCQ scale.
Standard Deviation 1.09
|
—
|
|
Mean Total and Domain Weekly CCQ Scores Over Each 2-Month Study Interval for the Intervention Group.
CCQ Functional State Score: Interval 2, Week 18
|
2.3 Units on the CCQ scale.
Standard Deviation 1.09
|
—
|
|
Mean Total and Domain Weekly CCQ Scores Over Each 2-Month Study Interval for the Intervention Group.
CCQ Functional State Score: Interval 3, Week 27
|
2.3 Units on the CCQ scale.
Standard Deviation 0.47
|
—
|
|
Mean Total and Domain Weekly CCQ Scores Over Each 2-Month Study Interval for the Intervention Group.
CCQ Mental State Score: Interval 1, Week 9
|
1.9 Units on the CCQ scale.
Standard Deviation 1.25
|
—
|
|
Mean Total and Domain Weekly CCQ Scores Over Each 2-Month Study Interval for the Intervention Group.
CCQ Mental State Score: Interval 2, Week 18
|
1.9 Units on the CCQ scale.
Standard Deviation 1.28
|
—
|
|
Mean Total and Domain Weekly CCQ Scores Over Each 2-Month Study Interval for the Intervention Group.
CCQ Mental State Score: Interval 3, Week 27
|
1.0 Units on the CCQ scale.
Standard Deviation 0.71
|
—
|
SECONDARY outcome
Timeframe: From baseline to EOT (6 months).Population: The FAS consisted of screened subjects who were randomized and took at least 1 inhalation of Symbicort during the treatment phase of the study. Only subjects with data available for analysis are presented.
The mean number of adherent sets of Symbicort puffs per day was calculated for each subject, for each of the 3, 2-month study intervals. Interval 1: from study day 1 to study day 63 (inclusive); Interval 2: study day 64 to study day 126 (inclusive); Interval 3: study day 127 to EOT (inclusive). A set is 2 puffs taken on the same calendar day, with the 2 puffs taken within 60 minutes of each other. The mean number of sets of Symbicort puffs per day was determined only for the days during device time on study for each subject.
Outcome measures
| Measure |
Control Group
n=70 Participants
All subjects took Symbicort pMDI budesonide/formoterol, 160/4.5 micrograms (mcg) x 2 actuations twice daily (BID), for oral inhalation from day 1 (baseline) of the treatment phase.
Subjects randomized to the control group received Symbicort pMDI and a BreatheMate bluetooth monitoring device that monitored daily Symbicort inhaler use, as well as a study-supplied cellular phone that paired with the BreatheMate device to transmit data regarding Symbicort usage. Subjects in the control group did not receive any reminders to take their Symbicort or any feedback regarding medication compliance.
|
Intervention Group
n=67 Participants
All subjects took Symbicort pMDI, budesonide/formoterol, 160/4.5 mcg x 2 actuations BID, for oral inhalation from day 1 (baseline) of the treatment phase.
Subjects randomized to the intervention group received Symbicort pMDI, a BreatheMate bluetooth monitoring device that monitored daily Symbicort inhaler use, as well as a study-supplied cellular phone that paired with the BreatheMate device to transmit data regarding Symbicort usage. Subjects in the intervention group also received audio-visual daily reminders (beeps and flashes) to take their Symbicort on the BreatheMate Bluetooth monitoring device, and medication reminders from the cellular phone application.
|
|---|---|---|
|
Mean Number of Adherent Sets of Puffs Per Day for Each 2-Month Study Interval.
Interval 1
|
1.4 Adherent sets of puffs / day
Standard Deviation 0.51
|
1.6 Adherent sets of puffs / day
Standard Deviation 0.37
|
|
Mean Number of Adherent Sets of Puffs Per Day for Each 2-Month Study Interval.
Interval 2
|
1.2 Adherent sets of puffs / day
Standard Deviation 0.61
|
1.6 Adherent sets of puffs / day
Standard Deviation 0.48
|
|
Mean Number of Adherent Sets of Puffs Per Day for Each 2-Month Study Interval.
Interval 3
|
1.2 Adherent sets of puffs / day
Standard Deviation 0.61
|
1.6 Adherent sets of puffs / day
Standard Deviation 0.51
|
SECONDARY outcome
Timeframe: From baseline to EOT (6 months).Population: The FAS consists of screened subjects who were randomized and took at least 1 inhalation of Symbicort during the treatment phase of the study.
The total number of adherent days was defined as the number of treatment days a subject took 2 sets of 2 puffs of Symbicort and the inhalations in a puff set were within 60 minutes of each other. Subjects who did not take exactly 2 sets of 2 puffs on any given day throughout their device time on study were considered non-adherent for that day. The total number of adherent days for each subject was counted over the 26 week treatment period and the mean number of adherent days per group is presented.
Outcome measures
| Measure |
Control Group
n=70 Participants
All subjects took Symbicort pMDI budesonide/formoterol, 160/4.5 micrograms (mcg) x 2 actuations twice daily (BID), for oral inhalation from day 1 (baseline) of the treatment phase.
Subjects randomized to the control group received Symbicort pMDI and a BreatheMate bluetooth monitoring device that monitored daily Symbicort inhaler use, as well as a study-supplied cellular phone that paired with the BreatheMate device to transmit data regarding Symbicort usage. Subjects in the control group did not receive any reminders to take their Symbicort or any feedback regarding medication compliance.
|
Intervention Group
n=67 Participants
All subjects took Symbicort pMDI, budesonide/formoterol, 160/4.5 mcg x 2 actuations BID, for oral inhalation from day 1 (baseline) of the treatment phase.
Subjects randomized to the intervention group received Symbicort pMDI, a BreatheMate bluetooth monitoring device that monitored daily Symbicort inhaler use, as well as a study-supplied cellular phone that paired with the BreatheMate device to transmit data regarding Symbicort usage. Subjects in the intervention group also received audio-visual daily reminders (beeps and flashes) to take their Symbicort on the BreatheMate Bluetooth monitoring device, and medication reminders from the cellular phone application.
|
|---|---|---|
|
Mean Number of Adherent Days Over the 26-Week Study Period.
|
102.3 Days
Standard Deviation 50.76
|
128.4 Days
Standard Deviation 50.75
|
SECONDARY outcome
Timeframe: From baseline to EOT (6 months).Population: The FAS consisted of screened subjects who were randomized and took at least 1 inhalation of Symbicort during the treatment phase of the study. Only subjects with data available for analysis are presented.
The total number of Symbicort prescriptions filled at a pharmacy during the 26-week treatment period was counted per subject. The mean number of Symbicort 30-day prescription refills per subject was then calculated and presented per group.
Outcome measures
| Measure |
Control Group
n=70 Participants
All subjects took Symbicort pMDI budesonide/formoterol, 160/4.5 micrograms (mcg) x 2 actuations twice daily (BID), for oral inhalation from day 1 (baseline) of the treatment phase.
Subjects randomized to the control group received Symbicort pMDI and a BreatheMate bluetooth monitoring device that monitored daily Symbicort inhaler use, as well as a study-supplied cellular phone that paired with the BreatheMate device to transmit data regarding Symbicort usage. Subjects in the control group did not receive any reminders to take their Symbicort or any feedback regarding medication compliance.
|
Intervention Group
n=67 Participants
All subjects took Symbicort pMDI, budesonide/formoterol, 160/4.5 mcg x 2 actuations BID, for oral inhalation from day 1 (baseline) of the treatment phase.
Subjects randomized to the intervention group received Symbicort pMDI, a BreatheMate bluetooth monitoring device that monitored daily Symbicort inhaler use, as well as a study-supplied cellular phone that paired with the BreatheMate device to transmit data regarding Symbicort usage. Subjects in the intervention group also received audio-visual daily reminders (beeps and flashes) to take their Symbicort on the BreatheMate Bluetooth monitoring device, and medication reminders from the cellular phone application.
|
|---|---|---|
|
Mean Number of Symbicort Prescription Refills at Pharmacy Over the 26-Week Study Period.
|
5.1 Number of Refills
Standard Deviation 1.36
|
5.3 Number of Refills
Standard Deviation 1.29
|
Adverse Events
CONTROL GROUP
Serious events: 5 serious events
Other events: 18 other events
Deaths: 0 deaths
INTERVENTION GROUP
Serious events: 8 serious events
Other events: 15 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
CONTROL GROUP
n=70 participants at risk
All subjects took Symbicort pMDI budesonide/formoterol, 160/4.5 mcg x 2 actuations BID, for oral inhalation from day 1 (baseline) of the treatment phase.
Subjects randomized to the control group received Symbicort pMDI and a BreatheMate bluetooth monitoring device that monitored daily Symbicort inhaler use, as well as a study-supplied cellular phone that paired with the BreatheMate device to transmit data regarding Symbicort usage. Subjects in the control group did not receive any reminders to take their Symbicort or any feedback regarding medication compliance.
|
INTERVENTION GROUP
n=67 participants at risk
All subjects took Symbicort pMDI, budesonide/formoterol, 160/4.5 mcg x 2 actuations BID, for oral inhalation from day 1 (baseline) of the treatment phase. Subjects randomized to the intervention group received Symbicort pMDI, a BreatheMate bluetooth monitoring device that monitored daily Symbicort inhaler use, as well as a study-supplied cellular phone that paired with the BreatheMate device to transmit data regarding Symbicort usage. Subjects in the intervention group also received audio-visual daily reminders (beeps and flashes) to take their Symbicort on the BreatheMate Bluetooth monitoring device, and medication reminders from the cellular phone application.
|
|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/70 • Adverse events were assessed at the informed consent visit (Visit 1), at study day 90 and at the last follow-up telephone contact 30-days after the EOT visit on day 180 (approximately 7 months).
|
1.5%
1/67 • Number of events 1 • Adverse events were assessed at the informed consent visit (Visit 1), at study day 90 and at the last follow-up telephone contact 30-days after the EOT visit on day 180 (approximately 7 months).
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/70 • Adverse events were assessed at the informed consent visit (Visit 1), at study day 90 and at the last follow-up telephone contact 30-days after the EOT visit on day 180 (approximately 7 months).
|
1.5%
1/67 • Number of events 1 • Adverse events were assessed at the informed consent visit (Visit 1), at study day 90 and at the last follow-up telephone contact 30-days after the EOT visit on day 180 (approximately 7 months).
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/70 • Adverse events were assessed at the informed consent visit (Visit 1), at study day 90 and at the last follow-up telephone contact 30-days after the EOT visit on day 180 (approximately 7 months).
|
1.5%
1/67 • Number of events 1 • Adverse events were assessed at the informed consent visit (Visit 1), at study day 90 and at the last follow-up telephone contact 30-days after the EOT visit on day 180 (approximately 7 months).
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/70 • Adverse events were assessed at the informed consent visit (Visit 1), at study day 90 and at the last follow-up telephone contact 30-days after the EOT visit on day 180 (approximately 7 months).
|
1.5%
1/67 • Number of events 1 • Adverse events were assessed at the informed consent visit (Visit 1), at study day 90 and at the last follow-up telephone contact 30-days after the EOT visit on day 180 (approximately 7 months).
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/70 • Adverse events were assessed at the informed consent visit (Visit 1), at study day 90 and at the last follow-up telephone contact 30-days after the EOT visit on day 180 (approximately 7 months).
|
1.5%
1/67 • Number of events 1 • Adverse events were assessed at the informed consent visit (Visit 1), at study day 90 and at the last follow-up telephone contact 30-days after the EOT visit on day 180 (approximately 7 months).
|
|
Gastrointestinal disorders
Inguinal hernia
|
1.4%
1/70 • Number of events 1 • Adverse events were assessed at the informed consent visit (Visit 1), at study day 90 and at the last follow-up telephone contact 30-days after the EOT visit on day 180 (approximately 7 months).
|
0.00%
0/67 • Adverse events were assessed at the informed consent visit (Visit 1), at study day 90 and at the last follow-up telephone contact 30-days after the EOT visit on day 180 (approximately 7 months).
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
1.4%
1/70 • Number of events 1 • Adverse events were assessed at the informed consent visit (Visit 1), at study day 90 and at the last follow-up telephone contact 30-days after the EOT visit on day 180 (approximately 7 months).
|
0.00%
0/67 • Adverse events were assessed at the informed consent visit (Visit 1), at study day 90 and at the last follow-up telephone contact 30-days after the EOT visit on day 180 (approximately 7 months).
|
|
Hepatobiliary disorders
Cholecystitis
|
1.4%
1/70 • Number of events 1 • Adverse events were assessed at the informed consent visit (Visit 1), at study day 90 and at the last follow-up telephone contact 30-days after the EOT visit on day 180 (approximately 7 months).
|
0.00%
0/67 • Adverse events were assessed at the informed consent visit (Visit 1), at study day 90 and at the last follow-up telephone contact 30-days after the EOT visit on day 180 (approximately 7 months).
|
|
Infections and infestations
Bacteraemia
|
1.4%
1/70 • Number of events 1 • Adverse events were assessed at the informed consent visit (Visit 1), at study day 90 and at the last follow-up telephone contact 30-days after the EOT visit on day 180 (approximately 7 months).
|
0.00%
0/67 • Adverse events were assessed at the informed consent visit (Visit 1), at study day 90 and at the last follow-up telephone contact 30-days after the EOT visit on day 180 (approximately 7 months).
|
|
Infections and infestations
Influenza
|
0.00%
0/70 • Adverse events were assessed at the informed consent visit (Visit 1), at study day 90 and at the last follow-up telephone contact 30-days after the EOT visit on day 180 (approximately 7 months).
|
3.0%
2/67 • Number of events 2 • Adverse events were assessed at the informed consent visit (Visit 1), at study day 90 and at the last follow-up telephone contact 30-days after the EOT visit on day 180 (approximately 7 months).
|
|
Infections and infestations
Pneumonia
|
1.4%
1/70 • Number of events 2 • Adverse events were assessed at the informed consent visit (Visit 1), at study day 90 and at the last follow-up telephone contact 30-days after the EOT visit on day 180 (approximately 7 months).
|
1.5%
1/67 • Number of events 1 • Adverse events were assessed at the informed consent visit (Visit 1), at study day 90 and at the last follow-up telephone contact 30-days after the EOT visit on day 180 (approximately 7 months).
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
1.4%
1/70 • Number of events 1 • Adverse events were assessed at the informed consent visit (Visit 1), at study day 90 and at the last follow-up telephone contact 30-days after the EOT visit on day 180 (approximately 7 months).
|
0.00%
0/67 • Adverse events were assessed at the informed consent visit (Visit 1), at study day 90 and at the last follow-up telephone contact 30-days after the EOT visit on day 180 (approximately 7 months).
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
1.4%
1/70 • Number of events 1 • Adverse events were assessed at the informed consent visit (Visit 1), at study day 90 and at the last follow-up telephone contact 30-days after the EOT visit on day 180 (approximately 7 months).
|
3.0%
2/67 • Number of events 2 • Adverse events were assessed at the informed consent visit (Visit 1), at study day 90 and at the last follow-up telephone contact 30-days after the EOT visit on day 180 (approximately 7 months).
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
4.3%
3/70 • Number of events 4 • Adverse events were assessed at the informed consent visit (Visit 1), at study day 90 and at the last follow-up telephone contact 30-days after the EOT visit on day 180 (approximately 7 months).
|
4.5%
3/67 • Number of events 3 • Adverse events were assessed at the informed consent visit (Visit 1), at study day 90 and at the last follow-up telephone contact 30-days after the EOT visit on day 180 (approximately 7 months).
|
|
Vascular disorders
Hypertension
|
0.00%
0/70 • Adverse events were assessed at the informed consent visit (Visit 1), at study day 90 and at the last follow-up telephone contact 30-days after the EOT visit on day 180 (approximately 7 months).
|
1.5%
1/67 • Number of events 1 • Adverse events were assessed at the informed consent visit (Visit 1), at study day 90 and at the last follow-up telephone contact 30-days after the EOT visit on day 180 (approximately 7 months).
|
Other adverse events
| Measure |
CONTROL GROUP
n=70 participants at risk
All subjects took Symbicort pMDI budesonide/formoterol, 160/4.5 mcg x 2 actuations BID, for oral inhalation from day 1 (baseline) of the treatment phase.
Subjects randomized to the control group received Symbicort pMDI and a BreatheMate bluetooth monitoring device that monitored daily Symbicort inhaler use, as well as a study-supplied cellular phone that paired with the BreatheMate device to transmit data regarding Symbicort usage. Subjects in the control group did not receive any reminders to take their Symbicort or any feedback regarding medication compliance.
|
INTERVENTION GROUP
n=67 participants at risk
All subjects took Symbicort pMDI, budesonide/formoterol, 160/4.5 mcg x 2 actuations BID, for oral inhalation from day 1 (baseline) of the treatment phase. Subjects randomized to the intervention group received Symbicort pMDI, a BreatheMate bluetooth monitoring device that monitored daily Symbicort inhaler use, as well as a study-supplied cellular phone that paired with the BreatheMate device to transmit data regarding Symbicort usage. Subjects in the intervention group also received audio-visual daily reminders (beeps and flashes) to take their Symbicort on the BreatheMate Bluetooth monitoring device, and medication reminders from the cellular phone application.
|
|---|---|---|
|
Cardiac disorders
Supraventricular extrasystoles
|
1.4%
1/70 • Number of events 1 • Adverse events were assessed at the informed consent visit (Visit 1), at study day 90 and at the last follow-up telephone contact 30-days after the EOT visit on day 180 (approximately 7 months).
|
0.00%
0/67 • Adverse events were assessed at the informed consent visit (Visit 1), at study day 90 and at the last follow-up telephone contact 30-days after the EOT visit on day 180 (approximately 7 months).
|
|
Eye disorders
Cataract
|
2.9%
2/70 • Number of events 3 • Adverse events were assessed at the informed consent visit (Visit 1), at study day 90 and at the last follow-up telephone contact 30-days after the EOT visit on day 180 (approximately 7 months).
|
0.00%
0/67 • Adverse events were assessed at the informed consent visit (Visit 1), at study day 90 and at the last follow-up telephone contact 30-days after the EOT visit on day 180 (approximately 7 months).
|
|
Eye disorders
Trichiasis
|
1.4%
1/70 • Number of events 1 • Adverse events were assessed at the informed consent visit (Visit 1), at study day 90 and at the last follow-up telephone contact 30-days after the EOT visit on day 180 (approximately 7 months).
|
0.00%
0/67 • Adverse events were assessed at the informed consent visit (Visit 1), at study day 90 and at the last follow-up telephone contact 30-days after the EOT visit on day 180 (approximately 7 months).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/70 • Adverse events were assessed at the informed consent visit (Visit 1), at study day 90 and at the last follow-up telephone contact 30-days after the EOT visit on day 180 (approximately 7 months).
|
1.5%
1/67 • Number of events 1 • Adverse events were assessed at the informed consent visit (Visit 1), at study day 90 and at the last follow-up telephone contact 30-days after the EOT visit on day 180 (approximately 7 months).
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/70 • Adverse events were assessed at the informed consent visit (Visit 1), at study day 90 and at the last follow-up telephone contact 30-days after the EOT visit on day 180 (approximately 7 months).
|
1.5%
1/67 • Number of events 1 • Adverse events were assessed at the informed consent visit (Visit 1), at study day 90 and at the last follow-up telephone contact 30-days after the EOT visit on day 180 (approximately 7 months).
|
|
Gastrointestinal disorders
Gastritis
|
1.4%
1/70 • Number of events 1 • Adverse events were assessed at the informed consent visit (Visit 1), at study day 90 and at the last follow-up telephone contact 30-days after the EOT visit on day 180 (approximately 7 months).
|
0.00%
0/67 • Adverse events were assessed at the informed consent visit (Visit 1), at study day 90 and at the last follow-up telephone contact 30-days after the EOT visit on day 180 (approximately 7 months).
|
|
Gastrointestinal disorders
Haematochezia
|
1.4%
1/70 • Number of events 1 • Adverse events were assessed at the informed consent visit (Visit 1), at study day 90 and at the last follow-up telephone contact 30-days after the EOT visit on day 180 (approximately 7 months).
|
0.00%
0/67 • Adverse events were assessed at the informed consent visit (Visit 1), at study day 90 and at the last follow-up telephone contact 30-days after the EOT visit on day 180 (approximately 7 months).
|
|
Gastrointestinal disorders
Hiatus hernia
|
1.4%
1/70 • Number of events 1 • Adverse events were assessed at the informed consent visit (Visit 1), at study day 90 and at the last follow-up telephone contact 30-days after the EOT visit on day 180 (approximately 7 months).
|
0.00%
0/67 • Adverse events were assessed at the informed consent visit (Visit 1), at study day 90 and at the last follow-up telephone contact 30-days after the EOT visit on day 180 (approximately 7 months).
|
|
Gastrointestinal disorders
Melaena
|
1.4%
1/70 • Number of events 1 • Adverse events were assessed at the informed consent visit (Visit 1), at study day 90 and at the last follow-up telephone contact 30-days after the EOT visit on day 180 (approximately 7 months).
|
0.00%
0/67 • Adverse events were assessed at the informed consent visit (Visit 1), at study day 90 and at the last follow-up telephone contact 30-days after the EOT visit on day 180 (approximately 7 months).
|
|
General disorders
Fatigue
|
0.00%
0/70 • Adverse events were assessed at the informed consent visit (Visit 1), at study day 90 and at the last follow-up telephone contact 30-days after the EOT visit on day 180 (approximately 7 months).
|
1.5%
1/67 • Number of events 1 • Adverse events were assessed at the informed consent visit (Visit 1), at study day 90 and at the last follow-up telephone contact 30-days after the EOT visit on day 180 (approximately 7 months).
|
|
General disorders
Oedema peripheral
|
1.4%
1/70 • Number of events 1 • Adverse events were assessed at the informed consent visit (Visit 1), at study day 90 and at the last follow-up telephone contact 30-days after the EOT visit on day 180 (approximately 7 months).
|
1.5%
1/67 • Number of events 1 • Adverse events were assessed at the informed consent visit (Visit 1), at study day 90 and at the last follow-up telephone contact 30-days after the EOT visit on day 180 (approximately 7 months).
|
|
General disorders
Peripheral swelling
|
1.4%
1/70 • Number of events 2 • Adverse events were assessed at the informed consent visit (Visit 1), at study day 90 and at the last follow-up telephone contact 30-days after the EOT visit on day 180 (approximately 7 months).
|
0.00%
0/67 • Adverse events were assessed at the informed consent visit (Visit 1), at study day 90 and at the last follow-up telephone contact 30-days after the EOT visit on day 180 (approximately 7 months).
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/70 • Adverse events were assessed at the informed consent visit (Visit 1), at study day 90 and at the last follow-up telephone contact 30-days after the EOT visit on day 180 (approximately 7 months).
|
1.5%
1/67 • Number of events 1 • Adverse events were assessed at the informed consent visit (Visit 1), at study day 90 and at the last follow-up telephone contact 30-days after the EOT visit on day 180 (approximately 7 months).
|
|
Infections and infestations
Acute sinusitis
|
1.4%
1/70 • Number of events 1 • Adverse events were assessed at the informed consent visit (Visit 1), at study day 90 and at the last follow-up telephone contact 30-days after the EOT visit on day 180 (approximately 7 months).
|
1.5%
1/67 • Number of events 2 • Adverse events were assessed at the informed consent visit (Visit 1), at study day 90 and at the last follow-up telephone contact 30-days after the EOT visit on day 180 (approximately 7 months).
|
|
Infections and infestations
Eye infection
|
0.00%
0/70 • Adverse events were assessed at the informed consent visit (Visit 1), at study day 90 and at the last follow-up telephone contact 30-days after the EOT visit on day 180 (approximately 7 months).
|
1.5%
1/67 • Number of events 1 • Adverse events were assessed at the informed consent visit (Visit 1), at study day 90 and at the last follow-up telephone contact 30-days after the EOT visit on day 180 (approximately 7 months).
|
|
Infections and infestations
Nasopharyngitis
|
1.4%
1/70 • Number of events 1 • Adverse events were assessed at the informed consent visit (Visit 1), at study day 90 and at the last follow-up telephone contact 30-days after the EOT visit on day 180 (approximately 7 months).
|
1.5%
1/67 • Number of events 1 • Adverse events were assessed at the informed consent visit (Visit 1), at study day 90 and at the last follow-up telephone contact 30-days after the EOT visit on day 180 (approximately 7 months).
|
|
Infections and infestations
Oral candidiasis
|
2.9%
2/70 • Number of events 2 • Adverse events were assessed at the informed consent visit (Visit 1), at study day 90 and at the last follow-up telephone contact 30-days after the EOT visit on day 180 (approximately 7 months).
|
0.00%
0/67 • Adverse events were assessed at the informed consent visit (Visit 1), at study day 90 and at the last follow-up telephone contact 30-days after the EOT visit on day 180 (approximately 7 months).
|
|
Infections and infestations
Pyelonephritis acute
|
1.4%
1/70 • Number of events 1 • Adverse events were assessed at the informed consent visit (Visit 1), at study day 90 and at the last follow-up telephone contact 30-days after the EOT visit on day 180 (approximately 7 months).
|
0.00%
0/67 • Adverse events were assessed at the informed consent visit (Visit 1), at study day 90 and at the last follow-up telephone contact 30-days after the EOT visit on day 180 (approximately 7 months).
|
|
Injury, poisoning and procedural complications
Fall
|
1.4%
1/70 • Number of events 1 • Adverse events were assessed at the informed consent visit (Visit 1), at study day 90 and at the last follow-up telephone contact 30-days after the EOT visit on day 180 (approximately 7 months).
|
0.00%
0/67 • Adverse events were assessed at the informed consent visit (Visit 1), at study day 90 and at the last follow-up telephone contact 30-days after the EOT visit on day 180 (approximately 7 months).
|
|
Injury, poisoning and procedural complications
Laceration
|
1.4%
1/70 • Number of events 1 • Adverse events were assessed at the informed consent visit (Visit 1), at study day 90 and at the last follow-up telephone contact 30-days after the EOT visit on day 180 (approximately 7 months).
|
0.00%
0/67 • Adverse events were assessed at the informed consent visit (Visit 1), at study day 90 and at the last follow-up telephone contact 30-days after the EOT visit on day 180 (approximately 7 months).
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/70 • Adverse events were assessed at the informed consent visit (Visit 1), at study day 90 and at the last follow-up telephone contact 30-days after the EOT visit on day 180 (approximately 7 months).
|
1.5%
1/67 • Number of events 1 • Adverse events were assessed at the informed consent visit (Visit 1), at study day 90 and at the last follow-up telephone contact 30-days after the EOT visit on day 180 (approximately 7 months).
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/70 • Adverse events were assessed at the informed consent visit (Visit 1), at study day 90 and at the last follow-up telephone contact 30-days after the EOT visit on day 180 (approximately 7 months).
|
1.5%
1/67 • Number of events 1 • Adverse events were assessed at the informed consent visit (Visit 1), at study day 90 and at the last follow-up telephone contact 30-days after the EOT visit on day 180 (approximately 7 months).
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
1.4%
1/70 • Number of events 1 • Adverse events were assessed at the informed consent visit (Visit 1), at study day 90 and at the last follow-up telephone contact 30-days after the EOT visit on day 180 (approximately 7 months).
|
0.00%
0/67 • Adverse events were assessed at the informed consent visit (Visit 1), at study day 90 and at the last follow-up telephone contact 30-days after the EOT visit on day 180 (approximately 7 months).
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
1.4%
1/70 • Number of events 1 • Adverse events were assessed at the informed consent visit (Visit 1), at study day 90 and at the last follow-up telephone contact 30-days after the EOT visit on day 180 (approximately 7 months).
|
0.00%
0/67 • Adverse events were assessed at the informed consent visit (Visit 1), at study day 90 and at the last follow-up telephone contact 30-days after the EOT visit on day 180 (approximately 7 months).
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
1.4%
1/70 • Number of events 1 • Adverse events were assessed at the informed consent visit (Visit 1), at study day 90 and at the last follow-up telephone contact 30-days after the EOT visit on day 180 (approximately 7 months).
|
0.00%
0/67 • Adverse events were assessed at the informed consent visit (Visit 1), at study day 90 and at the last follow-up telephone contact 30-days after the EOT visit on day 180 (approximately 7 months).
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
1.4%
1/70 • Number of events 1 • Adverse events were assessed at the informed consent visit (Visit 1), at study day 90 and at the last follow-up telephone contact 30-days after the EOT visit on day 180 (approximately 7 months).
|
1.5%
1/67 • Number of events 1 • Adverse events were assessed at the informed consent visit (Visit 1), at study day 90 and at the last follow-up telephone contact 30-days after the EOT visit on day 180 (approximately 7 months).
|
|
Metabolism and nutrition disorders
Vitamin B12 deficiency
|
1.4%
1/70 • Number of events 1 • Adverse events were assessed at the informed consent visit (Visit 1), at study day 90 and at the last follow-up telephone contact 30-days after the EOT visit on day 180 (approximately 7 months).
|
0.00%
0/67 • Adverse events were assessed at the informed consent visit (Visit 1), at study day 90 and at the last follow-up telephone contact 30-days after the EOT visit on day 180 (approximately 7 months).
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
1.4%
1/70 • Number of events 1 • Adverse events were assessed at the informed consent visit (Visit 1), at study day 90 and at the last follow-up telephone contact 30-days after the EOT visit on day 180 (approximately 7 months).
|
0.00%
0/67 • Adverse events were assessed at the informed consent visit (Visit 1), at study day 90 and at the last follow-up telephone contact 30-days after the EOT visit on day 180 (approximately 7 months).
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
0.00%
0/70 • Adverse events were assessed at the informed consent visit (Visit 1), at study day 90 and at the last follow-up telephone contact 30-days after the EOT visit on day 180 (approximately 7 months).
|
1.5%
1/67 • Number of events 1 • Adverse events were assessed at the informed consent visit (Visit 1), at study day 90 and at the last follow-up telephone contact 30-days after the EOT visit on day 180 (approximately 7 months).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
1.4%
1/70 • Number of events 1 • Adverse events were assessed at the informed consent visit (Visit 1), at study day 90 and at the last follow-up telephone contact 30-days after the EOT visit on day 180 (approximately 7 months).
|
1.5%
1/67 • Number of events 1 • Adverse events were assessed at the informed consent visit (Visit 1), at study day 90 and at the last follow-up telephone contact 30-days after the EOT visit on day 180 (approximately 7 months).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign lung neoplasm
|
0.00%
0/70 • Adverse events were assessed at the informed consent visit (Visit 1), at study day 90 and at the last follow-up telephone contact 30-days after the EOT visit on day 180 (approximately 7 months).
|
1.5%
1/67 • Number of events 1 • Adverse events were assessed at the informed consent visit (Visit 1), at study day 90 and at the last follow-up telephone contact 30-days after the EOT visit on day 180 (approximately 7 months).
|
|
Nervous system disorders
Dizziness
|
0.00%
0/70 • Adverse events were assessed at the informed consent visit (Visit 1), at study day 90 and at the last follow-up telephone contact 30-days after the EOT visit on day 180 (approximately 7 months).
|
1.5%
1/67 • Number of events 1 • Adverse events were assessed at the informed consent visit (Visit 1), at study day 90 and at the last follow-up telephone contact 30-days after the EOT visit on day 180 (approximately 7 months).
|
|
Nervous system disorders
Neuropathy peripheral
|
1.4%
1/70 • Number of events 1 • Adverse events were assessed at the informed consent visit (Visit 1), at study day 90 and at the last follow-up telephone contact 30-days after the EOT visit on day 180 (approximately 7 months).
|
0.00%
0/67 • Adverse events were assessed at the informed consent visit (Visit 1), at study day 90 and at the last follow-up telephone contact 30-days after the EOT visit on day 180 (approximately 7 months).
|
|
Nervous system disorders
Syncope
|
0.00%
0/70 • Adverse events were assessed at the informed consent visit (Visit 1), at study day 90 and at the last follow-up telephone contact 30-days after the EOT visit on day 180 (approximately 7 months).
|
1.5%
1/67 • Number of events 1 • Adverse events were assessed at the informed consent visit (Visit 1), at study day 90 and at the last follow-up telephone contact 30-days after the EOT visit on day 180 (approximately 7 months).
|
|
Nervous system disorders
Tremor
|
0.00%
0/70 • Adverse events were assessed at the informed consent visit (Visit 1), at study day 90 and at the last follow-up telephone contact 30-days after the EOT visit on day 180 (approximately 7 months).
|
1.5%
1/67 • Number of events 1 • Adverse events were assessed at the informed consent visit (Visit 1), at study day 90 and at the last follow-up telephone contact 30-days after the EOT visit on day 180 (approximately 7 months).
|
|
Psychiatric disorders
Bipolar disorder
|
0.00%
0/70 • Adverse events were assessed at the informed consent visit (Visit 1), at study day 90 and at the last follow-up telephone contact 30-days after the EOT visit on day 180 (approximately 7 months).
|
1.5%
1/67 • Number of events 1 • Adverse events were assessed at the informed consent visit (Visit 1), at study day 90 and at the last follow-up telephone contact 30-days after the EOT visit on day 180 (approximately 7 months).
|
|
Psychiatric disorders
Depression
|
0.00%
0/70 • Adverse events were assessed at the informed consent visit (Visit 1), at study day 90 and at the last follow-up telephone contact 30-days after the EOT visit on day 180 (approximately 7 months).
|
1.5%
1/67 • Number of events 1 • Adverse events were assessed at the informed consent visit (Visit 1), at study day 90 and at the last follow-up telephone contact 30-days after the EOT visit on day 180 (approximately 7 months).
|
|
Renal and urinary disorders
Bladder hypertrophy
|
1.4%
1/70 • Number of events 1 • Adverse events were assessed at the informed consent visit (Visit 1), at study day 90 and at the last follow-up telephone contact 30-days after the EOT visit on day 180 (approximately 7 months).
|
0.00%
0/67 • Adverse events were assessed at the informed consent visit (Visit 1), at study day 90 and at the last follow-up telephone contact 30-days after the EOT visit on day 180 (approximately 7 months).
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
1.4%
1/70 • Number of events 1 • Adverse events were assessed at the informed consent visit (Visit 1), at study day 90 and at the last follow-up telephone contact 30-days after the EOT visit on day 180 (approximately 7 months).
|
0.00%
0/67 • Adverse events were assessed at the informed consent visit (Visit 1), at study day 90 and at the last follow-up telephone contact 30-days after the EOT visit on day 180 (approximately 7 months).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/70 • Adverse events were assessed at the informed consent visit (Visit 1), at study day 90 and at the last follow-up telephone contact 30-days after the EOT visit on day 180 (approximately 7 months).
|
1.5%
1/67 • Number of events 1 • Adverse events were assessed at the informed consent visit (Visit 1), at study day 90 and at the last follow-up telephone contact 30-days after the EOT visit on day 180 (approximately 7 months).
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
1.4%
1/70 • Number of events 1 • Adverse events were assessed at the informed consent visit (Visit 1), at study day 90 and at the last follow-up telephone contact 30-days after the EOT visit on day 180 (approximately 7 months).
|
0.00%
0/67 • Adverse events were assessed at the informed consent visit (Visit 1), at study day 90 and at the last follow-up telephone contact 30-days after the EOT visit on day 180 (approximately 7 months).
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/70 • Adverse events were assessed at the informed consent visit (Visit 1), at study day 90 and at the last follow-up telephone contact 30-days after the EOT visit on day 180 (approximately 7 months).
|
1.5%
1/67 • Number of events 1 • Adverse events were assessed at the informed consent visit (Visit 1), at study day 90 and at the last follow-up telephone contact 30-days after the EOT visit on day 180 (approximately 7 months).
|
|
Vascular disorders
Hypertension
|
1.4%
1/70 • Number of events 1 • Adverse events were assessed at the informed consent visit (Visit 1), at study day 90 and at the last follow-up telephone contact 30-days after the EOT visit on day 180 (approximately 7 months).
|
3.0%
2/67 • Number of events 2 • Adverse events were assessed at the informed consent visit (Visit 1), at study day 90 and at the last follow-up telephone contact 30-days after the EOT visit on day 180 (approximately 7 months).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The only disclosure restriction on the PI is that within 2 years of study completion, the sponsor must review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review.
- Publication restrictions are in place
Restriction type: OTHER