Trial Outcomes & Findings for Study to Evaluate the 24-Hour Pulmonary Function Profile of Fluticasone Furoate/Vilanterol (FF/VI) Inhalation Powder 100/25mcg Once Daily Compared With Tiotropium Bromide Inhalation Powder 18mcg Once Daily in Subjects With COPD Who Have or Are At Risk for Co-morbid Cardiovascular Disease (NCT NCT01627327)
NCT ID: NCT01627327
Last Updated: 2017-11-09
Results Overview
Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcefully exhaled from the lungs in one second. The weighted mean was calculated from the pre-dose FEV1 and post-dose FEV1 measurements at 5, 15, 30 minutes and 1, 2, 4, 6, 8, 12, 13, 14, 16, 20, and 24 hours on Treatment Day 84. Baseline trough FEV1 was the mean of the two assessments made 30 and 5 minutes pre-dose on Treatment Day 1. Change from Baseline (BL) was calculated as the average of the Day 84 values minus the Baseline value. Analysis was performed using an analysis of covariance (ANCOVA) model with covariates of BL FEV1, exacerbation history and reversibility stratum, smoking status at screening, country, and treatment group.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
623 participants
Primary outcome timeframe
Baseline and Day 84
Results posted on
2017-11-09
Participant Flow
Eligible participants (par.) completed a 2-week Run-in Period (RIP) to obtain baseline assessments of rescue use, COPD symptom scores and disease stability. Par. were then randomized to a 12-week Treatment Period. A total of 890 par. were screened, of whom 623 were randomized and received at least one dose of study medication.
Participant milestones
| Measure |
FF/VI 100/25 µg OD
Participants received Fluticasone Furoate /Vilanterol (FF/VI) 100/25 micrograms (µg) inhalation once daily (OD) via a dry powder inhaler (DPI) and placebo inhalation OD via a HandiHaler in the morning for 12 weeks.
|
TIO 18 µg OD
Participants received tiotropium bromide (TIO) 18 µg inhalation OD via a HandiHaler and placebo inhalation OD via a DPI in the morning for 12 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
310
|
313
|
|
Overall Study
COMPLETED
|
291
|
274
|
|
Overall Study
NOT COMPLETED
|
19
|
39
|
Reasons for withdrawal
| Measure |
FF/VI 100/25 µg OD
Participants received Fluticasone Furoate /Vilanterol (FF/VI) 100/25 micrograms (µg) inhalation once daily (OD) via a dry powder inhaler (DPI) and placebo inhalation OD via a HandiHaler in the morning for 12 weeks.
|
TIO 18 µg OD
Participants received tiotropium bromide (TIO) 18 µg inhalation OD via a HandiHaler and placebo inhalation OD via a DPI in the morning for 12 weeks.
|
|---|---|---|
|
Overall Study
Adverse Event
|
6
|
12
|
|
Overall Study
Lack of Efficacy-No Sub-Reason
|
0
|
2
|
|
Overall Study
Lack of Efficacy-Sub-Reason Exacerbation
|
4
|
9
|
|
Overall Study
Protocol Violation
|
4
|
10
|
|
Overall Study
Lost to Follow-up
|
1
|
3
|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
3
|
3
|
Baseline Characteristics
Study to Evaluate the 24-Hour Pulmonary Function Profile of Fluticasone Furoate/Vilanterol (FF/VI) Inhalation Powder 100/25mcg Once Daily Compared With Tiotropium Bromide Inhalation Powder 18mcg Once Daily in Subjects With COPD Who Have or Are At Risk for Co-morbid Cardiovascular Disease
Baseline characteristics by cohort
| Measure |
FF/VI 100/25 µg OD
n=310 Participants
Participants received FF/VI 100/25 µg inhalation OD via a DPI and placebo inhalation OD via a HandiHaler in the morning for 12 weeks.
|
TIO 18 µg OD
n=313 Participants
Participants received TIO 18 µg inhalation OD via a HandiHaler and placebo inhalation OD via a DPI in the morning for 12 weeks.
|
Total
n=623 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.9 Years
STANDARD_DEVIATION 8.09 • n=99 Participants
|
62.3 Years
STANDARD_DEVIATION 7.98 • n=107 Participants
|
62.6 Years
STANDARD_DEVIATION 8.03 • n=206 Participants
|
|
Sex: Female, Male
Female
|
117 Participants
n=99 Participants
|
104 Participants
n=107 Participants
|
221 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
193 Participants
n=99 Participants
|
209 Participants
n=107 Participants
|
402 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
African American/African Heritage
|
8 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian - East Asian Heritage
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White - White/Caucasian/European Heritage
|
302 Participants
n=99 Participants
|
305 Participants
n=107 Participants
|
607 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline and Day 84Population: Intent-to-Treat (ITT) Population: all participants who were randomized and received at least one dose of study medication. Only participants with data available at the indicated time point were assessed.
Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcefully exhaled from the lungs in one second. The weighted mean was calculated from the pre-dose FEV1 and post-dose FEV1 measurements at 5, 15, 30 minutes and 1, 2, 4, 6, 8, 12, 13, 14, 16, 20, and 24 hours on Treatment Day 84. Baseline trough FEV1 was the mean of the two assessments made 30 and 5 minutes pre-dose on Treatment Day 1. Change from Baseline (BL) was calculated as the average of the Day 84 values minus the Baseline value. Analysis was performed using an analysis of covariance (ANCOVA) model with covariates of BL FEV1, exacerbation history and reversibility stratum, smoking status at screening, country, and treatment group.
Outcome measures
| Measure |
FF/VI 100/25 µg OD
n=254 Participants
Participants received FF/VI 100/25 µg inhalation OD via a DPI and placebo inhalation OD via a HandiHaler in the morning for 12 weeks.
|
TIO 18 µg OD
n=236 Participants
Participants received TIO 18 µg inhalation OD via a HandiHaler and placebo inhalation OD via a DPI in the morning for 12 weeks.
|
|---|---|---|
|
Change From Baseline Trough in 24-hour Weighted Mean FEV1 on Treatment Day 84
|
0.117 Liters
Standard Error 0.0130
|
0.095 Liters
Standard Error 0.0138
|
SECONDARY outcome
Timeframe: Baseline and Day 1Population: ITT Population. Only participants with data available at the indicated time point were assessed.
Time to onset on Treatment Day 1 is defined as the time to an increase of 100 milliliters (mL) from Baseline in FEV1. Time of onset was calculated over 0 to 4 hours (5 minutes (min), 15 min, 30 min, 60 min, 120 min, and 240 min) post-dose. Time to onset was analyzed using a log-rank test, stratified by exacerbation history and reversibility stratum.
Outcome measures
| Measure |
FF/VI 100/25 µg OD
n=239 Participants
Participants received FF/VI 100/25 µg inhalation OD via a DPI and placebo inhalation OD via a HandiHaler in the morning for 12 weeks.
|
TIO 18 µg OD
n=254 Participants
Participants received TIO 18 µg inhalation OD via a HandiHaler and placebo inhalation OD via a DPI in the morning for 12 weeks.
|
|---|---|---|
|
Time to Onset on Treatment Day 1
|
17.0 Minutes
Interval 5.0 to 240.0
|
20.5 Minutes
Interval 5.0 to 240.0
|
SECONDARY outcome
Timeframe: Baseline and Day 84Population: ITT Population. Only participants with data available at the indicated time point were assessed.
Pulmonary function was measured by FEV1. Trough FEV1 was defined as the 24-hour FEV1 assessment, which was obtained on Day 84. Baseline is defined as the mean of the two assessments made 30 minutes pre-dose and 5 minutes pre-dose on Treatment Day 1.Change from Baseline was calculated as the average of the Day 84 values minus the Baseline value. Analysis was performed using an ANCOVA model with covariates of BL FEV1, exacerbation history and reversibility stratum, smoking status at screening, country, and treatment group.
Outcome measures
| Measure |
FF/VI 100/25 µg OD
n=268 Participants
Participants received FF/VI 100/25 µg inhalation OD via a DPI and placebo inhalation OD via a HandiHaler in the morning for 12 weeks.
|
TIO 18 µg OD
n=249 Participants
Participants received TIO 18 µg inhalation OD via a HandiHaler and placebo inhalation OD via a DPI in the morning for 12 weeks.
|
|---|---|---|
|
Change From Baseline in Trough FEV1 at Treatment Day 84
|
0.098 Liters
Standard Error 0.0133
|
0.093 Liters
Standard Error 0.0140
|
Adverse Events
FF/VI 100/25 µg OD
Serious events: 10 serious events
Other events: 31 other events
Deaths: 0 deaths
TIO 18 µg OD
Serious events: 10 serious events
Other events: 32 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
FF/VI 100/25 µg OD
n=310 participants at risk
Participants received FF/VI 100/25 µg inhalation OD via a DPI and placebo inhalation OD via a HandiHaler in the morning for 12 weeks.
|
TIO 18 µg OD
n=313 participants at risk
Participants received TIO 18 µg inhalation OD via a HandiHaler and placebo inhalation OD via a DPI in the morning for 12 weeks.
|
|---|---|---|
|
Infections and infestations
Pneumonia
|
0.97%
3/310 • On-Treatment serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until Follow-up (up to 13 weeks).
An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of study medication.
|
0.00%
0/313 • On-Treatment serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until Follow-up (up to 13 weeks).
An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of study medication.
|
|
Infections and infestations
Urinary tract infection
|
0.65%
2/310 • On-Treatment serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until Follow-up (up to 13 weeks).
An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of study medication.
|
0.00%
0/313 • On-Treatment serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until Follow-up (up to 13 weeks).
An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of study medication.
|
|
Infections and infestations
Graft infection
|
0.00%
0/310 • On-Treatment serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until Follow-up (up to 13 weeks).
An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of study medication.
|
0.32%
1/313 • On-Treatment serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until Follow-up (up to 13 weeks).
An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of study medication.
|
|
Infections and infestations
Post procedural infection
|
0.32%
1/310 • On-Treatment serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until Follow-up (up to 13 weeks).
An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of study medication.
|
0.00%
0/313 • On-Treatment serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until Follow-up (up to 13 weeks).
An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of study medication.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/310 • On-Treatment serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until Follow-up (up to 13 weeks).
An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of study medication.
|
0.64%
2/313 • On-Treatment serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until Follow-up (up to 13 weeks).
An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of study medication.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/310 • On-Treatment serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until Follow-up (up to 13 weeks).
An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of study medication.
|
0.32%
1/313 • On-Treatment serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until Follow-up (up to 13 weeks).
An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of study medication.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/310 • On-Treatment serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until Follow-up (up to 13 weeks).
An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of study medication.
|
0.32%
1/313 • On-Treatment serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until Follow-up (up to 13 weeks).
An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of study medication.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/310 • On-Treatment serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until Follow-up (up to 13 weeks).
An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of study medication.
|
0.32%
1/313 • On-Treatment serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until Follow-up (up to 13 weeks).
An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.00%
0/310 • On-Treatment serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until Follow-up (up to 13 weeks).
An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of study medication.
|
0.32%
1/313 • On-Treatment serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until Follow-up (up to 13 weeks).
An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Anaemia postoperative
|
0.32%
1/310 • On-Treatment serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until Follow-up (up to 13 weeks).
An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of study medication.
|
0.00%
0/313 • On-Treatment serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until Follow-up (up to 13 weeks).
An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Cardiac procedure complication
|
0.00%
0/310 • On-Treatment serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until Follow-up (up to 13 weeks).
An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of study medication.
|
0.32%
1/313 • On-Treatment serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until Follow-up (up to 13 weeks).
An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.32%
1/310 • On-Treatment serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until Follow-up (up to 13 weeks).
An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of study medication.
|
0.00%
0/313 • On-Treatment serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until Follow-up (up to 13 weeks).
An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.65%
2/310 • On-Treatment serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until Follow-up (up to 13 weeks).
An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of study medication.
|
0.32%
1/313 • On-Treatment serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until Follow-up (up to 13 weeks).
An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of study medication.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/310 • On-Treatment serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until Follow-up (up to 13 weeks).
An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of study medication.
|
0.32%
1/313 • On-Treatment serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until Follow-up (up to 13 weeks).
An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of study medication.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/310 • On-Treatment serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until Follow-up (up to 13 weeks).
An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of study medication.
|
0.32%
1/313 • On-Treatment serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until Follow-up (up to 13 weeks).
An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of study medication.
|
|
Vascular disorders
Blood pressure fluctuation
|
0.32%
1/310 • On-Treatment serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until Follow-up (up to 13 weeks).
An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of study medication.
|
0.00%
0/313 • On-Treatment serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until Follow-up (up to 13 weeks).
An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of study medication.
|
|
Vascular disorders
Leriche syndrome
|
0.00%
0/310 • On-Treatment serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until Follow-up (up to 13 weeks).
An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of study medication.
|
0.32%
1/313 • On-Treatment serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until Follow-up (up to 13 weeks).
An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of study medication.
|
|
Vascular disorders
Thrombosis
|
0.32%
1/310 • On-Treatment serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until Follow-up (up to 13 weeks).
An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of study medication.
|
0.00%
0/313 • On-Treatment serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until Follow-up (up to 13 weeks).
An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.32%
1/310 • On-Treatment serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until Follow-up (up to 13 weeks).
An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of study medication.
|
0.00%
0/313 • On-Treatment serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until Follow-up (up to 13 weeks).
An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of study medication.
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/310 • On-Treatment serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until Follow-up (up to 13 weeks).
An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of study medication.
|
0.32%
1/313 • On-Treatment serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until Follow-up (up to 13 weeks).
An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of study medication.
|
|
Psychiatric disorders
Alcohol abuse
|
0.00%
0/310 • On-Treatment serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until Follow-up (up to 13 weeks).
An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of study medication.
|
0.32%
1/313 • On-Treatment serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until Follow-up (up to 13 weeks).
An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of study medication.
|
|
Psychiatric disorders
Depression
|
0.00%
0/310 • On-Treatment serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until Follow-up (up to 13 weeks).
An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of study medication.
|
0.32%
1/313 • On-Treatment serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until Follow-up (up to 13 weeks).
An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of study medication.
|
Other adverse events
| Measure |
FF/VI 100/25 µg OD
n=310 participants at risk
Participants received FF/VI 100/25 µg inhalation OD via a DPI and placebo inhalation OD via a HandiHaler in the morning for 12 weeks.
|
TIO 18 µg OD
n=313 participants at risk
Participants received TIO 18 µg inhalation OD via a HandiHaler and placebo inhalation OD via a DPI in the morning for 12 weeks.
|
|---|---|---|
|
Nervous system disorders
Headache
|
5.8%
18/310 • On-Treatment serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until Follow-up (up to 13 weeks).
An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of study medication.
|
7.3%
23/313 • On-Treatment serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until Follow-up (up to 13 weeks).
An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of study medication.
|
|
Infections and infestations
Nasopharyngitis
|
5.2%
16/310 • On-Treatment serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until Follow-up (up to 13 weeks).
An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of study medication.
|
4.2%
13/313 • On-Treatment serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until Follow-up (up to 13 weeks).
An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of study medication.
|
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER