Trial Outcomes & Findings for Improving Asthma Control in the Real World: A Systematic Approach to Improving Dulera Adherence (NCT NCT02045875)
NCT ID: NCT02045875
Last Updated: 2018-06-20
Results Overview
Asthma Control Questionnaire measured at each office visit. ACQ integrates values by 6 clinical questions related to symptoms and the value related to FEV1% predicted with a total score ranging from 0-6 and higher values indicating poorer asthma control.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
50 participants
Primary outcome timeframe
Baseline, one, two and three months
Results posted on
2018-06-20
Participant Flow
Participant milestones
| Measure |
Dulera Adherence Monitoring
Adherence Monitoring Dulera; Identification of adherence barrier(s); Motivational Interviewing Adherence Strategies to promote adherence
Dulera: Dulera is a combination product containing a corticosteroid and a long-acting beta2-adrenergic agonist, FDA approved and indicated for treatment of asthma in patients 12 years of age and older.
|
Dulera Standard of Asthma Care
Dulera standard of asthma care
Dulera: Dulera is a combination product containing a corticosteroid and a long-acting beta2-adrenergic agonist, FDA approved and indicated for treatment of asthma in patients 12 years of age and older.
|
|---|---|---|
|
Overall Study
STARTED
|
27
|
23
|
|
Overall Study
COMPLETED
|
20
|
20
|
|
Overall Study
NOT COMPLETED
|
7
|
3
|
Reasons for withdrawal
| Measure |
Dulera Adherence Monitoring
Adherence Monitoring Dulera; Identification of adherence barrier(s); Motivational Interviewing Adherence Strategies to promote adherence
Dulera: Dulera is a combination product containing a corticosteroid and a long-acting beta2-adrenergic agonist, FDA approved and indicated for treatment of asthma in patients 12 years of age and older.
|
Dulera Standard of Asthma Care
Dulera standard of asthma care
Dulera: Dulera is a combination product containing a corticosteroid and a long-acting beta2-adrenergic agonist, FDA approved and indicated for treatment of asthma in patients 12 years of age and older.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
0
|
|
Overall Study
Withdrawal by Subject
|
4
|
3
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Dulera Adherence Monitoring
n=20 Participants
Adherence Monitoring Dulera; Identification of adherence barrier(s); Motivational Interviewing Adherence Strategies to promote adherence
Dulera: Dulera is a combination product containing a corticosteroid and a long-acting beta2-adrenergic agonist, FDA approved and indicated for treatment of asthma in patients 12 years of age and older.
|
Dulera Standard of Asthma Care
n=20 Participants
Dulera standard of asthma care
Dulera: Dulera is a combination product containing a corticosteroid and a long-acting beta2-adrenergic agonist, FDA approved and indicated for treatment of asthma in patients 12 years of age and older.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
41 years
n=20 Participants
|
39 years
n=20 Participants
|
40 years
n=40 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=20 Participants
|
15 Participants
n=20 Participants
|
27 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=20 Participants
|
5 Participants
n=20 Participants
|
13 Participants
n=40 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
20 Participants
n=20 Participants
|
20 Participants
n=20 Participants
|
40 Participants
n=40 Participants
|
PRIMARY outcome
Timeframe: Baseline, one, two and three monthsPopulation: All patients who completed ACQ at 4 clinical visits were included in the analysis
Asthma Control Questionnaire measured at each office visit. ACQ integrates values by 6 clinical questions related to symptoms and the value related to FEV1% predicted with a total score ranging from 0-6 and higher values indicating poorer asthma control.
Outcome measures
| Measure |
Dulera Adherence Monitoring
n=19 Participants
Adherence Monitoring Dulera; Identification of adherence barrier(s); Motivational Interviewing Adherence Strategies to promote adherence
Dulera: Dulera is a combination product containing a corticosteroid and a long-acting beta2-adrenergic agonist, FDA approved and indicated for treatment of asthma in patients 12 years of age and older.
|
Dulera Standard of Asthma Care
n=20 Participants
Dulera standard of asthma care
Dulera: Dulera is a combination product containing a corticosteroid and a long-acting beta2-adrenergic agonist, FDA approved and indicated for treatment of asthma in patients 12 years of age and older.
|
|---|---|---|
|
Asthma Control
baseline
|
1.857 units on a scale
Standard Deviation 0.924
|
1.592 units on a scale
Standard Deviation 0.839
|
|
Asthma Control
one month
|
1.792 units on a scale
Standard Deviation 1.359
|
1.578 units on a scale
Standard Deviation 0.855
|
|
Asthma Control
two month
|
1.345 units on a scale
Standard Deviation 1.184
|
1.488 units on a scale
Standard Deviation 0.947
|
|
Asthma Control
three month
|
1.105 units on a scale
Standard Deviation 0.806
|
1.407 units on a scale
Standard Deviation 0.759
|
SECONDARY outcome
Timeframe: week 2. months 1, 2, and 3Population: Data was only collected in the interventional group.
Subjects in the monitoring group will have adherence greater than or equal to the 60% benchmark Adherence was calculated by taking the number of doses actually taken divided by the number of doses prescribed and multiplying by 100.
Outcome measures
| Measure |
Dulera Adherence Monitoring
n=20 Participants
Adherence Monitoring Dulera; Identification of adherence barrier(s); Motivational Interviewing Adherence Strategies to promote adherence
Dulera: Dulera is a combination product containing a corticosteroid and a long-acting beta2-adrenergic agonist, FDA approved and indicated for treatment of asthma in patients 12 years of age and older.
|
Dulera Standard of Asthma Care
Dulera standard of asthma care
Dulera: Dulera is a combination product containing a corticosteroid and a long-acting beta2-adrenergic agonist, FDA approved and indicated for treatment of asthma in patients 12 years of age and older.
|
|---|---|---|
|
Adherence to Dulera 100/5 and 200/5
week 2
|
88.75 percent of prescribed doses
Standard Deviation 10.43
|
—
|
|
Adherence to Dulera 100/5 and 200/5
month 1
|
80.7 percent of prescribed doses
Standard Deviation 14.52
|
—
|
|
Adherence to Dulera 100/5 and 200/5
month 2
|
77.55 percent of prescribed doses
Standard Deviation 19.13
|
—
|
|
Adherence to Dulera 100/5 and 200/5
month 3
|
76.8 percent of prescribed doses
Standard Deviation 19.83
|
—
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Data was only collected in the interventional group.
Subjects in the monitoring group will have adherence greater than or equal to the 60% benchmark Overall interval value was the mean of daily percent
Outcome measures
| Measure |
Dulera Adherence Monitoring
n=20 Participants
Adherence Monitoring Dulera; Identification of adherence barrier(s); Motivational Interviewing Adherence Strategies to promote adherence
Dulera: Dulera is a combination product containing a corticosteroid and a long-acting beta2-adrenergic agonist, FDA approved and indicated for treatment of asthma in patients 12 years of age and older.
|
Dulera Standard of Asthma Care
Dulera standard of asthma care
Dulera: Dulera is a combination product containing a corticosteroid and a long-acting beta2-adrenergic agonist, FDA approved and indicated for treatment of asthma in patients 12 years of age and older.
|
|---|---|---|
|
Overall Adherence to Dulera 100/5 and 200/5
|
80.95 percent of prescribed doses per day
Standard Deviation 14.23
|
—
|
Adverse Events
Dulera Adherence Monitoring
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Dulera Standard of Asthma Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place