A Phase 4 interventional study of Dulera in Asthma, sponsored by Asthma Management Systems. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-06-20.
Sponsored by Asthma Management Systems · Phase 4, Interventional, and Treatment
40 subjects with moderate-to-severe asthma will be randomly selected for study in which 20, will be monitored for medication use (Dulera 100/5, Dulera 200/5 and Proventil HFA) over 3 months. These intervention subjects will receive medication use feedback at each visit, while the control group will receive the standard of asthma care. Those interventional subjects with Dulera adherence\<60% will receive feedback based on an asthma adherence disease management model protocol, Asthma Adherence Pathway. Intervention clinicians will been trained in Motivational Interviewing to reduce subject ambivalence about medication use. The primary hypothesis is that subjects who receive medication monitoring and Motivational Interviewing adherence strategies will have better asthma control, as measured by the Asthma Control Questionnaire, than the control group.
Primary Clinical Hypothesis: Poorly controlled subjects with moderate-to-severe asthma (measured by Asthma Control Questionnaire (ACQ) ≥ 1) despite treatment with Dulera, who are treated with the asthma adherence disease management protocol, Asthma Adherence Pathway™, will achieve greater asthma control than similar control subjects who are treated with the current standard of care.
Primary end point: There will be four measures of Asthma Control Questionnaire (ACQ) over time over 3 months. The primary endpoint is the third month measure of ACQ.
Secondary Clinical Hypothesis: The asthma adherence disease management program, Asthma Adherence Pathway™, will increase observed adherence to Dulera relative to a benchmark of 60% adherence (i.e., expected prescribed actuations).
Secondary end points: a) Average adherence to Dulera over the three month study period
Tertiary Clinical Hypothesis: Responses to Adult Asthma Adherence Questionnaire (AAAQ) will be related to Dulera Adherence
Tertiary Study Endpoints: There will be 2 measures of the AAAQ (first and last visit) and the tertiary endpoint is the last visit
3,921 studies on the registry are indexed under Asthma; 506 are open to participants now.
This study's enrollment of 50 is below the median of 83 across 2,751 interventional studies indexed under Asthma.
Browse Asthma studies →This is the only study on the registry with Asthma Management Systems as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria
Adherence Monitoring Dulera; Identification of adherence barrier(s); Motivational Interviewing Adherence Strategies to promote adherence
Drug: Dulera
Dulera standard of asthma care
Drug: 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.
Also known as: mometasone furoate/formoterol fumarate dihydrate
Asthma Control
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.
Time frame: Baseline, one, two and three months
Adherence to Dulera 100/5 and 200/5
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.
Time frame: week 2. months 1, 2, and 3
Overall Adherence to Dulera 100/5 and 200/5
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
Time frame: 3 months
| Milestone | Dulera Adherence Monitoring | Dulera Standard of Asthma Care |
|---|---|---|
| Started | 27 | 23 |
| Completed | 20 | 20 |
| Not completed | 7 | 3 |
| Withdrew: Lost to follow-up | 3 | 0 |
| Withdrew: Withdrawal by subject | 4 | 3 |
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.
| units on a scale | Dulera Adherence Monitoring | Dulera Standard of Asthma Care |
|---|---|---|
| baseline | 1.857 ± 0.924 | 1.592 ± 0.839 |
| one month | 1.792 ± 1.359 | 1.578 ± 0.855 |
| two month | 1.345 ± 1.184 | 1.488 ± 0.947 |
| three month | 1.105 ± 0.806 | 1.407 ± 0.759 |
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.
| percent of prescribed doses | Dulera Adherence Monitoring |
|---|---|
| week 2 | 88.75 ± 10.43 |
| month 1 | 80.7 ± 14.52 |
| month 2 | 77.55 ± 19.13 |
| month 3 | 76.8 ± 19.83 |
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
| percent of prescribed doses per day | Dulera Adherence Monitoring |
|---|---|
| Overall Adherence to Dulera 100/5 and 200/5 | 80.95 ± 14.23 |
Collected over 3 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Dulera Adherence Monitoring | 0/27 (0%) | 0/27 (0%) | 0/27 (0%) |
| Dulera Standard of Asthma Care | 0/23 (0%) | 0/23 (0%) | 0/23 (0%) |
| Age, Continuous(years) | Dulera Adherence Monitoring | Dulera Standard of Asthma Care | Total |
|---|---|---|---|
| Mean | 41 (23 to 67) | 39 (26 to 69) | 40 (23 to 69) |
| Sex: Female, Male(Participants) | Dulera Adherence Monitoring | Dulera Standard of Asthma Care | Total |
|---|---|---|---|
| Female | 12 | 15 | 27 |
| Male | 8 | 5 | 13 |
| Race and Ethnicity Not Collected(Participants) | Dulera Adherence Monitoring | Dulera Standard of Asthma Care | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(Participants) | Dulera Adherence Monitoring | Dulera Standard of Asthma Care | Total |
|---|---|---|---|
| United States | 20 | 20 | 40 |
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