Improving Asthma Control in the Real World: A Systematic Approach to Improving Dulera Adherence
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 4 |
Detailed Description
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
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Dulera adherence monitoring Adherence Monitoring Dulera; Identification of adherence barrier(s); Motivational Interviewing Adherence Strategies to promote adherence |
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.
Other Names:
|
| Active Comparator: Dulera Standard of Asthma Care 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.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Asthma Control [Baseline, one, two and three months]
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.
Secondary Outcome Measures
- Adherence to Dulera 100/5 and 200/5 [week 2. months 1, 2, and 3]
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.
- Overall Adherence to Dulera 100/5 and 200/5 [3 months]
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
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Physician diagnosis of asthma of moderate severity
-
Subjects ≥ 18 years of age
-
Currently receiving an inhaled corticosteroid medication and being prescribed Dulera 100/5 as part of standard of care based upon asthma severity and dosing guidelines
-
Asthma Control Questionnaire (ACQ) result > 1.0 at entry
-
Demonstration of correct inhalation technique for use of meter-dosed inhalers (MDIs)
-
History of reversible airway obstruction documented by treating physician Exclusion Criteria: intermittent asthma; emphysema, chronic obstructive pulmonary disease; chronic bronchitis; cystic fibrosis; medication that may have a drug interaction with Dulera
Exclusion Criteria
-
Intermittent asthma (asthma exacerbations or symptoms < 3 days/week)
-
Diagnosis of emphysema in prior year
-
Diagnosis at any time of: chronic obstructive pulmonary disease (COPD), chronic bronchitis, cystic fibrosis, bronchiectasis, Churg Strauss, Wegener's, sarcoidosis, pulmonary hypertension or lung cancer
-
On any medication documented to have a drug interaction with Dulera
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | West Penn Allegheny Health System | Pittsburgh | Pennsylvania | United States | 15212 |
Sponsors and Collaborators
- Asthma Management Systems
- Merck Sharp & Dohme LLC
- West Penn Allegheny Health System
Investigators
- Principal Investigator: Deborah Gentile, DO, West Penn Allegheny Health System
Study Documents (Full-Text)
More Information
Publications
None provided.- RC-5816
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Dulera Adherence Monitoring | Dulera Standard of Asthma Care |
|---|---|---|
| Arm/Group Description | 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: 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. |
| Period Title: Overall Study | ||
| STARTED | 27 | 23 |
| COMPLETED | 20 | 20 |
| NOT COMPLETED | 7 | 3 |
Baseline Characteristics
| Arm/Group Title | Dulera Adherence Monitoring | Dulera Standard of Asthma Care | Total |
|---|---|---|---|
| Arm/Group Description | 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: 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 of all reporting groups |
| Overall Participants | 20 | 20 | 40 |
| Age (years) [Mean (Full Range) ] | |||
| Mean (Full Range) [years] |
41
|
39
|
40
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
12
60%
|
15
75%
|
27
67.5%
|
| Male |
8
40%
|
5
25%
|
13
32.5%
|
| Race and Ethnicity Not Collected (Count of Participants) | |||
| Count of Participants [Participants] |
0
0%
|
||
| Region of Enrollment (Count of Participants) | |||
| United States |
20
100%
|
20
100%
|
40
100%
|
Outcome Measures
| Title | Asthma Control |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All patients who completed ACQ at 4 clinical visits were included in the analysis |
| Arm/Group Title | Dulera Adherence Monitoring | Dulera Standard of Asthma Care |
|---|---|---|
| Arm/Group Description | 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: 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. |
| Measure Participants | 19 | 20 |
| 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)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Dulera Adherence Monitoring, Dulera Standard of Asthma Care |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.046 |
| Comments | Effect of interaction of time and treatment group | |
| Method | ANOVA | |
| Comments | ||
| Title | Adherence to Dulera 100/5 and 200/5 |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Data was only collected in the interventional group. |
| Arm/Group Title | Dulera Adherence Monitoring |
|---|---|
| Arm/Group Description | 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. |
| Measure Participants | 20 |
| week 2 |
88.75
(10.43)
|
| month 1 |
80.7
(14.52)
|
| month 2 |
77.55
(19.13)
|
| month 3 |
76.8
(19.83)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Dulera Adherence Monitoring |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | correlation coefficient |
| Estimated Value | -0.508 | |
| Confidence Interval |
(2-Sided) % to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | correlation of asthma control and adherence | |
| Title | Overall Adherence to Dulera 100/5 and 200/5 |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Data was only collected in the interventional group. |
| Arm/Group Title | Dulera Adherence Monitoring |
|---|---|
| Arm/Group Description | 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. |
| Measure Participants | 20 |
| Mean (Standard Deviation) [percent of prescribed doses per day] |
80.95
(14.23)
|
Adverse Events
| Time Frame | 3 months | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Dulera Adherence Monitoring | Dulera Standard of Asthma Care | ||
| Arm/Group Description | 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: 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. | ||
All Cause Mortality |
||||
| Dulera Adherence Monitoring | Dulera Standard of Asthma Care | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/27 (0%) | 0/23 (0%) | ||
Serious Adverse Events |
||||
| Dulera Adherence Monitoring | Dulera Standard of Asthma Care | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/27 (0%) | 0/23 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Dulera Adherence Monitoring | Dulera Standard of Asthma Care | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/27 (0%) | 0/23 (0%) | ||
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Andrew G Weinstein MD |
|---|---|
| Organization | Asthma Management Systems |
| Phone | 302 893 5455 |
| agwmd@aol.com |
- RC-5816