Phase 4
N=50
Improving Asthma Control in the Real World: A Systematic Approach to Improving Dulera Adherence
Asthma
Bottom Line
View on ClinicalTrials.gov: NCT02045875 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Jun 2018
Primary outcome: Primary: Asthma Control — 1.857; 1.592; 1.792; 1.578 units on a scale — p=0.046
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Dulera (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Asthma Management Systems
- Primary completion
- Jul 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Asthma Control |
1.857; 1.592; 1.792; 1.578; 1.345; 1.488 | 0.046 sig |
| SECONDARY Adherence to Dulera 100/5 and 200/5 |
88.75; 80.7; 77.55; 76.8 | — |
| SECONDARY Overall Adherence to Dulera 100/5 and 200/5 |
80.95 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT02045875). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.