Improving Asthma Control in the Real World: A Systematic Approach to Improving Dulera Adherence

• Status: Completed
• Trial end date: 2017-07-12
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Asthma Management Systems
• Collaborators: Merck Sharp & Dohme Corp.; West Penn Allegheny Health System
• Treatments: Formoterol Fumarate; Mometasone Furoate; Mometasone Furoate, Formoterol Fumarate Drug Combination

Criteria

Inclusion Criteria:

1. Physician diagnosis of asthma of moderate severity

2. Subjects ≥ 18 years of age

3. 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

4. Asthma Control Questionnaire (ACQ) result > 1.0 at entry

5. Demonstration of correct inhalation technique for use of meter-dosed inhalers (MDIs)

6. 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

1. Intermittent asthma (asthma exacerbations or symptoms < 3 days/week)

2. Diagnosis of emphysema in prior year

3. 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

4. On any medication documented to have a drug interaction with Dulera