Clinical trial NCT02045875: Improving Asthma Control in the Real World: A Systematic Approach to Improving Dulera Adherence
Official title: Improving Asthma Control in the Real World: A Systematic Approach to Improving Dulera Adherence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Asthma
Keywords: Adherence monitoring
Motivational Interviewing Adherence strategies
Lead sponsor: Asthma Management Systems
Sponsor class: INDUSTRY
Collaborators: name: Merck Sharp & Dohme LLC
name: West Penn Allegheny Health System
First posted: 2014-01-27
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Eligibility 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

Primary outcomes:
measure: Asthma Control
timeFrame: Baseline, one, two and three months
Secondary outcomes:
measure: Adherence to Dulera 100/5 and 200/5
timeFrame: week 2. months 1, 2, and 3
measure: Overall Adherence to Dulera 100/5 and 200/5
timeFrame: 3 months
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: West Penn Allegheny Health System
state: Pennsylvania
Study officials:
affiliation: West Penn Allegheny Health System
name: Deborah Gentile, DO
role: PRINCIPAL_INVESTIGATOR
References: