Improving Asthma Control in the Real World: A Systematic Approach to Improving Dulera Adherence
| Status: | Completed |
|---|---|
| Conditions: | Asthma |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 6/22/2018 |
| Start Date: | March 4, 2014 |
| End Date: | July 12, 2017 |
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.
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
(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
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
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