Asthma
Conditions
Keywords
Adherence monitoring, Motivational Interviewing Adherence strategies
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
Interventions
DRUGDulera
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.
Sponsors
Merck Sharp & Dohme LLC
West Penn Allegheny Health System
Asthma Management Systems
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Dulera Adherence Monitoring 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. | 20 |
| Dulera Standard of Asthma Care 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. | 20 |
| Total | 40 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 3 | 0 |
| Overall Study | Withdrawal by Subject | 4 | 3 |
Baseline characteristics
| Characteristic | Dulera Standard of Asthma Care | Total | Dulera Adherence Monitoring |
|---|---|---|---|
| Age, Continuous | 39 years | 40 years | 41 years |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 20 Participants | 40 Participants | 20 Participants |
| Sex: Female, Male Female | 15 Participants | 27 Participants | 12 Participants |
| Sex: Female, Male Male | 5 Participants | 13 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 27 | 0 / 23 |
| other Total, other adverse events | 0 / 27 | 0 / 23 |
| serious Total, serious adverse events | 0 / 27 | 0 / 23 |
Outcome results
Primary
Asthma Control
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
Population: All patients who completed ACQ at 4 clinical visits were included in the analysis
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dulera Adherence Monitoring | Asthma Control | baseline | 1.857 units on a scale | Standard Deviation 0.924 |
| Dulera Adherence Monitoring | Asthma Control | two month | 1.345 units on a scale | Standard Deviation 1.184 |
| Dulera Adherence Monitoring | Asthma Control | one month | 1.792 units on a scale | Standard Deviation 1.359 |
| Dulera Adherence Monitoring | Asthma Control | three month | 1.105 units on a scale | Standard Deviation 0.806 |
| Dulera Standard of Asthma Care | Asthma Control | one month | 1.578 units on a scale | Standard Deviation 0.855 |
| Dulera Standard of Asthma Care | Asthma Control | baseline | 1.592 units on a scale | Standard Deviation 0.839 |
| Dulera Standard of Asthma Care | Asthma Control | three month | 1.407 units on a scale | Standard Deviation 0.759 |
| Dulera Standard of Asthma Care | Asthma Control | two month | 1.488 units on a scale | Standard Deviation 0.947 |
p-value: 0.046ANOVA
Secondary
Adherence to Dulera 100/5 and 200/5
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
Population: Data was only collected in the interventional group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dulera Adherence Monitoring | Adherence to Dulera 100/5 and 200/5 | week 2 | 88.75 percent of prescribed doses | Standard Deviation 10.43 |
| Dulera Adherence Monitoring | Adherence to Dulera 100/5 and 200/5 | month 1 | 80.7 percent of prescribed doses | Standard Deviation 14.52 |
| Dulera Adherence Monitoring | Adherence to Dulera 100/5 and 200/5 | month 2 | 77.55 percent of prescribed doses | Standard Deviation 19.13 |
| Dulera Adherence Monitoring | Adherence to Dulera 100/5 and 200/5 | month 3 | 76.8 percent of prescribed doses | Standard Deviation 19.83 |
Secondary
Overall Adherence to Dulera 100/5 and 200/5
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
Population: Data was only collected in the interventional group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dulera Adherence Monitoring | Overall Adherence to Dulera 100/5 and 200/5 | 80.95 percent of prescribed doses per day | Standard Deviation 14.23 |