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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
| West Penn Allegheny Health System | OTHER |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dulera adherence monitoring | Experimental | Adherence Monitoring Dulera; Identification of adherence barrier(s); Motivational Interviewing Adherence Strategies to promote adherence |
|
| Dulera Standard of Asthma Care | Active Comparator | Dulera standard of asthma care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dulera | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, one, two and three months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | week 2. months 1, 2, and 3 |
| Overall Adherence to Dulera 100/5 and 200/5 |
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Inclusion Criteria:
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Deborah Gentile, DO | West Penn Allegheny Health System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West Penn Allegheny Health System | Pittsburgh | Pennsylvania | 15212 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | All patients who completed ACQ at 4 clinical visits were included in the analysis | Posted | Mean | Standard Deviation | units on a scale | Baseline, one, two and three months |
|
3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Andrew G Weinstein MD | Asthma Management Systems | 302 893 5455 | agwmd@aol.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 6, 2014 | May 8, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| D000068758 | Mometasone Furoate, Formoterol Fumarate Drug Combination |
| D000068656 | Mometasone Furoate |
| ID | Term |
|---|---|
| D000068759 | Formoterol Fumarate |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
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|
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 |
| 3 months |
| BG001 |
| 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 |
| 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. |
|
|
|
| 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. | Data was only collected in the interventional group. | Posted | Mean | Standard Deviation | percent of prescribed doses | week 2. months 1, 2, and 3 |
|
|
|
|
| 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 | Data was only collected in the interventional group. | Posted | Mean | Standard Deviation | percent of prescribed doses per day | 3 months |
|
|
|
| 0 |
| 27 |
| 0 |
| 27 |
| 0 |
| 27 |
| EG001 | 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. | 0 | 23 | 0 | 23 | 0 | 23 |
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| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D009930 |
| Organic Chemicals |
| D000588 | Amines |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
| Title | Measurements |
|---|---|
|
| month 3 |
|