Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02045875
Recruitment Status : Completed
First Posted : January 27, 2014
Results First Posted : June 20, 2018
Last Update Posted : June 20, 2018
Sponsor:
Collaborators:
Merck Sharp & Dohme Corp.
West Penn Allegheny Health System
Information provided by (Responsible Party):
Asthma Management Systems

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Asthma Drug: Dulera Phase 4

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

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Improving Asthma Control in the Real World: A Systematic Approach to Improving Dulera Adherence
Actual Study Start Date : March 4, 2014
Actual Primary Completion Date : July 1, 2017
Actual Study Completion Date : July 12, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
Drug Information available for: Dulera

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Dulera adherence monitoring
Adherence Monitoring Dulera; Identification of adherence barrier(s); Motivational Interviewing Adherence Strategies to promote adherence
 Drug: 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.
Other Name: mometasone furoate/formoterol fumarate dihydrate
Active Comparator: Dulera Standard of Asthma Care
Dulera standard of asthma care
 Drug: 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.
Other Name: mometasone furoate/formoterol fumarate dihydrate


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Asthma Control [ Time Frame: 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 Outcome Measures :
  1. Adherence to Dulera 100/5 and 200/5 [ Time Frame: 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.


  2. Overall Adherence to Dulera 100/5 and 200/5 [ Time Frame: 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



Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02045875


Locations
Layout table for location information
United States, Pennsylvania
West Penn Allegheny Health System
Pittsburgh, Pennsylvania, United States, 15212
Sponsors and Collaborators
Asthma Management Systems
Merck Sharp & Dohme Corp.
West Penn Allegheny Health System
Investigators
Layout table for investigator information
Principal Investigator: Deborah Gentile, DO West Penn Allegheny Health System
  Study Documents (Full-Text)

Documents provided by Asthma Management Systems:
Study Protocol and Statistical Analysis Plan  [PDF] January 6, 2014

More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Asthma Management Systems
ClinicalTrials.gov Identifier: NCT02045875    
Other Study ID Numbers: RC-5816
First Posted: January 27, 2014    Key Record Dates
Results First Posted: June 20, 2018
Last Update Posted: June 20, 2018
Last Verified: February 2018
Keywords provided by Asthma Management Systems:
Adherence monitoring
Motivational Interviewing Adherence strategies
Additional relevant MeSH terms:
Layout table for MeSH terms
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Mometasone Furoate
Formoterol Fumarate
Bronchodilator Agents
Autonomic Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Dermatologic Agents
Anti-Allergic Agents