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

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.

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Drug: Dulera

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 Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15212
      • West Penn Allegheny Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: mometasone furoate/formoterol fumarate dihydrate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Asthma Management Systems
• Collaborators: Merck Sharp & Dohme LLC; West Penn Allegheny Health System
• Investigators: Principal Investigator: Deborah Gentile, DO, West Penn Allegheny Health System

Study record dates

Study Major Dates

• Study Start (Actual): March 4, 2014
• Primary Completion (Actual): July 1, 2017
• Study Completion (Actual): July 12, 2017

Study Registration Dates

• First Submitted: January 23, 2014
• First Submitted That Met QC Criteria: January 23, 2014
• First Posted (Estimate): January 27, 2014

Study Record Updates

• Last Update Posted (Actual): June 20, 2018
• Last Update Submitted That Met QC Criteria: June 19, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: Adherence monitoring; Motivational Interviewing Adherence strategies
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Adrenergic Agonists; Dermatologic Agents; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Anti-Allergic Agents; Adrenergic beta-2 Receptor Agonists; Adrenergic beta-Agonists; Mometasone Furoate; Formoterol Fumarate
• Other Study ID Numbers: RC-5816