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Completed

NCT Number: NCT02045875

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.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

West Penn Allegheny Health System

Pittsburgh, Pennsylvania, 15212, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Physician diagnosis of asthma of moderate severity
  • Subjects ≥ 18 years of age
  • 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
  • Asthma Control Questionnaire (ACQ) result > 1.0 at entry
  • Demonstration of correct inhalation technique for use of meter-dosed inhalers (MDIs)
  • 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

  • Intermittent asthma (asthma exacerbations or symptoms < 3 days/week)
  • Diagnosis of emphysema in prior year
  • 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
  • On any medication documented to have a drug interaction with Dulera

Treatment and study plan

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.

Other names: mometasone furoate/formoterol fumarate dihydrate

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Asthma Management Systems

Industry

Collaborators

  • Merck Sharp & Dohme LLC
  • West Penn Allegheny Health System

Registry information

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Jan 27, 2014
Registry last updated
Jun 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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