There are currently no treatments to specifically target asthma in obese adults. This pilot study is being conducted to investigate how effective roflumilast is in treating asthma in participants that have a higher BMI. Roflumilast can induce weight loss, which may lead to improved asthma control. The primary objective of TRIM is to perform a pilot placebo-controlled trial of roflumilast for the treatment of poorly controlled obese asthmatics.
TRIM is a 24 week, randomized, double-masked, placebo controlled trial that will enroll 38 participants. This study will be take place in seven centers of the American Lung Association- Airways Clinical Research Centers (ALA-ACRC). The centers include: Northwestern University Feinberg School of Medicine, Mount Sinai Icahn School of Medicine, Duke University, University of Arizona, the University of Vermont, The University of Alabama Lung Health Center, and University of Illinois Breathe Chicago Center. Johns Hopkins University will be the Data Coordinating Center (DCC) for the trial.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
38
The first two weeks the participant will take one tablet every other day. If well tolerated, participant will take one tablet every day.
The first two weeks the participant will take one tablet every other day. If well tolerated, participant will take one tablet every day.
University of Alabama Lung Health Center
Birmingham, Alabama, United States
University of Arizona
Tucson, Arizona, United States
University of Illinois at Chicago, Breathe Chicago Center
Chicago, Illinois, United States
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States
Change in Asthma Control Test Score
The Asthma Control Test was designed to help participants describe their asthma and how it affects how they feel and what they are able to do. They choose a response based on their asthma within the last 4 weeks. Participants select how many times per week they experience different asthma symptoms and how often they had to use a rescue inhaler or nebulizer. There are 5 questions with 5 responses; 1 meaning their asthma is not well controlled or they had symptoms more frequently, through 5 meaning they feel their asthma is well controlled or they do not experience any symptoms. The primary outcome is an unadjusted comparison of 24 week change in Asthma Control Test scores between the treatment groups.
Time frame: Baseline and 24 weeks
Change in Weight
Weight change measured in kilograms (kg).
Time frame: Baseline and 24 weeks
Change in Asthma Symptom Utility Index (ASUI)
A 10-item questionnaire, patient preference-based scale assessing frequency and severity of selected asthma-related symptoms and treatment side effects, for use in clinical trials and cost-effectiveness studies in asthma. Range is 0-1. Higher score is indicative of better health.
Time frame: baseline and 24 weeks
Change in Gastrointestinal Symptom Rating Scale (GSRS)
It has 5 subscales (Reflux, Diarrhea, Constipation, Abdominal Pain, and Indigestion Syndrome). Subscale scores range from 1 to 7 and higher scores represent more discomfort and poor health.
Time frame: Baseline and 24 weeks
Change in Generalized Anxiety Disease (GAD-7)
GAD-7 has 7 questions. The GAD-7 score is calculated by assigning scores of 0, 1, 2, and 3, to the response categories of 'not at all', 'several days', 'more than half the days', and 'nearly every day', respectively, and adding together the scores for the seven questions. The following cut-offs correlate with level of anxiety severity: Score 0-4: Minimal Anxiety Score 5-9: Mild Anxiety Score 10-14: Moderate Anxiety Score greater than 15: Severe Anxiety
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Mount Sinai Icahn School of Medicine
New York, New York, United States
Duke University
Durham, North Carolina, United States
University of Vermont
Colchester, Vermont, United States
Time frame: baseline and 24 weeks
Change in Marks Asthma Quality of Life Questionnaire
20 items with 2 week recall. Self-administered questionnaire intended for use with adults. Respondents are asked to describe how troubling particular items have been over the past four weeks. Covers both physical and emotional impact. Range 1-4. lower score is indicative of better health
Time frame: baseline and 24 weeks
Change in SF 36
The 36-Item Short Form Health Survey (SF-36) is a set of generic, coherent, and easily administered quality-of-life measures. Range 0-100. Higher score is indicative of better health.
Time frame: baseline and 24 weeks
Change in PHQ9
The PHQ-9 (Patient Health Questionnaire-9) objectifies and assesses degree of depression severity via questionnaire. It has 9 questions. Range 0-27, lower score is indicate of better health.
Time frame: baseline and 24 weeks