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Trial of Roflumilast in Asthma Management (TRIM) | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Trial of Roflumilast in Asthma Management (TRIM)

NCT03532490•Johns Hopkins University

Summary

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.

Detailed Description

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Physician diagnosis of asthma on regular prescribed controller therapy for at least 3 months
•Previous (within five years) evidence of at least a 12% increase in forced expiratory volume at one second FEV1 after inhaling 2-4 puffs of albuterol or a positive methacholine challenge or patient reported history of improvement of asthma exacerbation after a course of systemic or inhaled corticosteroids
•Age: ≥18 years of age
•Obese: Body Mass Index (BMI) \> 30 kg/m2
•Poorly controlled asthma: Asthma Control Test (ACT) Score \< 20, or use of rescue inhaler, on an average of\> 2 uses/week for preceding month, or nocturnal asthma awakening, on an average of 1 or more times / week in preceding month, or emergency department (ED)/hospital visit or prednisone course for asthma in past six months.
•Ability and willingness to provide informed consent

Exclusion Criteria

•Participation in an investigational study within the past 4 weeks
•Physician diagnosis of chronic obstructive pulmonary disease
•Any condition that puts the participant at risk from weight loss as judged by the site physician
•Liver cirrhosis
•Major psychiatric disorders such as generalized anxiety disorder, major depressive disorder, history of suicidal ideation/ attempt, panic disorder, post-traumatic stress disorder, schizophrenia, schizoaffective, substance abuse or other disorders that in the opinion of the study physician that would affect study participation
•\> 0 time use of illicit drugs in the past 12 months
•\> 0 time use of cannabis in the past 12 months
•Uncontrolled depression as defined by a score of 15 or greater on the depression questions of the Patient Health Questionnaire (PHQ-9)
•Suicidal ideation (a score of greater than 0 on Question 9 on the PHQ-9)
•Uncontrolled anxiety as defined by a score of 10 or greater on the anxiety questions of the Generalized Anxiety Disorder 7-item (GAD-7)
+7 more criteria

Locations (7)

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

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

Key Dates

Start Date

August 3, 2018

Primary Completion Date

July 30, 2021

Completion Date

July 30, 2021

Last Updated

October 6, 2022

Enrollment

ACTUAL participants

Conditions

AsthmaObesity

Interventions

Roflumilast 500 Mcg Oral Tablet

DRUG

Placebo oral capsule

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 6, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Trial of Roflumilast in Asthma Management (TRIM)

Inclusion Criteria

Exclusion Criteria

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