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Trial of Roflumilast in Asthma Management (TRIM)

NCT03532490 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2022-10-06

Study results available
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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.

Conditions

Interventions

DRUG

Roflumilast 500 Mcg Oral Tablet

The first two weeks the participant will take one tablet every other day. If well tolerated, participant will take one tablet every day.

DRUG

Placebo oral capsule

The first two weeks the participant will take one tablet every other day. If well tolerated, participant will take one tablet every day.

Sponsors & Collaborators

  • American Lung Association

    collaborator OTHER

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • Johns Hopkins University

    lead OTHER

Principal Investigators

  • Anne Dixon, MD · University of Vermont

  • Robert Wise, MD · Johns Hopkins School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-03
Primary Completion
2021-07-30
Completion
2021-07-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03532490 on ClinicalTrials.gov