CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 38 enrolled
Drug / intervention
Roflumilast 500 Mcg Oral Tablet +1 moredrug
Likely dose
Roflumilast 500 Mcg Oral Tabletfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03532490
NCT03532490Phase 2Completed
CompareCT.gov

Trial of Roflumilast in Asthma Management (TRIM)

Johns Hopkins University·interventional·Posted May 22, 2018·Updated Oct 6, 2022

In Brief

A Phase 2 clinical trial evaluating Roflumilast 500 Mcg Oral Tablet and Placebo oral capsule for Asthma and Obesity. Completed, enrolled 38 participants across 7 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma, Obesity
CountriesUnited States
CollaboratorsAmerican Lung Association, National Heart, Lung, and Blood Institute (NHLBI)

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedMay 22, 2018
Enrollment StartAug 3, 2018
Primary CompletionJul 30, 2021
TodayJul 2, 2026
Enrollment to primary: 3.0 yearsPosted 8.1 years ago

Interventions

Roflumilast 500 Mcg Oral Tabletdrug

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

Placebo oral capsuledrug

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