Trial of Roflumilast in Asthma Management (TRIM)

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Johns Hopkins University
Study ID
NCT03532490
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Roflumilast 500 Mcg Oral Tablet — DRUG
    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 capsule — DRUG
    The first two weeks the participant will take one tablet every other day. If well tolerated, participant will take one tablet every day.

Study Details

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.

Key Dates

Start date
Aug 3, 2018
Status verified
Sep 2022
Primary completion
Jul 30, 2021
Completion
Jul 30, 2021

Study Design

Enrollment
38 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Roflumilast 500 mcg oral tablet
    500 mcg roflumilast oral tablets will be taken every other day for the first two weeks. If participant tolerates the drug, the tablet will be taken once daily.
  • Placebo Comparator: Placebo oral tablet
    500 mcg placebo oral tablets will be taken every other day for the first two weeks. If participant tolerates the drug, the tablet will be taken once daily.

Primary Outcome Measure

Change in Asthma Control Test Score [ Time Frame: Baseline and 24 weeks ]

Locations (7)

FacilityCityStateZIPSite coordinators
University of Alabama Lung Health CenterBirminghamAlabama35294-
University of ArizonaTucsonArizona85724-
Northwestern University Feinberg School of MedicineChicagoIllinois60611-
University of Illinois at Chicago, Breathe Chicago CenterChicagoIllinois60608-
Mount Sinai Icahn School of MedicineNew YorkNew York10029-
Duke UniversityDurhamNorth Carolina27705-
University of VermontColchesterVermont05446-

Find similar trials in Birmingham, AL

By condition
AsthmaObesity / overweight
By specialty
PulmonologyLung diseaseEndocrinologyMetabolic healthWeight loss
By research site
University of Alabama Lung Health Center· Birmingham, ALUniversity of Arizona· Tucson, AZNorthwestern University Feinberg School of Medicine· Chicago, ILUniversity of Illinois at Chicago, Breathe Chicago Center· Chicago, ILMount Sinai Icahn School of Medicine· New York, NYDuke University· Durham, NC

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