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Trial of Roflumilast in Asthma Management (TRIM) (TRIM)

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ClinicalTrials.gov Identifier: NCT03532490
Recruitment Status : Recruiting
First Posted : May 22, 2018
Last Update Posted : November 2, 2018
Sponsor:
Collaborators:
American Lung Association
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Johns Hopkins University

Brief 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.


Condition or disease Intervention/treatment Phase
Asthma Obesity Drug: Roflumilast 500 Mcg Oral Tablet Drug: Placebo oral capsule Phase 2

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 five 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, and the University of Vermont. Johns Hopkins University will be the Data Coordinating Center (DCC) for the trial.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Trial of Roflumilast in Asthma Management (TRIM)
Actual Study Start Date : August 3, 2018
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
Drug Information available for: Roflumilast

Arm Intervention/treatment
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.
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.
Other Name: Daliresp

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.
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.




Primary Outcome Measures :
  1. Asthma Control Test [ Time Frame: 24 weeks ]

    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.



Secondary Outcome Measures :
  1. Weight changes [ Time Frame: 24 weeks ]
    Changes in weight will be monitored for the duration of the study.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Physician diagnosis of asthma on regular prescribed controller therapy for at least 3 months
  • Current or previous (within five years) evidence of at least a 12% increase in FEV1 after inhaling 2-4 puffs of albuterol or a positive methacholine challenge
  • Age: ≥18 years of age
  • Obese: BMI > 30 kg/m2
  • Poorly controlled asthma: Asthma Control Test 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 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 10 or greater on the depression questions of the 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)
  • Pregnancy/lactation
  • Females of childbearing age who do not agree to practice an adequate birth control method (abstinence, combination barrier and spermicide, or hormonal) for the duration of the study.
  • Greater than 20 pack year smoking history, or smoking within the last 6 months.
  • History of bariatric surgery
  • Drugs metabolized by cytochrome P450 (rifampicin, phenobarbital, carbamazepine, phenytoin, erythromycin, ketoconazole, cimetidine, fluvoxamine, enoxacin, oral contraceptives containing ethinyl estradiol with gestodene ).
  • Currently on roflumilast or theophylline (patient may wash out of these medications for 4 weeks prior to visit 1)
  • Intention to move out of area within the next 6 months

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03532490


Contacts
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Contact: Gem Roy, MD 4432875796 groy2@jhu.edu
Contact: Heather Hazucha, MPH 4105020585 hhazuch1@jhu.edu

Locations
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United States, Arizona
University of Arizona Active, not recruiting
Tucson, Arizona, United States, 85724
United States, Illinois
Northwestern University Feinberg School of Medicine Active, not recruiting
Chicago, Illinois, United States, 60611
United States, New York
Mount Sinai Icahn School of Medicine Active, not recruiting
New York, New York, United States, 10029
United States, North Carolina
Duke University Recruiting
Durham, North Carolina, United States, 27705
Contact: Cathy Foss, BS    919-479-0861    catherine.foss@duke.edu   
United States, Vermont
University of Vermont Recruiting
Colchester, Vermont, United States, 05446
Contact: Kathy Meehan    802-847-8839    kathy.meehan@uvmhealth.org   
Sponsors and Collaborators
Johns Hopkins University
American Lung Association
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Anne Dixon, MD University of Vermont
Principal Investigator: Robert Wise, MD Johns Hopkins School of Medicine

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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT03532490     History of Changes
Other Study ID Numbers: IRB00156697
R34HL135361 ( U.S. NIH Grant/Contract )
First Posted: May 22, 2018    Key Record Dates
Last Update Posted: November 2, 2018
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases