Trial of Roflumilast in Asthma Management (TRIM)

• Sponsor: Johns Hopkins University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03532490
• Collaborator: American Lung Association (Other), National Heart, Lung, and Blood Institute (NHLBI) (NIH)
• Enrollment: 38
• Locations: 7
• Arms: 2
• Actual Duration (Months): 35.9
• Patients Per Site: 5.4
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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 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.

Study Design

• Study Type: Interventional
• Actual 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: Aug 3, 2018
• Actual Primary Completion Date: Jul 30, 2021
• Actual Study Completion Date: Jul 30, 2021

Arms and Interventions

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 Names: 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.

Outcome Measures

Primary Outcome Measures

1. Asthma Control Test [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 [24 weeks]

   Changes in weight will be monitored for the duration of the study.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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 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: 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 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 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama Lung Health Center	Birmingham	Alabama	United States	35294
2	University of Arizona	Tucson	Arizona	United States	85724
3	University of Illinois at Chicago, Breathe Chicago Center	Chicago	Illinois	United States	60608
4	Northwestern University Feinberg School of Medicine	Chicago	Illinois	United States	60611
5	Mount Sinai Icahn School of Medicine	New York	New York	United States	10029
6	Duke University	Durham	North Carolina	United States	27705
7	University of Vermont	Colchester	Vermont	United States	05446

Sponsors and Collaborators

• Johns Hopkins University
• American Lung Association
• National Heart, Lung, and Blood Institute (NHLBI)

Investigators

• Principal Investigator: Anne Dixon, MD, University of Vermont
• Principal Investigator: Robert Wise, MD, Johns Hopkins School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Johns Hopkins University
• ClinicalTrials.gov Identifier: NCT03532490
• Other Study ID Numbers: IRB00156697; R34HL135361
• First Posted: May 22, 2018
• Last Update Posted: Aug 12, 2021
• Last Verified: Aug 1, 2021

• 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: Asthma

Study Results

No Results Posted as of Aug 12, 2021