Trial of Roflumilast in Asthma Management (TRIM)

Johns Hopkins University

Status and phase: Completed; Phase 2

Conditions: Asthma; Obesity

Treatments: Drug: Roflumilast 500 Mcg Oral Tablet; Drug: Placebo oral capsule

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03532490

R34HL135361 (U.S. NIH Grant/Contract)

IRB00156697

Details and patient eligibility

About

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.

Full 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.

Enrollment: 38 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 forced expiratory volume at one second 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: Body Mass Index (BMI) > 30 kg/m2
• Poorly controlled asthma: Asthma Control Test (ACT) 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 Patient Health Questionnaire (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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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38 participants in 2 patient groups, including a placebo group

Roflumilast 500 mcg oral tablet

Active Comparator group

Description:

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.

Treatment:

Drug: Roflumilast 500 Mcg Oral Tablet

Placebo oral tablet

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo oral capsule