Trial of Roflumilast in Asthma Management (TRIM)



Status:Recruiting
Conditions:Asthma, Obesity Weight Loss
Therapuetic Areas:Endocrinology, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - Any
Updated:11/4/2018
Start Date:August 3, 2018
End Date:April 2020
Contact:Gem Roy, MD
Email:groy2@jhu.edu
Phone:4432875796

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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.

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.

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
We found this trial at
5
sites
303 E Chicago Ave
Chicago, Illinois 60611
(312) 503-8194
Phone: 312-926-0975
Northwestern University Feinberg School of Medicine Northwestern University Feinberg School of Medicine, founded in 1859,...
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Durham, North Carolina 27710
(919) 684-8111
Phone: 919-479-0861
Duke University Younger than most other prestigious U.S. research universities, Duke University consistently ranks among...
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Durham, NC
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Colchester, Vermont 05446
Phone: 802-847-8839
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Colchester, VT
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1 Gustave L. Levy Place
New York, New York 10029
Phone: 212-241-9538
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New York, NY
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Tucson, Arizona 85721
(520) 621-2211
Phone: 520-626-4200
University of Arizona The University of Arizona is a premier, public research university. Established in...
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