Clinical trial NCT03532490: Trial of Roflumilast in Asthma Management (TRIM)
Official title: Trial of Roflumilast in Asthma Management (TRIM)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Asthma
Obesity
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: American Lung Association
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2018-05-22
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Asthma Control Test Score
timeFrame: Baseline and 24 weeks
Secondary outcomes:
measure: Change in Weight
timeFrame: Baseline and 24 weeks
measure: Change in Asthma Symptom Utility Index (ASUI)
timeFrame: baseline and 24 weeks
measure: Change in Gastrointestinal Symptom Rating Scale (GSRS)
timeFrame: Baseline and 24 weeks
measure: Change in Generalized Anxiety Disease (GAD-7)
timeFrame: baseline and 24 weeks
measure: Change in Marks Asthma Quality of Life Questionnaire
timeFrame: baseline and 24 weeks
measure: Change in SF 36
timeFrame: baseline and 24 weeks
measure: Change in PHQ9
timeFrame: baseline and 24 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama Lung Health Center
state: Alabama
city: Tucson
country: United States
facility: University of Arizona
state: Arizona
city: Chicago
country: United States
facility: University of Illinois at Chicago, Breathe Chicago Center
state: Illinois
city: Chicago
country: United States
facility: Northwestern University Feinberg School of Medicine
state: Illinois
city: New York
country: United States
facility: Mount Sinai Icahn School of Medicine
state: New York
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Colchester
country: United States
facility: University of Vermont
state: Vermont
Study officials:
affiliation: University of Vermont
name: Anne Dixon, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Johns Hopkins School of Medicine
name: Robert Wise, MD
role: PRINCIPAL_INVESTIGATOR
References: