Trial of Roflumilast in Asthma Management (TRIM)
Age: 18 years - 66+
Healthy Subjects: No
Study Phase: Phase 2
Recruitment Status: Recruiting
Start Date: August 03, 2018
End Date: April 01, 2020
- 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
- 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)
- 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