Trial of Roflumilast in Asthma Management (TRIM)

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