Trial of Roflumilast in Asthma Management (TRIM)

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 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