Trial of Roflumilast in Asthma Management (TRIM)
Condition: Asthma; Obesity
MeSH terms: Asthma
Intervention: Roflumilast 500 Mcg Oral Tablet; Placebo oral capsule
Intervention description: The first two weeks the participant will take one tablet every other day. If well tolerated, participant will take one tablet every day.; The first two weeks the participant will take one tablet every other day. If well tolerated, participant will take one tablet every day.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 38.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.
    

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