Phosphodiesterase 4 Inhibitor, Roflumilast, and the Effects of Inhibition in Severe Asthma

• Status: Recruiting
• Trial end date: 2022-03-01
• Target enrollment: 0
• Participant gender: All

Summary

This study evaluates the effects of roflumilast on restoring response β2 adrenoreceptor agonists in low T2, obese asthmatics. One group of participants will receive roflumilast for 3 months, while the other will receive a placebo.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of California, Davis
• Treatments: Phosphodiesterase 4 Inhibitors

Criteria

Inclusion Criteria:

• Have a physician diagnosis of asthma.

• Require treatment with moderate to high-dose >2500mcg/day of fluticasone or equivalent, or use of oral steroids

Also two of the following:

• Requirement for additional daily treatment with other controller medication

• Daily Asthma symptoms

• Forced Expiratory Volume / Forced Vital Capacity (FEV1/FVC) < 70% and FEV1< 80% predicted

• ≥1 urgent care visits/year

• ≥3 oral steroid bursts/year

• Near-fatal asthma event.

• Exhaled Nitric oxide (FeNO)<30 ppb

• Peripheral blood eosinophil count < 300 (x10-6/ul)

• Obesity, BMI≥30

Exclusion Criteria:

• Less than 18 years of age

• baseline FEV1 <30% predicted

• pregnant or nursing women

• current smokers or subject with >20 pack year history

• any history of intolerance of, or reaction to, Roflumilast.

• Prisoners

• Patients with liver disease

• Subjects with Hepatic impairment (contraindicated in moderate-to-severe liver impairment: Child-Pugh Score Class B/C) for example.

• Patients with clinically significant psychiatric history (i.e., suicidality, etc.) and psychiatric illness

• Patients using strong CYP 450 enzyme inducers (e.g., rifampicin, phenobarbital, carbamazepine, phenytoin).