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

Stopped early · Phase 1 · Has a placebo group

Conditions studied: Asthma

In brief

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.

Key facts

Study ID

NCT04108377

Run by

University of California, Davis

People needed

5

Starts

2019-01-21

Expected to finish

2023-08-15

Last updated by the study team

2023-10-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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).

Where it is running

• UC Davis — Sacramento, California, United States

Full record on ClinicalTrials.gov

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