Status:
TERMINATED
Phosphodiesterase 4 Inhibitor, Roflumilast, and the Effects of Inhibition in Severe Asthma
Lead Sponsor:
University of California, Davis
Conditions:
Asthma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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...
Detailed Description
T2 low asthma is common in obese asthmatics. New evidence suggests that hyperinsulinemia and insulin resistance, both common in obesity, are associated with an increased risk of concurrent asthma. Ta...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
January 21 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 15 2023
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT04108377
Start Date
January 21 2019
End Date
August 15 2023
Last Update
October 24 2023
Active Locations (1)
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1
UC Davis
Sacramento, California, United States, 95816