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

NCT ID: NCT04108377

Last Updated: 2023-10-24

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-21
• Study Completion Date: 2023-08-15

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 other will receive a placebo.

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.

Targeting Phosphodiesterase 4 inhibitors (PDE4) allows for examination of a mechanism potentially linking obesity and asthma as well as identification of readily available and safe options to treat hyperinsulinemic, overweight asthmatics.

It is hypothesized that obesity and hyperinsulinemia contribute to asthma by impairing β2 adrenoreceptor function and that this can be rescued the PDE4 inhibitor, roflumilast.

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Roflumilast

Roflumilast 500mcg by mouth, once daily, for 70 days (10 weeks).

Group Type: EXPERIMENTAL

Roflumilast

Intervention Type: DRUG

Roflumilast capsule

Placebo

Placebo by mouth, once daily, for 70 days (10 weeks).

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Sugar pill manufactured to mimic look of Roflumilast capsule

Interventions

Roflumilast

Roflumilast capsule

Intervention Type: DRUG

Placebo

Sugar pill manufactured to mimic look of Roflumilast capsule

Intervention Type: DRUG

Other Intervention Names

Daliresp; Placebo for Roflumilast

Eligibility 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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of California, Davis

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nicholas Kenyon, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, Davis

Locations

UC Davis

Sacramento, California, United States

Countries

United States

Related Links

https://studypages.com/s/a-study-of-the-experimental-medicine-roflumilast-for-severe-asthma-936481/

Learn more or sign up for the study here!

Other Identifiers

1406843

Identifier Type: -

Identifier Source: org_study_id