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

NCT04108377 | Terminated Phase 1 FDA Drug

• 1 other identifier: 1406843
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma

Keywords

Hyperinsulinemia; Phosphodiesterase 4 Inhibitor

Outcome Measures

Primary Outcomes (1)

• Change in Beta 2 Agonist response from Baseline

  Determine whether β2 receptor responsiveness is improved in response to albuterol in Group 1 (Roflumilast) patients compared to Group 2 (Placebo) patients at the study entry.

  3 months

Secondary Outcomes (2)

• Exhaled nitric oxide

  3 months

• Asthma Control Test score

  3 months

Study Arms (2)

Roflumilast

EXPERIMENTAL

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

Drug: Roflumilast

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Roflumilast DRUG

Roflumilast capsule

Also known as: Daliresp

Roflumilast

Placebo DRUG

Sugar pill manufactured to mimic look of Roflumilast capsule

Also known as: Placebo for Roflumilast

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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).

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

UC Davis

Sacramento, California, 95816, United States

Location

Related Links

• Learn more or sign up for the study here!

MeSH Terms

Conditions

Asthma; Hyperinsulinism

Interventions

Roflumilast

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Nicholas Kenyon, MD

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2019
• First Posted: September 30, 2019
• Study Start: January 21, 2019
• Primary Completion: December 11, 2022
• Study Completion: August 15, 2023
• Last Updated: October 24, 2023

Record last verified: 2023-05

Locations

US (1)