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

Part of paid clinical trials in Sacramento, California.

Sponsor
University of California, Davis
Study ID
NCT04108377
Phase
PHASE1
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Roflumilast — DRUG
    Roflumilast capsule
  • Placebo — DRUG
    Sugar pill manufactured to mimic look of Roflumilast capsule

Study Details

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 Dates

Start date
Jan 21, 2019
Status verified
May 2023
Primary completion
Dec 11, 2022
Completion
Aug 15, 2023

Study Design

Enrollment
5 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Roflumilast
    Roflumilast 500mcg by mouth, once daily, for 70 days (10 weeks).
  • Placebo Comparator: Placebo
    Placebo by mouth, once daily, for 70 days (10 weeks).

Primary Outcome Measure

Change in Beta 2 Agonist response from Baseline [ Time Frame: 3 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
UC DavisSacramentoCalifornia95816-

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