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Phosphodiesterase 4 Inhibitor

Roflumilast for Asthma

Phase 1
Waitlist Available
Led By Nicholas Kenyon, MD
Research Sponsored by University of California, Davis
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Exhaled Nitric oxide (FeNO)<30 ppb
Peripheral blood eosinophil count < 300 (x10-6/ul)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights

Study Summary

This trial will test whether or not roflumilast can help asthmatics who are obese and have low levels of a certain receptor respond better to β2 adrenoreceptor agonists.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Beta 2 Agonist response from Baseline
Secondary outcome measures
Asthma Control Test score
Exhaled nitric oxide

Side effects data

From 2015 Phase 4 trial • 12 Patients • NCT03073798
8%
Pulmonary Exacerbation
100%
80%
60%
40%
20%
0%
Study treatment Arm
All Participants

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: RoflumilastExperimental Treatment1 Intervention
Roflumilast 500mcg by mouth, once daily, for 70 days (10 weeks).
Group II: PlaceboPlacebo Group1 Intervention
Placebo by mouth, once daily, for 70 days (10 weeks).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Roflumilast
2013
Completed Phase 4
~9010

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

University of California, DavisLead Sponsor
908 Previous Clinical Trials
4,704,110 Total Patients Enrolled
7 Trials studying Asthma
350 Patients Enrolled for Asthma
Nicholas Kenyon, MDPrincipal InvestigatorUniversity of California, Davis
2 Previous Clinical Trials
50 Total Patients Enrolled
2 Trials studying Asthma
50 Patients Enrolled for Asthma

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What potential risks might patients taking Roflumilast be exposed to?

"The safety of Roflumilast is rated a 1 on the scale due to its Phase 1 status, meaning there are limited studies that attest to both efficacy and safety."

Answered by AI

What is the maximum number of participants being enrolled in this research endeavor?

"Affirmative. Clinicaltrials.gov's publicly accessible data implies that this medical investigation is currently in the process of recruitment, which began on January 21st 2019 and was most recently amended on January 31st 2022. Approximately 24 patients must be drawn from a single trial site for participation."

Answered by AI

Are there currently open opportunities for volunteers to join this study?

"According to the clinicaltrials.gov website, this medical study is in active recruitment mode and has been since it was first posted on January 21st 2019 with edits occurring as recently as January 31st 2022."

Answered by AI

What other researches have been conducted to assess the efficacy of Roflumilast?

"Presently, there are 9 ongoing clinical trials exploring Roflumilast with 3 at the Phase 3 level. Although most of these studies occur in Shibeen Elkom and Menoufia, there are 121 different research facilities involved."

Answered by AI
~1 spots leftby Mar 2025