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NCT04987944 Clinical Trial

Safety and Efficacy Active Drug vs. Placebo in Subjects With Asthma

Asthma Clinical Trial

Official title:
A Phase 1b, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate Safety and Efficacy of Oral Zavegepant in Subjects With Mild Allergic Asthma

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT04987944
Other study ID # BHV3500-204
Secondary ID C5301005
Status Terminated
Phase Phase 1
First received
Last updated
Start date October 18, 2021
Est. completion date April 4, 2023

Study information
Verified date July 2023
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study is a double-blind, parallel-group, randomized study of active drug vs placebo in asthma.

Recruitment information / eligibility
Status Terminated
Enrollment 15
Est. completion date April 4, 2023
Est. primary completion date March 29, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Subjects with Asthma Exclusion Criteria: -

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Zavegepant
150 mg BID
• Placebo
Placebo matching active drug

Locations
Country Name City State
Canada University of Calgary Calgary Alberta
Canada University of Calgary Calgary Alberta
Canada University of Alberta Hospital Edmonton Alberta
Canada McMaster University Hamilton Ontario
Canada McMaster Universtiy Hamilton Ontario
Canada Institut universitaire en cardiologie et pneumologie de Quebec-Universite Laval-(IUCPQ-UL) Quebec
Canada Institut universitaire en cardiologie et pneumologie de Quebec-Universite Laval-(IUCPQ-UL) Québec Quebec
Canada University of Saskatchewan/Royal University Hospital Saskatoon Saskatchewan
Canada The Lung Centre- Vancouver General Hospital Vancouver British Columbia
Canada The Lung Centre-Vancouver General Hospital Vancouver British Columbia

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary Allergen induced late asthmatic response (LAR) FEV1 3-7 hours
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