Study Stopped
Strategic decision to discontinue the study based on adjusted clinical development plan. This decision is not based on any safety concerns.
Safety and Efficacy Active Drug vs. Placebo in Subjects With Asthma
A Phase 1b, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate Safety and Efficacy of Oral Zavegepant in Subjects With Mild Allergic Asthma
2 other identifiers
interventional
45
1 country
10
Brief Summary
This study is a double-blind, parallel-group, randomized study of active drug vs placebo in asthma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 asthma
Started Oct 2021
Typical duration for phase_1 asthma
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 26, 2021
CompletedFirst Posted
Study publicly available on registry
August 3, 2021
CompletedStudy Start
First participant enrolled
October 18, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 29, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
April 4, 2023
CompletedResults Posted
Study results publicly available
July 19, 2024
CompletedJuly 19, 2024
February 1, 2024
1.4 years
July 26, 2021
February 2, 2024
February 2, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Maximum Percentage Decrease From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Any Time Between 3 and 7 Hours Post-Allergen Challenge
Allergen inhalation challenge was performed on Day 27 and FEV1 was measured using spirometry prior to the challenge and between 3 to 7 hours post allergen challenge to assess late asthmatic response (LAR). FEV1 was the maximal volume of air exhaled in 1 second of a forced expiration from a position of full inspiration. The maximum percentage decrease was the difference between the baseline (pre-allergen challenge) FEV1 on Day 27 and lowest FEV1 between hours 3 and 7 on Day 27 divided by the baseline value from Day 27. Analysis was performed using analysis of covariance (ANCOVA) model with treatment as main effect and baseline FEV1 as covariate.
Baseline (pre-allergen challenge on Day 27) and anytime between 3 and 7 hours post-challenge on Day 27
Secondary Outcomes (4)
Maximum Percentage Decrease From Baseline in FEV1 at Any Time Between 0 and 2 Hours Post-Allergen Challenge
Baseline (pre-allergen challenge on Day 27) and anytime between 0 and 2 hours post-challenge on Day 27
Change in Methacholine PC20 From Pre-Allergen Challenge to Post-Allergen Challenge
From Day -15 to Day 28
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
From start of treatment on Day 1 up to Day 41
Number of Participants With Clinically Significant Laboratory Test Abnormalities on Treatment
From start of treatment on Day 1 to Day 28
Study Arms (2)
BHV3500
EXPERIMENTALZavegepant 150 mg BID
Placebo
PLACEBO COMPARATORMatching placebo 150 mg BID
Interventions
Eligibility Criteria
You may qualify if:
- Subjects with Asthma
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (10)
University of Calgary
Calgary, Alberta, T2N 426, Canada
University of Calgary
Calgary, Alberta, T2N 4Z6, Canada
University of Alberta Hospital
Edmonton, Alberta, T6G 2B7, Canada
The Lung Centre- Vancouver General Hospital
Vancouver, British Columbia, V5Z 1M9, Canada
The Lung Centre-Vancouver General Hospital
Vancouver, British Columbia, V5Z 1M9, Canada
McMaster University
Hamilton, Ontario, L8S 4K1, Canada
McMaster Universtiy
Hamilton, Ontario, L8S 4K1, Canada
Institut universitaire en cardiologie et pneumologie de Quebec-Universite Laval-(IUCPQ-UL)
Québec, Quebec, G1V 4G5, Canada
University of Saskatchewan/Royal University Hospital
Saskatoon, Saskatchewan, S7N 0W8, Canada
Institut universitaire en cardiologie et pneumologie de Quebec-Universite Laval-(IUCPQ-UL)
Québec, G1V 4G5, Canada
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 26, 2021
First Posted
August 3, 2021
Study Start
October 18, 2021
Primary Completion
March 29, 2023
Study Completion
April 4, 2023
Last Updated
July 19, 2024
Results First Posted
July 19, 2024
Record last verified: 2024-02
Data Sharing
- IPD Sharing
- Will not share
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.