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

Primary Purpose

Asthma

Status

Terminated

Phase

Phase 1

Locations

Canada

Study Type

Interventional

Intervention

Zavegepant

Placebo

About this trial

This is an interventional treatment trial for Asthma focused on measuring Allergy, Asthma

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Subjects with Asthma

Exclusion Criteria:

Sites / Locations

University of Calgary
University of Calgary
University of Alberta Hospital
The Lung Centre- Vancouver General Hospital
The Lung Centre-Vancouver General Hospital
McMaster University
McMaster Universtiy
Institut universitaire en cardiologie et pneumologie de Quebec-Universite Laval-(IUCPQ-UL)
University of Saskatchewan/Royal University Hospital
Institut universitaire en cardiologie et pneumologie de Quebec-Universite Laval-(IUCPQ-UL)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

BHV3500

Placebo

Arm Description

Zavegepant 150 mg BID

Matching placebo 150 mg BID

Outcomes

Primary Outcome Measures

Allergen induced late asthmatic response (LAR)

FEV1

Secondary Outcome Measures

Full Information

NCT ID

NCT04987944

First Posted

July 26, 2021

Last Updated

July 14, 2023

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT04987944

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Terminated

Why Stopped

Strategic decision to discontinue the study based on adjusted clinical development plan. This decision is not based on any safety concerns.

Study Start Date

October 18, 2021 (Actual)

Primary Completion Date

March 29, 2023 (Actual)

Study Completion Date

April 4, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pfizer

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Asthma

Keywords

Allergy, Asthma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Sequential Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

15 (Actual)

8. Arms, Groups, and Interventions

Arm Title

BHV3500

Arm Type

Experimental

Arm Description

Zavegepant 150 mg BID

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Matching placebo 150 mg BID

Intervention Type

Drug

Intervention Name(s)

Zavegepant

Other Intervention Name(s)

BHV3500

Intervention Description

150 mg BID

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo matching active drug

Primary Outcome Measure Information:

Title

Allergen induced late asthmatic response (LAR)

Description

FEV1

Time Frame

3-7 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subjects with Asthma Exclusion Criteria: -

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pfizer CT.gov Call Center

Organizational Affiliation

Pfizer

Official's Role

Study Director

Facility Information:

Facility Name

University of Calgary

City

Calgary

State/Province

Alberta

ZIP/Postal Code

T2N 426

Country

Canada

Facility Name

University of Calgary

City

Calgary

State/Province

Alberta

ZIP/Postal Code

T2N 4Z6

Country

Canada

Facility Name

University of Alberta Hospital

City

Edmonton

State/Province

Alberta

ZIP/Postal Code

T6G 2B7

Country

Canada

Facility Name

The Lung Centre- Vancouver General Hospital

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V5Z 1M9

Country

Canada

Facility Name

The Lung Centre-Vancouver General Hospital

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V5Z 1M9

Country

Canada

Facility Name

McMaster University

City

Hamilton

State/Province

Ontario

ZIP/Postal Code

L8S 4K1

Country

Canada

Facility Name

McMaster Universtiy

City

Hamilton

State/Province

Ontario

ZIP/Postal Code

L8S 4K1

Country

Canada

Facility Name

Institut universitaire en cardiologie et pneumologie de Quebec-Universite Laval-(IUCPQ-UL)

City

Québec

State/Province

Quebec

ZIP/Postal Code

G1V 4G5

Country

Canada

Facility Name

University of Saskatchewan/Royal University Hospital

City

Saskatoon

State/Province

Saskatchewan

ZIP/Postal Code

S7N 0W8

Country

Canada

Facility Name

Institut universitaire en cardiologie et pneumologie de Quebec-Universite Laval-(IUCPQ-UL)

City

Quebec

ZIP/Postal Code

G1V 4G5

Country

Canada

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

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.

Links:

URL

https://pmiform.com/clinical-trial-info-request?StudyID=BHV3500-204

Description

To obtain contact information for a study center near you, click here.

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

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