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

NCT ID: NCT04987944

Last Updated: 2024-07-19

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-18

Study Completion Date

2023-04-04

Brief Summary

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

Detailed Description

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Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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BHV3500

Zavegepant 150 mg BID

Group Type EXPERIMENTAL

Zavegepant

Intervention Type DRUG

150 mg BID

Placebo

Matching placebo 150 mg BID

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo matching active drug

Interventions

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Zavegepant

150 mg BID

Intervention Type DRUG

Placebo

Placebo matching active drug

Intervention Type DRUG

Other Intervention Names

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BHV3500

Eligibility Criteria

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Inclusion Criteria

* Subjects with Asthma

Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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University of Calgary

Calgary, Alberta, Canada

Site Status

University of Calgary

Calgary, Alberta, Canada

Site Status

University of Alberta Hospital

Edmonton, Alberta, Canada

Site Status

The Lung Centre- Vancouver General Hospital

Vancouver, British Columbia, Canada

Site Status

The Lung Centre-Vancouver General Hospital

Vancouver, British Columbia, Canada

Site Status

McMaster University

Hamilton, Ontario, Canada

Site Status

McMaster Universtiy

Hamilton, Ontario, Canada

Site Status

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

Québec, Quebec, Canada

Site Status

University of Saskatchewan/Royal University Hospital

Saskatoon, Saskatchewan, Canada

Site Status

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

Québec, , Canada

Site Status

Countries

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Canada

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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

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

Other Identifiers

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C5301005

Identifier Type: OTHER

Identifier Source: secondary_id

BHV3500-204

Identifier Type: -

Identifier Source: org_study_id

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