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

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

Study Overview

• Status: Terminated
• Conditions: Asthma
• Intervention / Treatment: Drug: Zavegepant; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Phase 1

Contacts and Locations

Study Locations

• Canada
  • Quebec, Canada, G1V 4G5
    • Institut universitaire en cardiologie et pneumologie de Quebec-Universite Laval-(IUCPQ-UL)
  • Alberta
    • Calgary, Alberta, Canada, T2N 4Z6
      • University of Calgary
    • Calgary, Alberta, Canada, T2N 426
      • University of Calgary
    • Edmonton, Alberta, Canada, T6G 2B7
      • University of Alberta Hospital
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 1M9
      • The Lung Centre-Vancouver General Hospital
    • Vancouver, British Columbia, Canada, V5Z 1M9
      • The Lung Centre- Vancouver General Hospital
  • Ontario
    • Hamilton, Ontario, Canada, L8S 4K1
      • McMaster University
    • Hamilton, Ontario, Canada, L8S 4K1
      • McMaster Universtiy
  • Quebec
    • Québec, Quebec, Canada, G1V 4G5
      • Institut universitaire en cardiologie et pneumologie de Quebec-Universite Laval-(IUCPQ-UL)
  • Saskatchewan
    • Saskatoon, Saskatchewan, Canada, S7N 0W8
      • University of Saskatchewan/Royal University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Subjects with Asthma

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BHV3500; Zavegepant 150 mg BID	Drug: Zavegepant; 150 mg BID; Other Names: BHV3500
Placebo Comparator: Placebo; Matching placebo 150 mg BID	Drug: Placebo; Placebo matching active drug

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum Percentage Decrease From Baseline in FEV1 at Any Time Between 0 and 2 Hours Post-Allergen Challenge	Allergen inhalation challenge was performed on Day 27 and FEV1 was measured using spirometry prior to the challenge and between 0 to 2 hours post allergen challenge to assess early asthmatic response (EAR). 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 0 and 2 on Day 27 divided by the baseline value from Day 27. Analysis was performed using ANCOVA model with treatment as main effect and baseline FEV1 as covariate.	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	Airway hyperresponsiveness was assessed using methacholine provocation concentration causing a 20% decline in FEV1 (PC20). Change in PC20 from pre-allergen to post-allergen = PC20 in post-allergen challenge minus PC20 in pre-allergen challenge. Shift in PC20 was calculated as post-allergen challenge minus pre-allergen challenge (Day 28 minus Day 26), and baseline shift in PC20 was calculated as post-allergen challenge minus pre-allergen challenge (Day -13 minus Day-15). Analysis was performed using ANCOVA model with treatment as main effect and baseline shift as covariate.	From Day -15 to Day 28
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)	An adverse event (AE) was any untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered an investigational (medicinal) product and that did not necessarily have a causal relationship with this treatment. An SAE was defined as any adverse event that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; life-threatening; resulted in persistent or significant disability/incapacity; congenital anomaly/birth defect or other important medical events. TEAEs were events with onset dates on or after the start of the study drug.	From start of treatment on Day 1 up to Day 41
Number of Participants With Clinically Significant Laboratory Test Abnormalities on Treatment	The following laboratory parameters were assessed: hematology (eosinophils, hemoglobin, leukocytes, lymphocytes, neutrophils and platelets), chemistry (Albumin, alanine aminotransferase [ALT], alkaline phosphatase [ALP], aspartate aminotransferase [AST], bicarbonate, bilirubin, calcium, cholesterol, creatine kinase, creatinine, glucose, low-density lipoproteins [LDL], lactate dehydrogenase, potassium, sodium, triglycerides) and urinalysis (urine glucose and urine protein). Clinically significant laboratory test abnormalities were Grade 3 (severe) to Grade 4 (potentially life-threatening) laboratory test results graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 except for glucose, LDL cholesterol, uric acid and urinalysis which were graded using Division of Aids (DAIDS) Version 2.1 where, Grade 3=severe and Grade 4=potentially life-threatening. Number of participants with clinically significant abnormalities in any laboratory parameter is presented.	From start of treatment on Day 1 to Day 28

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): October 18, 2021
• Primary Completion (Actual): March 29, 2023
• Study Completion (Actual): April 4, 2023

Study Registration Dates

• First Submitted: July 26, 2021
• First Submitted That Met QC Criteria: July 26, 2021
• First Posted (Actual): August 3, 2021

Study Record Updates

• Last Update Posted (Actual): July 19, 2024
• Last Update Submitted That Met QC Criteria: February 2, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Asthma; Allergy
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: BHV3500-204; C5301005 (Other Identifier: Alias Study Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No