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| ID | Type | Description | Link |
|---|---|---|---|
| C5301005 | Other Identifier | Alias Study Number |
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Strategic decision to discontinue the study based on adjusted clinical development plan. This decision is not based on any safety concerns.
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This study is a double-blind, parallel-group, randomized study of active drug vs placebo in asthma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BHV3500 | Experimental | Zavegepant 150 mg BID |
|
| Placebo | Placebo Comparator | Matching placebo 150 mg BID |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zavegepant | Drug | 150 mg BID |
|
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
-
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Calgary | Calgary | Alberta | T2N 426 | Canada | ||
| University of Calgary |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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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.
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A total of 45 participants signed the informed consent form and were enrolled, of which 30 were screen failures and 15 participants were randomized into the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Zavegepant | Participants with mild allergic asthma, with a history of episodic wheeze and shortness of breath were administered 150 milligrams (mg) of zavegepant twice daily (BID) for 28 days. Participants were followed for up to 10 days post last dose of study treatment. |
| FG001 | Placebo | Participants with mild allergic asthma, with a history of episodic wheeze and shortness of breath were administered placebo BID for 28 days. Participants were followed for up to 10 days post last dose of study treatment. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety analysis set included all randomized participants who received at least 1 dose of study therapy.
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| ID | Title | Description |
|---|---|---|
| BG000 | Zavegepant | Participants with mild allergic asthma, with a history of episodic wheeze and shortness of breath were administered 150 milligrams (mg) of zavegepant twice daily (BID) for 28 days. Participants were followed for up to 10 days post last dose of study treatment. |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Modified Intent-to-Treat (mITT) analysis set included participants who received at least 1 dose of study therapy and provided at least 1 non-missing post-baseline LAR assessment. | Posted | Least Squares Mean | 95% Confidence Interval | Percent change | Baseline (pre-allergen challenge on Day 27) and anytime between 3 and 7 hours post-challenge on Day 27 |
|
On treatment: From start of study treatment on Day 1 up to Day 28 and Follow up: From Day 29 to Day 41
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Zavegepant (On Treatment) | Participants with mild allergic asthma, with a history of episodic wheeze and shortness of breath were administered 150 milligrams (mg) of zavegepant twice daily (BID) for 28 days. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA v24.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 9, 2021 | Feb 2, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 16, 2023 | Feb 2, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| D006967 | Hypersensitivity |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| Placebo |
| Drug |
Placebo matching active drug |
|
| 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 |
| 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 |
Participants with mild allergic asthma, with a history of episodic wheeze and shortness of breath were administered placebo BID for 28 days. Participants were followed for up to 10 days post last dose of study treatment. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Title |
|---|
| Description |
|---|
| OG000 | Zavegepant | Participants with mild allergic asthma, with a history of episodic wheeze and shortness of breath were administered 150 milligrams (mg) of zavegepant twice daily (BID) for 28 days. Participants were followed for up to 10 days post last dose of study treatment. |
| OG001 | Placebo | Participants with mild allergic asthma, with a history of episodic wheeze and shortness of breath were administered placebo BID for 28 days. Participants were followed for up to 10 days post last dose of study treatment. |
|
|
|
| Secondary | 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. | mITT analysis set included participants who received at least 1 dose of study therapy and provided at least 1 non-missing post-baseline LAR assessment. | Posted | Least Squares Mean | 95% Confidence Interval | Percent change | Baseline (pre-allergen challenge on Day 27) and anytime between 0 and 2 hours post-challenge on Day 27 |
|
|
|
|
| Secondary | 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. | mITT analysis set included participants who received at least 1 dose of study therapy and provided at least 1 non-missing post-baseline LAR assessment. | Posted | Least Squares Mean | 95% Confidence Interval | Milligrams per milliliter | From Day -15 to Day 28 |
|
|
|
|
| Secondary | 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. | The safety analysis set included all randomized participants who received at least 1 dose of study therapy. | Posted | Count of Participants | Participants | From start of treatment on Day 1 up to Day 41 |
|
|
|
| Secondary | 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. | The safety analysis set included all randomized participants who received at least 1 dose of study therapy. | Posted | Count of Participants | Participants | From start of treatment on Day 1 to Day 28 |
|
|
|
| 0 |
| 7 |
| 0 |
| 7 |
| 3 |
| 7 |
| EG001 | Placebo (On Treatment) | Participants with mild allergic asthma, with a history of episodic wheeze and shortness of breath were administered placebo BID for 28 days. | 0 | 8 | 0 | 8 | 4 | 8 |
| EG002 | Zavegepant (Follow-up) | Participants who received zavegepant during treatment phase were followed for up to 10 days post last dose of study treatment. | 0 | 7 | 0 | 7 | 0 | 7 |
| EG003 | Placebo (Follow-up) | Participants who received placebo during treatment phase were followed for up to 10 days post last dose of study treatment. | 0 | 8 | 0 | 8 | 1 | 8 |
| Diarrhoea | Gastrointestinal disorders | MedDRA v24.1 | Non-systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA v24.1 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA v24.1 | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA v24.1 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA v24.1 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v24.1 | Non-systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA v24.1 | Non-systematic Assessment |
|
| Paranasal sinus discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA v24.1 | Non-systematic Assessment |
|
| Pulmonary congestion | Respiratory, thoracic and mediastinal disorders | MedDRA v24.1 | Non-systematic Assessment |
|
| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA v24.1 | Non-systematic Assessment |
|
| COVID-19 | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA v24.1 | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D007154 | Immune System Diseases |