Trial Outcomes & Findings for Safety and Efficacy Active Drug vs. Placebo in Subjects With Asthma (NCT NCT04987944)
NCT ID: NCT04987944
Last Updated: 2024-07-19
Results Overview
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.
TERMINATED
PHASE1
45 participants
Baseline (pre-allergen challenge on Day 27) and anytime between 3 and 7 hours post-challenge on Day 27
2024-07-19
Participant Flow
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.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
8
|
|
Overall Study
COMPLETED
|
7
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Safety and Efficacy Active Drug vs. Placebo in Subjects With Asthma
Baseline characteristics by cohort
| Measure |
Zavegepant
n=7 Participants
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.
|
Placebo
n=8 Participants
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.
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
36.7 Years
STANDARD_DEVIATION 14.40 • n=5 Participants
|
29.3 Years
STANDARD_DEVIATION 11.06 • n=7 Participants
|
32.7 Years
STANDARD_DEVIATION 12.84 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (pre-allergen challenge on Day 27) and anytime between 3 and 7 hours post-challenge on Day 27Population: 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.
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.
Outcome measures
| Measure |
Zavegepant
n=7 Participants
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.
|
Placebo
n=6 Participants
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.
|
|---|---|---|
|
Maximum Percentage Decrease From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Any Time Between 3 and 7 Hours Post-Allergen Challenge
|
19.7 Percent change
Interval 9.9 to 29.5
|
29.5 Percent change
Interval 18.8 to 40.1
|
SECONDARY outcome
Timeframe: Baseline (pre-allergen challenge on Day 27) and anytime between 0 and 2 hours post-challenge on Day 27Population: 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.
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.
Outcome measures
| Measure |
Zavegepant
n=7 Participants
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.
|
Placebo
n=6 Participants
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.
|
|---|---|---|
|
Maximum Percentage Decrease From Baseline in FEV1 at Any Time Between 0 and 2 Hours Post-Allergen Challenge
|
30.5 Percent change
Interval 20.1 to 40.8
|
34.4 Percent change
Interval 23.2 to 45.5
|
SECONDARY outcome
Timeframe: From Day -15 to Day 28Population: 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.
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.
Outcome measures
| Measure |
Zavegepant
n=7 Participants
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.
|
Placebo
n=6 Participants
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.
|
|---|---|---|
|
Change in Methacholine PC20 From Pre-Allergen Challenge to Post-Allergen Challenge
|
0.165 Milligrams per milliliter
Interval -0.192 to 0.521
|
-0.259 Milligrams per milliliter
Interval -0.671 to 0.154
|
SECONDARY outcome
Timeframe: From start of treatment on Day 1 up to Day 41Population: The safety analysis set included all randomized participants who received at least 1 dose of study therapy.
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.
Outcome measures
| Measure |
Zavegepant
n=7 Participants
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.
|
Placebo
n=8 Participants
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.
|
|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
TESAEs
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
TEAEs
|
3 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: From start of treatment on Day 1 to Day 28Population: The safety analysis set included all randomized participants who received at least 1 dose of study therapy.
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.
Outcome measures
| Measure |
Zavegepant
n=7 Participants
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.
|
Placebo
n=8 Participants
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.
|
|---|---|---|
|
Number of Participants With Clinically Significant Laboratory Test Abnormalities on Treatment
|
0 Participants
|
0 Participants
|
Adverse Events
Zavegepant (On Treatment)
Placebo (On Treatment)
Zavegepant (Follow-up)
Placebo (Follow-up)
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Zavegepant (On Treatment)
n=7 participants at risk
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.
|
Placebo (On Treatment)
n=8 participants at risk
Participants with mild allergic asthma, with a history of episodic wheeze and shortness of breath were administered placebo BID for 28 days.
|
Zavegepant (Follow-up)
n=7 participants at risk
Participants who received zavegepant during treatment phase were followed for up to 10 days post last dose of study treatment.
|
Placebo (Follow-up)
n=8 participants at risk
Participants who received placebo during treatment phase were followed for up to 10 days post last dose of study treatment.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain upper
|
28.6%
2/7 • On treatment: From start of study treatment on Day 1 up to Day 28 and Follow up: From Day 29 to Day 41
|
0.00%
0/8 • On treatment: From start of study treatment on Day 1 up to Day 28 and Follow up: From Day 29 to Day 41
|
0.00%
0/7 • On treatment: From start of study treatment on Day 1 up to Day 28 and Follow up: From Day 29 to Day 41
|
0.00%
0/8 • On treatment: From start of study treatment on Day 1 up to Day 28 and Follow up: From Day 29 to Day 41
|
|
Gastrointestinal disorders
Diarrhoea
|
14.3%
1/7 • On treatment: From start of study treatment on Day 1 up to Day 28 and Follow up: From Day 29 to Day 41
|
12.5%
1/8 • On treatment: From start of study treatment on Day 1 up to Day 28 and Follow up: From Day 29 to Day 41
|
0.00%
0/7 • On treatment: From start of study treatment on Day 1 up to Day 28 and Follow up: From Day 29 to Day 41
|
0.00%
0/8 • On treatment: From start of study treatment on Day 1 up to Day 28 and Follow up: From Day 29 to Day 41
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/7 • On treatment: From start of study treatment on Day 1 up to Day 28 and Follow up: From Day 29 to Day 41
|
12.5%
1/8 • On treatment: From start of study treatment on Day 1 up to Day 28 and Follow up: From Day 29 to Day 41
|
0.00%
0/7 • On treatment: From start of study treatment on Day 1 up to Day 28 and Follow up: From Day 29 to Day 41
|
0.00%
0/8 • On treatment: From start of study treatment on Day 1 up to Day 28 and Follow up: From Day 29 to Day 41
|
|
General disorders
Pyrexia
|
14.3%
1/7 • On treatment: From start of study treatment on Day 1 up to Day 28 and Follow up: From Day 29 to Day 41
|
12.5%
1/8 • On treatment: From start of study treatment on Day 1 up to Day 28 and Follow up: From Day 29 to Day 41
|
0.00%
0/7 • On treatment: From start of study treatment on Day 1 up to Day 28 and Follow up: From Day 29 to Day 41
|
0.00%
0/8 • On treatment: From start of study treatment on Day 1 up to Day 28 and Follow up: From Day 29 to Day 41
|
|
General disorders
Fatigue
|
14.3%
1/7 • On treatment: From start of study treatment on Day 1 up to Day 28 and Follow up: From Day 29 to Day 41
|
0.00%
0/8 • On treatment: From start of study treatment on Day 1 up to Day 28 and Follow up: From Day 29 to Day 41
|
0.00%
0/7 • On treatment: From start of study treatment on Day 1 up to Day 28 and Follow up: From Day 29 to Day 41
|
0.00%
0/8 • On treatment: From start of study treatment on Day 1 up to Day 28 and Follow up: From Day 29 to Day 41
|
|
Nervous system disorders
Headache
|
14.3%
1/7 • On treatment: From start of study treatment on Day 1 up to Day 28 and Follow up: From Day 29 to Day 41
|
12.5%
1/8 • On treatment: From start of study treatment on Day 1 up to Day 28 and Follow up: From Day 29 to Day 41
|
0.00%
0/7 • On treatment: From start of study treatment on Day 1 up to Day 28 and Follow up: From Day 29 to Day 41
|
0.00%
0/8 • On treatment: From start of study treatment on Day 1 up to Day 28 and Follow up: From Day 29 to Day 41
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.3%
1/7 • On treatment: From start of study treatment on Day 1 up to Day 28 and Follow up: From Day 29 to Day 41
|
12.5%
1/8 • On treatment: From start of study treatment on Day 1 up to Day 28 and Follow up: From Day 29 to Day 41
|
0.00%
0/7 • On treatment: From start of study treatment on Day 1 up to Day 28 and Follow up: From Day 29 to Day 41
|
0.00%
0/8 • On treatment: From start of study treatment on Day 1 up to Day 28 and Follow up: From Day 29 to Day 41
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
14.3%
1/7 • On treatment: From start of study treatment on Day 1 up to Day 28 and Follow up: From Day 29 to Day 41
|
0.00%
0/8 • On treatment: From start of study treatment on Day 1 up to Day 28 and Follow up: From Day 29 to Day 41
|
0.00%
0/7 • On treatment: From start of study treatment on Day 1 up to Day 28 and Follow up: From Day 29 to Day 41
|
0.00%
0/8 • On treatment: From start of study treatment on Day 1 up to Day 28 and Follow up: From Day 29 to Day 41
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus discomfort
|
14.3%
1/7 • On treatment: From start of study treatment on Day 1 up to Day 28 and Follow up: From Day 29 to Day 41
|
0.00%
0/8 • On treatment: From start of study treatment on Day 1 up to Day 28 and Follow up: From Day 29 to Day 41
|
0.00%
0/7 • On treatment: From start of study treatment on Day 1 up to Day 28 and Follow up: From Day 29 to Day 41
|
0.00%
0/8 • On treatment: From start of study treatment on Day 1 up to Day 28 and Follow up: From Day 29 to Day 41
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
14.3%
1/7 • On treatment: From start of study treatment on Day 1 up to Day 28 and Follow up: From Day 29 to Day 41
|
0.00%
0/8 • On treatment: From start of study treatment on Day 1 up to Day 28 and Follow up: From Day 29 to Day 41
|
0.00%
0/7 • On treatment: From start of study treatment on Day 1 up to Day 28 and Follow up: From Day 29 to Day 41
|
0.00%
0/8 • On treatment: From start of study treatment on Day 1 up to Day 28 and Follow up: From Day 29 to Day 41
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
14.3%
1/7 • On treatment: From start of study treatment on Day 1 up to Day 28 and Follow up: From Day 29 to Day 41
|
0.00%
0/8 • On treatment: From start of study treatment on Day 1 up to Day 28 and Follow up: From Day 29 to Day 41
|
0.00%
0/7 • On treatment: From start of study treatment on Day 1 up to Day 28 and Follow up: From Day 29 to Day 41
|
0.00%
0/8 • On treatment: From start of study treatment on Day 1 up to Day 28 and Follow up: From Day 29 to Day 41
|
|
Infections and infestations
COVID-19
|
0.00%
0/7 • On treatment: From start of study treatment on Day 1 up to Day 28 and Follow up: From Day 29 to Day 41
|
12.5%
1/8 • On treatment: From start of study treatment on Day 1 up to Day 28 and Follow up: From Day 29 to Day 41
|
0.00%
0/7 • On treatment: From start of study treatment on Day 1 up to Day 28 and Follow up: From Day 29 to Day 41
|
0.00%
0/8 • On treatment: From start of study treatment on Day 1 up to Day 28 and Follow up: From Day 29 to Day 41
|
|
Nervous system disorders
Dizziness
|
0.00%
0/7 • On treatment: From start of study treatment on Day 1 up to Day 28 and Follow up: From Day 29 to Day 41
|
0.00%
0/8 • On treatment: From start of study treatment on Day 1 up to Day 28 and Follow up: From Day 29 to Day 41
|
0.00%
0/7 • On treatment: From start of study treatment on Day 1 up to Day 28 and Follow up: From Day 29 to Day 41
|
12.5%
1/8 • On treatment: From start of study treatment on Day 1 up to Day 28 and Follow up: From Day 29 to Day 41
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER