Trial Outcomes & Findings for A Double Masked, Placebo Controlled, Single Center, Randomized Clinical Trial to Assess the Safety and Efficacy of Subjects With Mild Asthma Induced by the Bronchial Allergen Challenge (BAC) (NCT NCT04728711)
NCT ID: NCT04728711
Last Updated: 2025-02-17
Results Overview
Safety was assessed through serious adverse event collection.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
8 participants
Primary outcome timeframe
The safety assessment period was Day 1 - Day 7 for each treatment intervention.
Results posted on
2025-02-17
Participant Flow
Eight subjects were randomized in a crossover design trial.
Participant milestones
| Measure |
First ADX-629, Then Placebo
ADX-629 300mg (milligrams) administered orally twice daily for one week, then a two-day washout, then placebo administered orally twice daily for one week.
|
First Placebo, Then ADX-629
Placebo administered orally twice daily for one week, then a two-day washout, then ADX-629 300mg administered orally twice daily for one week.
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
4
|
|
Overall Study
COMPLETED
|
4
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Double Masked, Placebo Controlled, Single Center, Randomized Clinical Trial to Assess the Safety and Efficacy of Subjects With Mild Asthma Induced by the Bronchial Allergen Challenge (BAC)
Baseline characteristics by cohort
| Measure |
First ADX-629, Then Placebo
n=4 Participants
ADX-629 300mg administered orally twice daily for one week, then a two-day washout, then placebo administered orally twice daily for one week.
|
First Placebo, Then ADX-629
n=4 Participants
Placebo administered orally twice daily for one week, then a two-day washout, then ADX-629 300mg administered orally twice daily for one week.
|
Total
n=8 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
43.3 years
STANDARD_DEVIATION 12.0 • n=5 Participants
|
34.0 years
STANDARD_DEVIATION 13.2 • n=7 Participants
|
38.6 years
STANDARD_DEVIATION 12.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
|
Body Mass Index (BMI)
|
28.0 kg/m2
STANDARD_DEVIATION 4.9 • n=5 Participants
|
30.33 kg/m2
STANDARD_DEVIATION 3.2 • n=7 Participants
|
29.16 kg/m2
STANDARD_DEVIATION 4.0 • n=5 Participants
|
PRIMARY outcome
Timeframe: The safety assessment period was Day 1 - Day 7 for each treatment intervention.Population: Safety population
Safety was assessed through serious adverse event collection.
Outcome measures
| Measure |
ADX-629
n=8 Participants
ADX-629 300mg administered orally twice daily for 1 week
|
Placebo
n=8 Participants
Placebo administered orally twice daily for 1 week
|
|---|---|---|
|
Number of Subjects With Serious Adverse Events
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: The efficacy assessment period was Day 1 through Day 7 for each treatment period. Baseline is defined as the last non-missing assessment prior to randomization.Population: Intent-to-treat population
Change from baseline in the asthma control questionnaire, which is seven questions on a seven-point scale (0 = totally controlled, 6 = extremely poorly controlled). The first six questions are answered by the subject. The seventh question, concerning forced expiratory volume in 1 second (FEV1) percentage predicted (0 = \>95% predicted, 6 = \<50% predicted), is completed by clinic staff. The asthma control questionnaire is calculated as the mean of the response to all seven questions, with a higher score being more severe.
Outcome measures
| Measure |
ADX-629
n=8 Participants
ADX-629 300mg administered orally twice daily for 1 week
|
Placebo
n=8 Participants
Placebo administered orally twice daily for 1 week
|
|---|---|---|
|
Change From Baseline in the Asthma Control Questionnaire
|
-0.20 score on a scale
Standard Deviation 0.41
|
-0.05 score on a scale
Standard Deviation 0.52
|
SECONDARY outcome
Timeframe: The efficacy assessment period was Day 1 through 7 for each treatment period. Baseline is defined as the last non-missing assessment prior to randomization.Population: Intent-to-treat population
Change from baseline in sputum eosinophils percentage of total leukocytes at seven hours post bronchial allergen challenge and 24 hours post bronchial allergen challenge. A reduction in sputum eosinophils percentage demonstrates improvement.
Outcome measures
| Measure |
ADX-629
n=8 Participants
ADX-629 300mg administered orally twice daily for 1 week
|
Placebo
n=8 Participants
Placebo administered orally twice daily for 1 week
|
|---|---|---|
|
Change From Baseline in Sputum Eosinophils Percentage of Total Leukocytes
7 hours post-bronchial allergen challenge
|
6.4 percentage
Standard Deviation 8.8
|
11.6 percentage
Standard Deviation 10.2
|
|
Change From Baseline in Sputum Eosinophils Percentage of Total Leukocytes
24 hours post-bronchial allergen challenge
|
0.1 percentage
Standard Deviation 1.8
|
16.2 percentage
Standard Deviation 20.4
|
SECONDARY outcome
Timeframe: The efficacy assessment period was Day 1 through Day 7 for each treatment period. Baseline is defined as the last non-missing assessment prior to randomization.Population: Intent-to-treat population
Change from baseline in sputum neutrophils percentage of total leukocytes at 7 hours post bronchial allergen challenge and 24 hours post bronchial allergen challenge. A reduction in sputum neutrophils percentage demonstrates improvement.
Outcome measures
| Measure |
ADX-629
n=8 Participants
ADX-629 300mg administered orally twice daily for 1 week
|
Placebo
n=8 Participants
Placebo administered orally twice daily for 1 week
|
|---|---|---|
|
Change From Baseline in Sputum Neutrophils Percentage of Total Leukocytes
7 hours post-bronchial allergen challenge
|
-8.5 percentage
Standard Deviation 16.1
|
4.3 percentage
Standard Deviation 14.5
|
|
Change From Baseline in Sputum Neutrophils Percentage of Total Leukocytes
24 hours post-bronchial allergen challenge
|
3.2 percentage
Standard Deviation 18.6
|
7.8 percentage
Standard Deviation 40.2
|
Adverse Events
ADX-629
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
ADX-629
n=8 participants at risk
ADX-629 300 milligrams administered orally twice daily for 1 week
|
Placebo
n=8 participants at risk
Placebo administered orally twice daily for 1 week
|
|---|---|---|
|
Metabolism and nutrition disorders
Decreased appetite
|
12.5%
1/8 • Number of events 1 • One week for each intervention
|
0.00%
0/8 • One week for each intervention
|
|
Psychiatric disorders
Insomnia
|
12.5%
1/8 • Number of events 1 • One week for each intervention
|
0.00%
0/8 • One week for each intervention
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.5%
1/8 • Number of events 1 • One week for each intervention
|
0.00%
0/8 • One week for each intervention
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
12.5%
1/8 • Number of events 1 • One week for each intervention
|
0.00%
0/8 • One week for each intervention
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/8 • One week for each intervention
|
12.5%
1/8 • Number of events 1 • One week for each intervention
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/8 • One week for each intervention
|
12.5%
1/8 • Number of events 1 • One week for each intervention
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place