Atopic Asthma
Conditions
Brief summary
A Double Masked, Placebo Controlled, Single Center, Randomized Clinical Trial to Assess the Safety and Efficacy of ADX-629 in Subjects with Mild Asthma Induced by the Bronchial Allergen Challenge (BAC)
Interventions
DRUGADX-629
ADX-629, 600 mg administered orally twice daily (PO bid) for a minimum of 1 week
DRUGPlacebo
Placebo, 600 mg administered orally twice daily (PO bid) for minimum 1 week
Sponsors
Aldeyra Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Male or non-pregnant female, between 18 to 65 years of age (inclusive) at Screening Visit. * Subjects must give their signed and dated written informed consent (in English) to participate prior to commencing any study-related activities and must be willing to comply with study procedures, study restrictions, study protocol, and return for the required assessments. * Female subjects of either non-childbearing potential or of child-bearing potential who commit to consistent and correct use of at least one highly effective or two effective forms of contraception starting at least 4 weeks prior to the Screening Visit and for at least 30 days post last dose of study drug. * Generally healthy subjects with mild controlled asthma for 2 years at Screening Visit according to the Global Initiative for Asthma criteria.
Exclusion criteria
* History and presence of clinically significant cardiovascular, renal, neurologic, hepatologic, endocrinologic, gastrointestinal, genitourinary, autoimmune, hematological, or metabolic disease other than asthma, which in the opinion of Investigator may either put the subject at risk or influence the results during the study. * Positive skin prick test to other perennial allergens (i.e., mold, dog with ≥ 3 mm wheal compared to negative control). Subjects with seasonal allergy symptoms that occur or are anticipated to occur during the study should result in subject exclusion or rescheduling until the subject is out of the allergy season. * Any relevant pulmonary disease within 1 year prior to dosing at the discretion of the investigator. * Recent hospitalization with asthma in the last 6 months or any other medical condition that the Investigator deems incompatible with participation in the trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Serious Adverse Events | The safety assessment period was Day 1 - Day 7 for each treatment intervention. | Safety was assessed through serious adverse event collection. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in the Asthma Control Questionnaire | 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. | 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. |
| Change From Baseline in Sputum Eosinophils Percentage of Total Leukocytes | 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. | 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. |
| Change From Baseline in Sputum Neutrophils Percentage of Total Leukocytes | 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. | 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. |
Countries
Canada
Participant flow
Pre-assignment details
Eight subjects were randomized in a crossover design trial.
Participants by arm
| Arm | Count |
|---|---|
| First ADX-629, Then Placebo ADX-629 300mg administered orally twice daily for one week, then a two-day washout, then placebo administered orally twice daily for one week. | 4 |
| 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. | 4 |
| Total | 8 |
Baseline characteristics
| Characteristic | First ADX-629, Then Placebo | First Placebo, Then ADX-629 | Total |
|---|---|---|---|
| Age, Continuous | 43.3 years STANDARD_DEVIATION 12 | 34.0 years STANDARD_DEVIATION 13.2 | 38.6 years STANDARD_DEVIATION 12.7 |
| Body Mass Index (BMI) | 28.0 kg/m2 STANDARD_DEVIATION 4.9 | 30.33 kg/m2 STANDARD_DEVIATION 3.2 | 29.16 kg/m2 STANDARD_DEVIATION 4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 4 Participants | 4 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 3 Participants | 3 Participants | 6 Participants |
| Sex: Female, Male Female | 4 Participants | 4 Participants | 8 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 8 | 0 / 8 |
| other Total, other adverse events | 1 / 8 | 1 / 8 |
| serious Total, serious adverse events | 0 / 8 | 0 / 8 |
Outcome results
Primary
Number of Subjects With Serious Adverse Events
Safety was assessed through serious adverse event collection.
Time frame: The safety assessment period was Day 1 - Day 7 for each treatment intervention.
Population: Safety population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ADX-629 | Number of Subjects With Serious Adverse Events | 0 participants |
| Placebo | Number of Subjects With Serious Adverse Events | 0 participants |
Secondary
Change From Baseline in Sputum Eosinophils Percentage of Total Leukocytes
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.
Time frame: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ADX-629 | Change From Baseline in Sputum Eosinophils Percentage of Total Leukocytes | 7 hours post-bronchial allergen challenge | 6.4 percentage | Standard Deviation 8.8 |
| ADX-629 | Change From Baseline in Sputum Eosinophils Percentage of Total Leukocytes | 24 hours post-bronchial allergen challenge | 0.1 percentage | Standard Deviation 1.8 |
| Placebo | Change From Baseline in Sputum Eosinophils Percentage of Total Leukocytes | 7 hours post-bronchial allergen challenge | 11.6 percentage | Standard Deviation 10.2 |
| Placebo | Change From Baseline in Sputum Eosinophils Percentage of Total Leukocytes | 24 hours post-bronchial allergen challenge | 16.2 percentage | Standard Deviation 20.4 |
Secondary
Change From Baseline in Sputum Neutrophils Percentage of Total Leukocytes
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.
Time frame: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ADX-629 | Change From Baseline in Sputum Neutrophils Percentage of Total Leukocytes | 7 hours post-bronchial allergen challenge | -8.5 percentage | Standard Deviation 16.1 |
| ADX-629 | Change From Baseline in Sputum Neutrophils Percentage of Total Leukocytes | 24 hours post-bronchial allergen challenge | 3.2 percentage | Standard Deviation 18.6 |
| Placebo | Change From Baseline in Sputum Neutrophils Percentage of Total Leukocytes | 7 hours post-bronchial allergen challenge | 4.3 percentage | Standard Deviation 14.5 |
| Placebo | Change From Baseline in Sputum Neutrophils Percentage of Total Leukocytes | 24 hours post-bronchial allergen challenge | 7.8 percentage | Standard Deviation 40.2 |
Secondary
Change From Baseline in the Asthma Control Questionnaire
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.
Time frame: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ADX-629 | Change From Baseline in the Asthma Control Questionnaire | -0.20 score on a scale | Standard Deviation 0.41 |
| Placebo | Change From Baseline in the Asthma Control Questionnaire | -0.05 score on a scale | Standard Deviation 0.52 |