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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) | Clinical Trials | Clareo Health

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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)

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)

NCT04728711•Aldeyra Therapeutics, Inc.

View on ClinicalTrials.gov

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)

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

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.

Locations (1)

Cliantha Research

Mississauga, Ontario, Canada

Key Dates

Start Date

January 9, 2021

Primary Completion Date

January 18, 2022

Completion Date

January 18, 2022

Last Updated

February 17, 2025

Enrollment

ACTUAL participants

Conditions

Atopic Asthma

Interventions

ADX-629

DRUG

Placebo

DRUG

A Study To Evaluate The Efficacy, Safety, Pharmacokinetics, And Pharmacodynamic Effects Of GDC-6599 In Patients With Chronic Cough

NCT05660850

Chronic Refractory Cough (CRC) With Non-atopic AsthmaCRC With Atopic Asthma+3 more

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NOT_YET_RECRUITINGNA

Vibroacoustic Therapy With Oscillating Positive Expiratory Pressure in the Treatment of Nasal Congestion

NCT07114107

Atopic RhinitisAtopic Asthma

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 17, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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)

Inclusion Criteria

Exclusion Criteria

A Study To Evaluate The Efficacy, Safety, Pharmacokinetics, And Pharmacodynamic Effects Of GDC-6599 In Patients With Chronic Cough

Vibroacoustic Therapy With Oscillating Positive Expiratory Pressure in the Treatment of Nasal Congestion

Airway Response to Repeat Allergen Challenge and the Effect of Ibuprofen in Mild Atopic Asthma

Randomized Controlled Trial of Silymarin in Asthma

Differential Gene Expression in Lung and Peripheral Blood After Inhaled Allergen Challenge

A Study to Evaluate Safety, Tolerability and Pharmacokinetics of ADC3680B in Subjects With Partly Controlled Atopic Asthma