Study Evaluating the Effects of AIR645 on Allergen-Induced Airway Responses in Subjects With Mild Atopic Asthma

A Phase 2a, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Bronchial Allergen Challenge Study to Assess the Safety, Tolerability, and Efficacy of Inhaled AIR645 in Subjects With Mild Allergic Asthma

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00941577

Enrollment

Registered

2009-07-17

Start date

2009-10-31

Completion date

2010-06-30

Last updated

2010-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Keywords

Hypersensitivity, Lung Diseases, Obstructive, Immune System Diseases, Respiratory Tract Diseases, Bronchial Diseases, Lung Diseases, Hypersensitivity, Immediate, Asthma, Respiratory Hypersensitivity

Brief summary

To assess the efficacy of inhaled AIR645 in the suppression of the Asthmatic Responses in subjects with mild asthma inhaling an allergen.

Interventions

DRUGAIR645

AIR645 (blinded) by nebulization, range of doses, maximum of one dose per day, maximum of 6 doses in 22 days.

DRUGPhysiologic saline solution

Placebo (blinded) by nebulization, range of doses, maximum of one dose per day, maximum of 6 doses in 22 days.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* Men and women with well controlled mild allergic asthma, aged 18 to 65 years * Only asthma med is short-acting bronchodilator used not more than twice weekly * FEV1 greater than 70% predicted and a demonstrated baseline late response to allergen induction

Design outcomes

Primary

Measure	Time frame
Area under the curve (AUC) of the percentage decrease forced expiratory volume in one second (FEV1) from baseline between AIR645 and placebo	36 days

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026