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

NCT ID: NCT00941577

Last Updated: 2010-07-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2010-06-30

Brief Summary

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

Detailed Description

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Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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AIR645

AIR645 (an IL-4/IL-13 dual cytokine signaling inhibitor) solution (diluent: physiologic saline solution)

Group Type EXPERIMENTAL

AIR645

Intervention Type DRUG

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

Physiologic saline solution

Physiologic saline solution

Group Type PLACEBO_COMPARATOR

Physiologic saline solution

Intervention Type DRUG

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

Interventions

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AIR645

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

Intervention Type DRUG

Physiologic saline solution

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Altair Therapeutics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Altair Therapeutics Inc.

Principal Investigators

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Mike Hodges, MD

Role: STUDY_DIRECTOR

Altair Therapeutics, Inc.

Locations

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Hamilton, Ontario, Canada

Site Status

Laval, Quebec, Canada

Site Status

Saskatoon, Saskatchewan, Canada

Site Status

Countries

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Canada

Other Identifiers

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AIR645-CS2

Identifier Type: -

Identifier Source: org_study_id

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