A Double-blind, Placebo-controlled, Cross-over Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of Oral Administration of AIM-102 in Patients With Mild to Moderate Allergic Asthma
Sponsor study identifier
interventional
11
1 country
2
Study Start
February 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
February 2013
Actual (reported)Study Completion
March 2013
Actual (reported)This is a Phase II, double-blind, placebo-controlled, cross-over trial to evaluate the efficacy of AIM-102 for the treatment of allergen-induced asthma. Individuals with stable, mild to moderate allergic asthma by American Thoracic Society (ATS) criteria (1), with a history of episodic wheeze and shortness of breath, will be eligible for enrollment. The patients will receive 4 consecutive days of dosing of AIM-102 or placebo (inactive product) with an allergen challenge on day 3 of dosing to see how the patient's lung function is changed by using AIM-102 or placebo.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2013
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 26, 2011
Actual (reported)December 30, 2011
Actual (reported)February 2012
Date type not reportedThis date has not been verified as actual or estimated.
February 2013
Actual (reported)March 2013
Actual (reported)Change from baseline of the allergen-induced late asthmatic response (LAR) between AIM-102 and placebo.
Spirometry and the presence and severity of asthma symptoms will be assessed immediately before and immediately after each dose. Baseline and allergen-induced methacholine PC20, allergen-induced bronchoconstriction and allergen-induced airway inflammation will be assessed. AUC and maximum decrease in FEV1 for the late response will be compared between treatments using a one-way analysis of variance for the effects of treatment.
Pre dose(s) and post dose(s) and 7 and 24 hours post allergen challenge
Early Asthmatic Response
Pre-dose(s) and post-dose(s) and 3 hours after allergen challenge
• Comparison of the allergen-induced changes in sputum eosinophils at 7 hr and 24 hr post allergen, between the AIM-102 and placebo
Pre-dose and post-dose(s) and 7 and 24 hours post allergen challenge
Comparison of allergen-induced inflammatory mediators at 7 hr and 24 hr post allergen, between AIM-102 and placebo.
Pre-dose and post-dose(s) and 7 and 24 hours post allergen challenge
Comparison of the allergen-induced airway hyperresponsiveness at 24 hours (hr) post allergen, between AIM-102 and placebo
Pre-dose and 24 hours post allergen challenge
To determine the pharmacokinetic (PK) profile of AIM-102 in normal healthy mild to moderate asthmatic patients upon repeat dosing of AIM-102
Pre-dose for dosing Days 1, 2, 3, 4, & an optional Day 5, additional samples on Day 3 post-dose & allergen challenge,pre-dose, 1.5, 3, 4.5, 6, & 7.5 hr post-dose
The active drug product is an oral solution of AIM-102 in phosphate buffered saline at a concentration of 35.0 mg/ml.
The matching placebo is an oral solution of phosphate buffered saline
AIM-102 is supplied as an oral solution. Dose is 15 mg of AIM-102 per kg of patient weight measured on Treatment Day 1 of each treatment phase The study drug will be administered for 4 consecutive days with at least a 2 week wash-out period prior to crossing over to the alternative treatment for 4 days.
The matching placebo is an oral solution of phosphate buffered saline
McMaster University
Hamilton, Ontario, L8N 3Z5, Canada
Institut de cardiologie et de pneumologie de l'Hôpital Laval
Laval, Quebec, G1V 4G5, Canada
Paul O'Byrne, MD
McMaster University
11 participants (actual enrollment reported by the registry).
First Submitted
December 26, 2011
First Posted
December 30, 2011
Study Start
February 2012
Date type not reportedThis date has not been verified as actual or estimated.
A Placebo and Active Controlled Study of ONO-6950 Following Allergen Challenge in Patients With Asthma
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Primary Completion
February 2013
Actual (reported)Study Completion
March 2013
Actual (reported)Last Updated
February 14, 2014
Record last verified: 2014-02
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Source: ClinicalTrials.gov.
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