Efficacy, Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of Oral Administration of AIM-102 in Patients With Mild to Moderate Allergic Asthma

Summary

Participation Requirements

Description

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 sh...

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 study is divided into 2 parts. Part 1: Screening Patients who meet all entry criteria will be screened with a history, physical examination, spirometry, and routine laboratory tests. If they continue to meet entry criteria, their atopic status will be documented by skin testing against common airborne allergens (including cat, dust mite, grass, pollen). Twenty-four (24) hr later, an allergen challenge will be performed to confirm the presence of an Early Asthmatic Response (EAR) and Late Asthmatic Response (LAR). Methacholine PC20 and sputum differentials will be performed before and after allergen challenges. Only patients with a documented early and late asthmatic response to inhaled incremental allergen challenge will be eligible for entry into Part 2 of the study. Part 2: Dosing and Follow-up Patients will be assigned to receive drug and placebo in a random order, with at least a two week washout between treatment periods. Spirometry, vital signs, and asthma symptomatology, methacholine challenge, sputum differentials will be evaluated before the first dose and again 24 hr before allergen challenge. Allergen challenge will be performed in the morning of Day 3 of dosing, post-dose, with spirometry measured until seven hr post-challenge. Sputum will also be induced at seven hr following the allergen challenge. Methacholine challenge and sputum induction will be performed 24 hr after allergen challenges. Any adverse events (AEs) and asthma symptoms will be evaluated at each clinic visit. A physical examination, vital signs, ECG, spirometry and laboratory tests will be repeated at the termination visit.

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