Efficacy/Safety Study of Nebulized IVX-0142, a Novel Antiallergic Drug, in Mild Allergic Asthma

Phase 2

Completed

• Conditions: Asthma

• Registration Number: NCT00232999
• Lead Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.

Brief Summary

This study is designed to evaluate the effectiveness of nebulized IVX-0142, a novel anti-allergic drug, to inhibit allergen-induced airway narrowing in patients with allergic asthma and the related increased sensitivity of the airways to other substances, as well as to investigate a possible anti-inflammatory effect of the drug in the airways.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-10
• Study First Submitted: 2005-10-04
• Study First Submitted QC: 2005-10-04
• Study First Posted: 2005-10-05
• Primary Completion: 2005-12
• Study Completion: 2006-01
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-05
• Last Update Posted: 2021-11-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• Mild stable allergic asthma
• Positive skin-prick test to at least one common aeroallergen
• Positive methacholine challenge
• Positive allergen-induced early- and late-phase airway bronchoconstriction
• General good health

Exclusion Criteria

• Lung diseases other than mild allergic asthma
• History or symptoms of cardiovascular disease, significant neurologic disease, and/or clinically significant autoimmune disease
• Chronic use of asthma medications other than short or intermediate beta-agonists or ipratropium
• Use of tobacco products within one year starting study or smoking history >10 pack years
• If female, pregnant or lactating or have positive pregnancy test at screening

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Serial lung function tests measured up to 7 hours post-allergen challenge to assess effects on early- and late-phase asthmatic reactions

Secondary Outcome Measures

Name	Time	Method
Methacholine PC20 pre- and post-allergen challenge
Anti-inflammatory activity in airways

Trial Locations

Locations (3)

Department of Medicine, McMaster University; 🇨🇦 Hamilton, Ontario, Canada

Centre de cardiology et de pneumologie de l'Universite Laval; 🇨🇦 Sainte-Foy (Quebec City), Quebec, Canada

University of Saskatchewan; 🇨🇦 Saskatoon, Saskatchewan, Canada