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

NCT00232999 | Completed Phase 2

• 1 other identifier: IXR-201-04-142
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 3

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.

Conditions

Asthma

Keywords

Allergic asthma; Allergen challenge; Bronchial hyperresponsiveness

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (2)

• Methacholine PC20 pre- and post-allergen challenge

• Anti-inflammatory activity in airways

Interventions

Nebulized IVX-0142 DRUG

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Teva Branded Pharmaceutical Products R&D, Inc.: lead
• AllerGen NCE Inc.: collaborator

Study Sites (3)

Department of Medicine, McMaster University

Hamilton, Ontario, L8N 3Z5, Canada

Location

Centre de cardiology et de pneumologie de l'Universite Laval

Sainte-Foy (Quebec City), Quebec, G1V 4G5, Canada

Location

University of Saskatchewan

Saskatoon, Saskatchewan, S7N 0W8, Canada

Location

Related Publications (1)

• Duong M, Cockcroft D, Boulet LP, Ahmed T, Iverson H, Atkinson DC, Stahl EG, Watson R, Davis B, Milot J, Gauvreau GM, O'Byrne PM. The effect of IVX-0142, a heparin-derived hypersulfated disaccharide, on the allergic airway responses in asthma. Allergy. 2008 Sep;63(9):1195-201. doi: 10.1111/j.1398-9995.2008.01707.x.

  PMID: 18699936 RESULT

MeSH Terms

Conditions

Asthma; Bronchial Hyperreactivity

Condition Hierarchy (Ancestors)

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

Study Officials

• Paul M O'Byrne, MD

  McMaster University and AllerGen NCE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2005
• First Posted: October 5, 2005
• Study Start: October 1, 2005
• Primary Completion: December 1, 2005
• Study Completion: January 1, 2006
• Last Updated: November 12, 2021

Record last verified: 2021-11

Locations

CA (3)