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

This study has been completed.

Sponsors and Collaborators:	IVAX Research LLC AllerGen
Information provided by:	IVAX Research LLC
ClinicalTrials.gov Identifier:	NCT00232999

Purpose

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.

Condition	Intervention	Phase
Asthma	Drug: Nebulized IVX-0142	Phase II

MedlinePlus related topics: Asthma

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study

Further study details as provided by IVAX Research LLC:

Primary Outcome Measures:

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:

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

Estimated Enrollment:	15
Study Start Date:	October 2005

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00232999

Locations

Canada, Ontario
Department of Medicine, McMaster University
Hamilton, Ontario, Canada, L8N 3Z5
Canada, Quebec
Centre de cardiology et de pneumologie de l'Universite Laval
Sainte-Foy (Quebec City), Quebec, Canada, G1V 4G5
Canada, Saskatchewan
University of Saskatchewan
Saskatoon, Saskatchewan, Canada, S7N 0W8

Sponsors and Collaborators

IVAX Research LLC

AllerGen

Investigators

Principal Investigator:

Paul M O'Byrne, MD

McMaster University and AllerGen NCE

More Information

Publications of Results:

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.

Study ID Numbers:	IXR-201-04-142
Study First Received:	October 4, 2005
Last Updated:	September 30, 2008
ClinicalTrials.gov Identifier:	NCT00232999
Health Authority:	Canada: Health Canada

Keywords provided by IVAX Research LLC:

Allergic asthma
Allergen challenge
Bronchial hyperresponsiveness

Study placed in the following topic categories:

Hypersensitivity
Lung Diseases, Obstructive
Respiratory Tract Diseases
Lung Diseases

Hypersensitivity, Immediate
Asthma
Bronchial Hyperreactivity
Respiratory Hypersensitivity

Additional relevant MeSH terms:

Immune System Diseases
Bronchial Diseases

ClinicalTrials.gov processed this record on January 16, 2009