MedDataX Logo

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

NCT ID: NCT00232999

Last Updated: 2021-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-31

Study Completion Date

2006-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Asthma

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Allergic asthma Allergen challenge Bronchial hyperresponsiveness

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Nebulized IVX-0142

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

AllerGen NCE Inc.

INDUSTRY

Sponsor Role collaborator

Teva Branded Pharmaceutical Products R&D, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Paul M O'Byrne, MD

Role: PRINCIPAL_INVESTIGATOR

McMaster University and AllerGen NCE

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Department of Medicine, McMaster University

Hamilton, Ontario, Canada

Site Status

Centre de cardiology et de pneumologie de l'Universite Laval

Sainte-Foy (Quebec City), Quebec, Canada

Site Status

University of Saskatchewan

Saskatoon, Saskatchewan, Canada

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Canada

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 18699936 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IXR-201-04-142

Identifier Type: -

Identifier Source: org_study_id