Back to resultsEfficacy/Safety Study of Nebulized IVX-0142, a Novel Antiallergic Drug, in Mild Allergic Asthma
Primary Purpose
Asthma
Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Nebulized IVX-0142
Sponsored by
About this trial
This is an interventional prevention trial for Asthma focused on measuring Allergic asthma, Allergen challenge, Bronchial hyperresponsiveness
Eligibility 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
Sites / Locations
- Department of Medicine, McMaster University
- Centre de cardiology et de pneumologie de l'Universite Laval
- University of Saskatchewan
Outcomes
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
Full Information
NCT ID
NCT00232999
First Posted
October 4, 2005
Last Updated
November 5, 2021
Sponsor
Teva Branded Pharmaceutical Products R&D, Inc.
Collaborators
AllerGen NCE Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00232999
Brief Title
Efficacy/Safety Study of Nebulized IVX-0142, a Novel Antiallergic Drug, in Mild Allergic Asthma
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
December 2005 (Actual)
Study Completion Date
January 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Teva Branded Pharmaceutical Products R&D, Inc.
Collaborators
AllerGen NCE Inc.
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Allergic asthma, Allergen challenge, Bronchial hyperresponsiveness
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Nebulized IVX-0142
Primary Outcome Measure Information:
Title
Serial lung function tests measured up to 7 hours post-allergen challenge to assess effects on early- and late-phase asthmatic reactions
Secondary Outcome Measure Information:
Title
Methacholine PC20 pre- and post-allergen challenge
Title
Anti-inflammatory activity in airways
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul M O'Byrne, MD
Organizational Affiliation
McMaster University and AllerGen NCE
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Medicine, McMaster University
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 3Z5
Country
Canada
Facility Name
Centre de cardiology et de pneumologie de l'Universite Laval
City
Sainte-Foy (Quebec City)
State/Province
Quebec
ZIP/Postal Code
G1V 4G5
Country
Canada
Facility Name
University of Saskatchewan
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7N 0W8
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
18699936
Citation
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.
Results Reference
result
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Efficacy/Safety Study of Nebulized IVX-0142, a Novel Antiallergic Drug, in Mild Allergic Asthma
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