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

Asthma Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00232999
• Other study ID #: IXR-201-04-142
• Status: Completed
• Phase: Phase 2
• Start date: October 2005
• Est. completion date: January 2006

Study information

• Verified date: November 2021
• Source: Teva Branded Pharmaceutical Products R&D, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: January 2006
• Est. primary completion date: December 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Nebulized IVX-0142

Locations

Country	Name	City	State
Canada	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

Sponsors (2)

Lead Sponsor	Collaborator
Teva Branded Pharmaceutical Products R&D, Inc.	AllerGen NCE Inc.

Country where clinical trial is conducted

Canada, 

References & 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. 200 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serial lung function tests measured up to 7 hours post-allergen challenge to assess effects on early- and late-phase asthmatic reactions
Secondary	Methacholine PC20 pre- and post-allergen challenge
Secondary	Anti-inflammatory activity in airways