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

• Sponsor: Teva Branded Pharmaceutical Products R&D, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00232999
• Collaborator: AllerGen NCE Inc. (Industry)
• Enrollment: 15
• Locations: 3
• Duration (Months): 3
• Patients Per Site: 5
• Patients Per Site Per Month: 1.7

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Asthma	Drug: Nebulized IVX-0142	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 15 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Study Start Date: Oct 1, 2005
• Actual Primary Completion Date: Dec 1, 2005
• Actual Study Completion Date: Jan 1, 2006

Outcome Measures

Primary Outcome Measures

1. 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

1. Methacholine PC20 pre- and post-allergen challenge []

2. Anti-inflammatory activity in airways []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

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

Sponsors and Collaborators

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

Investigators

• Principal Investigator: Paul M O'Byrne, MD, McMaster University and AllerGen NCE

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Teva Branded Pharmaceutical Products R&D, Inc.
• ClinicalTrials.gov Identifier: NCT00232999
• Other Study ID Numbers: IXR-201-04-142
• First Posted: Oct 5, 2005
• Last Update Posted: Nov 12, 2021
• Last Verified: Nov 1, 2021

• Keywords provided by Teva Branded Pharmaceutical Products R&D, Inc.: Allergic asthma; Allergen challenge; Bronchial hyperresponsiveness
• Additional relevant MeSH terms: Asthma

Study Results

No Results Posted as of Nov 12, 2021