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

This study has been completed.
Sponsor:
Collaborator:
AllerGen NCE Inc.
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Teva Branded Pharmaceutical Products, R&D Inc. )
ClinicalTrials.gov Identifier:
NCT00232999
First received: October 4, 2005
Last updated: July 3, 2012
Last verified: September 2008
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceutical Industries:

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

Enrollment: 15
Study Start Date: October 2005
Study Completion Date: January 2006
Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Teva Branded Pharmaceutical Products, R&D Inc.
AllerGen NCE Inc.
Investigators
Principal Investigator: Paul M O'Byrne, MD McMaster University and AllerGen NCE
  More Information

Publications:
Responsible Party: Teva Pharmaceutical Industries ( Teva Branded Pharmaceutical Products, R&D Inc. )
ClinicalTrials.gov Identifier: NCT00232999     History of Changes
Other Study ID Numbers: IXR-201-04-142
Study First Received: October 4, 2005
Last Updated: July 3, 2012
Health Authority: Canada: Health Canada

Keywords provided by Teva Pharmaceutical Industries:
Allergic asthma
Allergen challenge
Bronchial hyperresponsiveness

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on September 18, 2014