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

This study has been completed.
AllerGen NCE Inc.
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Teva Branded Pharmaceutical Products, R&D Inc. ) Identifier:
First received: October 4, 2005
Last updated: July 3, 2012
Last verified: September 2008
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
Drug: Nebulized IVX-0142
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Participant, 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)

Ages Eligible for Study:   18 Years to 60 Years   (Adult)
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
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Please refer to this study by its identifier: NCT00232999

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.
Principal Investigator: Paul M O'Byrne, MD McMaster University and AllerGen NCE
  More Information

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

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

Additional relevant MeSH terms:
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases processed this record on April 28, 2017