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OpenTrials
Completed

NCT Number: NCT00232999

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

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.

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Key information

Conditions

Asthma Bronchial Diseases Bronchial Hyperreactivity Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Department of Medicine, McMaster University, Hamilton, Ontario, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nebulized IVX-0142

Drug

Primary outcomes

  1. Serial lung function tests measured up to 7 hours post-allergen challenge to assess effects on early- and late-phase asthmatic reactions

Secondary outcomes

  1. Methacholine PC20 pre- and post-allergen challenge

  2. Anti-inflammatory activity in airways

Sponsors and collaborators

Lead sponsor

Teva Branded Pharmaceutical Products R&D, Inc.

Industry

Collaborators

  • AllerGen NCE Inc.

Registry information

Important dates

Study start
2005
Primary completion
2005
Study completion
2006
First posted
Oct 5, 2005
Registry last updated
Nov 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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