Skip to main content
OpenTrials
Completed

NCT Number: NCT00725582

Study Evaluating the Effect of IMA-026 on Allergen-Induced Late Asthma Response in Mild Asthma

The purpose of this study is to evaluate the effect of IMA-026, an antibody to IL-13, on airway hyperresponsiveness and airway inflammation in mild asthmatics. IMA-026 will be given as 2 injections under the skin 1 week apart at 2 mg/kg each dose. The study will include a screening period and a treatment period which includes doses on day 1 and day 8.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Asthma Bronchial Diseases 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 1

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Healthy men and women 18 to 60 yrs with mild allergic asthma
  • only asthma med is short-acting bronchodilator used not more than twice weekly
  • FEV1 greater than 70% predicted and a demonstrated baseline late response to allergen induction

Exclusion criteria

  • Upper respiratory infection or asthma exacerbation with 4 weeks of screening
  • Serious infection requiring parenteral antibiotics or hospitalization with 4 weeks of test article administration
  • Positive radiographic findings indicative of respiratory disease other than asthma

Treatment and study plan

IMA-026

Drug

Placebo

Other

Primary outcomes

  1. Comparison of the maximum change in FEV1 from baseline for the LAR between IMA-026 and placebo

    Time frame: 11 weeks

Secondary outcomes

  1. Treatment comparison of the hour 3 and hour 7 FEV1 AUC for the LAR; various comparisons of the methacholine PC20

    Time frame: 11 weeks

Sponsors and collaborators

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Industry

Registry information

Official study title

The Effects of IMA-026 on Allergen-Induced Airway Responses and Airway Inflammation in Subjects With Mild Atopic Asthma

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jul 30, 2008
Registry last updated
Jun 2, 2009

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.