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

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00725582
First received: July 25, 2008
Last updated: June 1, 2009
Last verified: June 2009

July 25, 2008
June 1, 2009
September 2008
June 2009   (final data collection date for primary outcome measure)
Comparison of the maximum change in FEV1 from baseline for the LAR between IMA-026 and placebo [ Time Frame: 11 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00725582 on ClinicalTrials.gov Archive Site
Treatment comparison of the hour 3 and hour 7 FEV1 AUC for the LAR; various comparisons of the methacholine PC20 [ Time Frame: 11 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Study Evaluating the Effect of IMA-026 on Allergen-Induced Late Asthma Response in Mild Asthma
The Effects of IMA-026 on Allergen-Induced Airway Responses and Airway Inflammation in Subjects With Mild Atopic 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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Asthma
  • Drug: IMA-026
  • Other: Placebo
  • Experimental: A
    Intervention: Drug: IMA-026
  • Placebo Comparator: B
    Intervention: Other: Placebo
Gauvreau GM, Boulet LP, Cockcroft DW, Fitzgerald JM, Carlsten C, Davis BE, Deschesnes F, Duong M, Durn BL, Howie KJ, Hui L, Kasaian MT, Killian KJ, Strinich TX, Watson RM, Y N, Zhou S, Raible D, O'Byrne PM. Effects of interleukin-13 blockade on allergen-induced airway responses in mild atopic asthma. Am J Respir Crit Care Med. 2011 Apr 15;183(8):1007-14. Epub 2010 Nov 5.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
June 2009
June 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  1. Upper respiratory infection or asthma exacerbation with 4 weeks of screening
  2. Serious infection requiring parenteral antibiotics or hospitalization with 4 weeks of test article administration
  3. Positive radiographic findings indicative of respiratory disease other than asthma
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00725582
3192K1-1002
No
Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP