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
1 other identifier
interventional
24
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 asthma
Started Sep 2008
Typical duration for phase_1 asthma
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 25, 2008
CompletedFirst Posted
Study publicly available on registry
July 30, 2008
CompletedStudy Start
First participant enrolled
September 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2009
CompletedJune 2, 2009
June 1, 2009
9 months
July 25, 2008
June 1, 2009
Conditions
Outcome Measures
Primary Outcomes (1)
Comparison of the maximum change in FEV1 from baseline for the LAR between IMA-026 and placebo
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
11 weeks
Study Arms (2)
A
EXPERIMENTALB
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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. doi: 10.1164/rccm.201008-1210OC. Epub 2010 Nov 5.
PMID: 21057005DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Monitor
Wyeth is now a wholly owned subsidiary of Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
July 25, 2008
First Posted
July 30, 2008
Study Start
September 1, 2008
Primary Completion
June 1, 2009
Study Completion
June 1, 2009
Last Updated
June 2, 2009
Record last verified: 2009-06