Study Evaluating the Effects of IMA-638 on Allergen-Induced Airway Responses in Subjects With Mild Atopic Asthma

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00410280
First received: December 8, 2006
Last updated: June 26, 2008
Last verified: June 2008
  Purpose

Primary purpose of the protocol is to determine if IMA-638 prevents a mild asthma attack by a subject with mild asthma inhaling an allergen.


Condition Intervention Phase
Asthma
Biological: IMA-638 is a biologic
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Study Evaluating the Effects of IMA-638 on Allergen-Induced Airway Responses and Airway Inflammation in Subjects With Mild Atopic Asthma

Resource links provided by NLM:


Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Primary Outcome Measures:
  • Maximum change of forced expiratory volume in one second (FEV1) from baseline between IMA-638 and placebo [ Time Frame: 36 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: February 2007
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1 Biological: IMA-638 is a biologic

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • generally healthy, men and women with mild allergic asthma, aged 18 to 60 years
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00410280

Locations
Canada, British Columbia
Vancouver, British Columbia, Canada, V5Z 1M9
Canada, Ontario
Hamilton, Ontario, Canada, L8N 3Z5
Canada, Quebec
Sainte-Foy, Quebec, Canada, G1V 4G5
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
  More Information

No publications provided by Wyeth is now a wholly owned subsidiary of Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
ClinicalTrials.gov Identifier: NCT00410280     History of Changes
Other Study ID Numbers: 3174K1-200
Study First Received: December 8, 2006
Last Updated: June 26, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on April 17, 2014