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 (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00410280
First received: December 8, 2006
Last updated: April 11, 2014
Last verified: April 2014
  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 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 ]

Enrollment: 30
Study Start Date: March 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Pfizer
Investigators
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
  More Information

No publications provided by Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00410280     History of Changes
Other Study ID Numbers: 3174K1-200, B2421001
Study First Received: December 8, 2006
Last Updated: April 11, 2014
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 August 21, 2014