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

This study has been completed.

First Received: December 8, 2006 Last Updated: June 26, 2008 History of Changes

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00410280

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 II

MedlinePlus related topics: Asthma

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

Further study details as provided by Wyeth:

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

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

Investigators

Study Director:

Medical Monitor

Wyeth

More Information

No publications provided

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

Study placed in the following topic categories:

Hypersensitivity
Lung Diseases, Obstructive
Respiratory Tract Diseases
Bronchial Diseases
Lung Diseases

Hypersensitivity, Immediate
Asthma
Respiratory Hypersensitivity
Inflammation

Additional relevant MeSH terms:

Hypersensitivity
Lung Diseases, Obstructive
Immune System Diseases
Respiratory Tract Diseases
Bronchial Diseases

Lung Diseases
Hypersensitivity, Immediate
Asthma
Respiratory Hypersensitivity

ClinicalTrials.gov processed this record on May 06, 2009