Overview

A Study to Evaluate the Effectiveness of JNJ 40929837 for the Treatment of Asthma Using a Bronchial Allergen Challenge Model

Status:
Completed

Trial end date:
2011-06-01

Target enrollment:
0

Participant gender:
All

Summary

The purpose of this study is to evaluate the allergen-induced late asthmatic response (LAR), as measured by maximal percent fall in forced expiratory volume in 1 second, in participants with stable mild atopic asthma after treatment with JNJ 40929837 as compared to placebo.

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Treatments:

Montelukast

Criteria

Inclusion Criteria: - Generally healthy - Have mild atopic asthma requiring no other
treatment besides occasional short-acting beta-2-agonists - Have allergen-induced early
asthmatic response of at least a 20 percent reduction in forced expiratory volume in 1
second (FEV1) and late asthmatic response of at least a 15 percent reduction in FEV1 during
bronchial allergen challenge performed at screening - Females who are post menopausal,
surgically sterilized, or practicing a highly effective method of birth control - Have an
FEV1 at screening visit at least 75 percent of the predicted value - Have a history of
asthma symptoms during exposure to indoor or outdoor allergens and a positive prick skin
test done at the study site to dust mite, mixed grass pollen, or cat dander Exclusion
Criteria: - Worsening of asthma or a respiratory tract infection within 6 weeks - HIV or
Hepatitis B or C positive - Receipt of an investigational drug or use of an investigational
medical device within the last month - Use of tobacco products of any kind currently or
within 6 months - Have clinically significant abnormal physical examination, vital signs,
or 12 lead electrocardiogram at screening as deemed appropriate by the investigator