Status:

COMPLETED

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

Lead Sponsor:

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

Conditions:

Asthma

Eligibility:

All Genders

18-55 years

Phase:

PHASE2

Brief 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 mi...

Detailed Description

This is a multicenter (study conducted at multiple sites), randomized (the study medication is assigned by chance), double-blind (neither the physician nor participant will know which of the treatment...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

November 1 2010

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

June 1 2011

Estimated Enrollment :

22 Patients enrolled

Trial Details

Trial ID

NCT01241422

Start Date

November 1 2010

End Date

June 1 2011

Last Update

December 21 2015

Active Locations (2)

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Page 1 of 1 (2 locations)

1

Berlin, Germany

2

Harrow, United Kingdom