A Study to Evaluate the Effectiveness of JNJ 40929837 for the Treatment of Asthma Using a Bronchial Allergen Challenge Model
A Randomized, Double-Blind, Placebo- and Active-Controlled Crossover Study to Evaluate the Efficacy of JNJ 40929837 for the Treatment of Asthma Using a Bronchial Allergen Challenge Model
2 other identifiers
interventional
22
2 countries
2
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 mild atopic asthma after treatment with JNJ 40929837 as compared to placebo.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 asthma
Started Nov 2010
Shorter than P25 for phase_2 asthma
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 25, 2010
CompletedStudy Start
First participant enrolled
November 1, 2010
CompletedFirst Posted
Study publicly available on registry
November 16, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedDecember 21, 2015
December 1, 2015
7 months
October 25, 2010
December 18, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in forced expiratory volume in 1 second (FEV1) during the late response to allergen
3 to 10 hours after allergen exposure on Day 6 of each treatment period
Secondary Outcomes (6)
Change in FEV1 during the early response to allergen
0-2 hours after allergen exposure on Day 6 of each treatment period
Area under the FEV1/time curve during the early response to allergen
Between 0 and 2 hours post allergen challenge on Day 6
Area under the FEV1/time curve during the late response to allergen
Between 3 and 10 hours post allergen challenge on Day 6
Plasma concentration of JNJ 40929837
Day 1 (predose and 1, 2, 3, and 4 hours), pre-bronchial allergen challenge (BAC) Day 5 (predose and 2 hours), BAC Day 6 (predose and post-BAC [2 and 7 hours]), post-BAC Day 7 (predose and 2 hours), and follow-up visit
Sputum leukotriene B4 levels
Day 1 (predose and 2 and 4 hours), pre-BAC Day 5 (predose), BAC Day 6 (predose, post-BAC [2 and 7 hours]), post-BAC Day 7 (predose), and follow-up visit
- +1 more secondary outcomes
Study Arms (3)
Treatment A: JNJ 40929837
EXPERIMENTALTreatment B: Placebo
PLACEBO COMPARATORTreatment C: Montelukast
OTHERInterventions
On Day 1: participants will receive 2 tablets of 50 mg JNJ 40929837 in the morning and 1 placebo capsule in the evening; from Days 2 to 6: they will receive 1 tablet of 50 mg JNJ 40929837 in the morning and 1 JNJ 40929837 50 mg tablet + 1 placebo capsule in the evening; and on Day 7: 1 tablet of 50 mg JNJ 40929837 in the morning.
On Day 1: participants will receive 2 placebo tablets in the morning and 1 placebo capsule in the evening; from Days 2 to 6: they will receive 1 placebo tablet in the morning and 1 placebo tablet + 1 placebo capsule in the evening; and on Day 7: 1 placebo tablet in the morning.
On Day 1: participants will receive 2 placebo tablets in the morning and 1 montelukast capsule in the evening; from Days 2 to 6: they will receive 1 placebo tablet in the morning and 1 montelukast capsule + 1 placebo tablet in the evening; and on Day 7: 1 placebo tablet in the morning.
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Unknown Facility
Berlin, Germany
Unknown Facility
Harrow, United Kingdom
Related Publications (1)
Barchuk W, Lambert J, Fuhr R, Jiang JZ, Bertelsen K, Fourie A, Liu X, Silkoff PE, Barnathan ES, Thurmond R. Effects of JNJ-40929837, a leukotriene A4 hydrolase inhibitor, in a bronchial allergen challenge model of asthma. Pulm Pharmacol Ther. 2014 Oct;29(1):15-23. doi: 10.1016/j.pupt.2014.06.003. Epub 2014 Jul 10.
PMID: 25018015DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Johnson & Johnson Pharmaceutical Research & Development, L.L C. Clinical Trial
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 25, 2010
First Posted
November 16, 2010
Study Start
November 1, 2010
Primary Completion
June 1, 2011
Study Completion
June 1, 2011
Last Updated
December 21, 2015
Record last verified: 2015-12