Back to resultsA Study to Evaluate the Effectiveness of JNJ 40929837 for the Treatment of Asthma Using a Bronchial Allergen Challenge Model
Primary Purpose
Asthma
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
JNJ 40929837
Placebo
Montelukast
Sponsored by
About this trial
This is an interventional treatment trial for Asthma focused on measuring Asthma, Mild asthma, Singulair, JNJ 40929837, Montelukast
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Placebo Comparator
Other
Arm Label
Treatment A: JNJ 40929837
Treatment B: Placebo
Treatment C: Montelukast
Arm Description
Outcomes
Primary Outcome Measures
Change in forced expiratory volume in 1 second (FEV1) during the late response to allergen
Secondary Outcome Measures
Change in FEV1 during the early response to allergen
Area under the FEV1/time curve during the early response to allergen
Area under the FEV1/time curve during the late response to allergen
Plasma concentration of JNJ 40929837
Sputum leukotriene B4 levels
This biomarker will be measured as a pharmacodynamic evaluation.
Plasma leukotriene B4 levels
This biomarker will be measured as a pharmacodynamic evaluation.
Full Information
NCT ID
NCT01241422
First Posted
October 25, 2010
Last Updated
December 18, 2015
Sponsor
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
1. Study Identification
Unique Protocol Identification Number
NCT01241422
Brief Title
A Study to Evaluate the Effectiveness of JNJ 40929837 for the Treatment of Asthma Using a Bronchial Allergen Challenge Model
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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 treatments a participant is receiving, but can access the information in case of an emergency), and crossover (method used to switch participants from one treatment arm to another in a clinical study) study. Approximately 18 participants will participate in the study. The study will consist of screening phase (30 days before the administration of study drug), treatment phase, and follow-up phase (2 weeks after the end of the last treatment period). Participants will be randomly assigned to receive JNJ 40929837, placebo, and montelukast. Each participant will receive all the 3 treatments (7 days per treatment) and each treatment will be separated by 14 days of wash-out period (no treatment). Safety evaluations will include assessments of adverse events, clinical laboratory tests, electrocardiogram, vital signs, and physical examination, which will be evaluated throughout the study. The maximum study duration for a participant will be approximately 51 days.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Asthma, Mild asthma, Singulair, JNJ 40929837, Montelukast
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment A: JNJ 40929837
Arm Type
Experimental
Arm Title
Treatment B: Placebo
Arm Type
Placebo Comparator
Arm Title
Treatment C: Montelukast
Arm Type
Other
Intervention Type
Drug
Intervention Name(s)
JNJ 40929837
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Montelukast
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in forced expiratory volume in 1 second (FEV1) during the late response to allergen
Time Frame
3 to 10 hours after allergen exposure on Day 6 of each treatment period
Secondary Outcome Measure Information:
Title
Change in FEV1 during the early response to allergen
Time Frame
0-2 hours after allergen exposure on Day 6 of each treatment period
Title
Area under the FEV1/time curve during the early response to allergen
Time Frame
Between 0 and 2 hours post allergen challenge on Day 6
Title
Area under the FEV1/time curve during the late response to allergen
Time Frame
Between 3 and 10 hours post allergen challenge on Day 6
Title
Plasma concentration of JNJ 40929837
Time Frame
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
Title
Sputum leukotriene B4 levels
Description
This biomarker will be measured as a pharmacodynamic evaluation.
Time Frame
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
Title
Plasma leukotriene B4 levels
Description
This biomarker will be measured as a pharmacodynamic evaluation.
Time Frame
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johnson & Johnson Pharmaceutical Research & Development, L.L C. Clinical Trial
Organizational Affiliation
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Official's Role
Study Director
Facility Information:
City
Berlin
Country
Germany
City
Harrow
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
25018015
Citation
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.
Results Reference
derived
Links:
URL
http://dx.doi.org/10.1016/j.pupt.2014.06.003
Description
Effects of JNJ-40929837, a leukotriene A4 hydrolase inhibitor, in a bronchial allergen challenge model of asthma W. 16 Barchuk et al. / Pulmonary Pharmacology & Therapeutics 29 (2014) 15e23
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A Study to Evaluate the Effectiveness of JNJ 40929837 for the Treatment of Asthma Using a Bronchial Allergen Challenge Model
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