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

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

Overview[ - collapse ][ - ]

Purpose	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.
Condition	Asthma
Intervention	Drug: JNJ 40929837 Drug: Placebo Drug: Montelukast
Phase	Phase 2
Sponsor	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Responsible Party	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier	NCT01241422
First Received	October 25, 2010
Last Updated	March 11, 2014
Last verified	March 2014

Tracking Information[ + expand ][ + ]

First Received Date	October 25, 2010
Last Updated Date	March 11, 2014
Start Date	November 2010
Estimated Primary Completion Date	June 2011
Current Primary Outcome Measures	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] [Designated as safety issue: No]
Current Secondary Outcome Measures	Change in FEV1 during the early response to allergen [Time Frame: 0-2 hours after allergen exposure on Day 6 of each treatment period] [Designated as safety issue: No] 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] [Designated as safety issue: No] 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] [Designated as safety issue: No] 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] [Designated as safety issue: No] Sputum leukotriene B4 levels [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] [Designated as safety issue: No]This biomarker will be measured as a pharmacodynamic evaluation. Plasma leukotriene B4 levels [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] [Designated as safety issue: No]This biomarker will be measured as a pharmacodynamic evaluation.

Descriptive Information[ + expand ][ + ]

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
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.
Study Type	Interventional
Study Phase	Phase 2
Study Design	Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Condition	Asthma
Intervention	Drug: JNJ 40929837 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. Drug: Placebo 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. Drug: Montelukast 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.
Study Arm (s)	Experimental: Treatment A: JNJ 40929837 Placebo Comparator: Treatment B: Placebo Other: Treatment C: Montelukast

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	22
Estimated Completion Date	June 2011
Estimated Primary Completion Date	June 2011
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
Gender	Both
Ages	18 Years
Accepts Healthy Volunteers	No
Contacts	Not Provided
Location Countries	Germany, United Kingdom

Administrative Information[ + expand ][ + ]

NCT Number	NCT01241422
Other Study ID Numbers	CR017533
Has Data Monitoring Committee	Yes
Information Provided By	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Study Sponsor	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborators	Not Provided
Investigators	Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Verification Date	March 2014

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