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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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ClinicalTrials.gov Identifier: NCT01241422
Recruitment Status : Completed
First Posted : November 16, 2010
Last Update Posted : December 21, 2015
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Asthma Drug: JNJ 40929837 Drug: Placebo Drug: Montelukast Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : November 2010
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
Drug Information available for: Montelukast

Arms and Interventions
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Arm Intervention/treatment
Experimental: Treatment A: JNJ 40929837 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.
Placebo Comparator: Treatment B: Placebo 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.
Treatment C: Montelukast 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.


Outcome Measures
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Primary Outcome Measures :
  1. 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 Measures :
  1. Change in FEV1 during the early response to allergen [ Time Frame: 0-2 hours after allergen exposure on Day 6 of each treatment period ]
  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. 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 ]
    This biomarker will be measured as a pharmacodynamic evaluation.

  6. 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 ]
    This biomarker will be measured as a pharmacodynamic evaluation.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01241422


Locations
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Germany
Berlin, Germany
United Kingdom
Harrow, United Kingdom
Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Investigators
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Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier: NCT01241422    
Other Study ID Numbers: CR017533
40929837ASH2001 ( Other Identifier: Johnson & Johnson Pharmaceutical Research and Development, L.L.C. )
First Posted: November 16, 2010    Key Record Dates
Last Update Posted: December 21, 2015
Last Verified: December 2015
Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
Asthma
Mild asthma
Singulair
JNJ 40929837
Montelukast
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Montelukast
 Anti-Asthmatic Agents
Respiratory System Agents
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP1A2 Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action