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

NCT ID: NCT01241422

Last Updated: 2015-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2011-06-30

Brief Summary

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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

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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.

Conditions

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Asthma

Keywords

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Asthma Mild asthma Singulair JNJ 40929837 Montelukast

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Treatment A: JNJ 40929837

Group Type EXPERIMENTAL

JNJ 40929837

Intervention Type DRUG

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.

Treatment B: Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Group Type OTHER

Montelukast

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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Inclusion 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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

Role: STUDY_DIRECTOR

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

Locations

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Berlin, , Germany

Site Status

Harrow, , United Kingdom

Site Status

Countries

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Germany United Kingdom

References

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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.

Reference Type DERIVED
PMID: 25018015 (View on PubMed)

Related Links

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http://dx.doi.org/10.1016/j.pupt.2014.06.003

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

Other Identifiers

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40929837ASH2001

Identifier Type: OTHER

Identifier Source: secondary_id

CR017533

Identifier Type: -

Identifier Source: org_study_id