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

Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01241422
• Other study ID #: CR017533
• Secondary ID: 40929837ASH2001
• Status: Completed
• Phase: Phase 2
• First received: October 25, 2010
• Last updated: December 18, 2015
• Start date: November 2010
• Est. completion date: June 2011

Study information

• Verified date: December 2015
• Source: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical DevicesUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• 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.
• 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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Countries where clinical trial is conducted

Germany,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Change in FEV1 during the early response to allergen		0-2 hours after allergen exposure on Day 6 of each treatment period	No
Secondary	Area under the FEV1/time curve during the early response to allergen		Between 0 and 2 hours post allergen challenge on Day 6	No
Secondary	Area under the FEV1/time curve during the late response to allergen		Between 3 and 10 hours post allergen challenge on Day 6	No
Secondary	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	No
Secondary	Sputum leukotriene B4 levels	This biomarker will be measured as a pharmacodynamic evaluation.	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	No
Secondary	Plasma leukotriene B4 levels	This biomarker will be measured as a pharmacodynamic evaluation.	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	No

External Links

•   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