A Study to Evaluate the Effectiveness of JNJ 40929837 for the Treatment of Asthma Using a Bronchial Allergen Challenge Model
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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 | Intervention | Phase |
|---|---|---|
|
Asthma |
Drug: JNJ 40929837 Drug: Placebo Drug: Montelukast |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, 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 |
- 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 ]
- 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.
| Enrollment: | 22 |
| Study Start Date: | November 2010 |
| Study Completion Date: | June 2011 |
| Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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 LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01241422
| Germany | |
| Berlin, Germany | |
| United Kingdom | |
| Harrow, United Kingdom | |
| Study Director: | Johnson & Johnson Pharmaceutical Research & Development, L.L C. Clinical Trial | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
More Information
Additional Information:
No publications provided
| Responsible Party: | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
| ClinicalTrials.gov Identifier: | NCT01241422 History of Changes |
| Other Study ID Numbers: | CR017533, 40929837ASH2001 |
| Study First Received: | October 25, 2010 |
| Last Updated: | August 28, 2014 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
|
Asthma Mild asthma Singulair JNJ 40929837 Montelukast |
Additional relevant MeSH terms:
|
Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases |
Montelukast Anti-Asthmatic Agents Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Leukotriene Antagonists Pharmacologic Actions Physiological Effects of Drugs Respiratory System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on February 27, 2015