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

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. |
- 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 ]
- Change in FEV1 during the early response to allergen [ Time Frame: 0-2 hours after allergen exposure on Day 6 of each treatment period ]
- 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 ]
- 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 ]
- 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 ]
- 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.
- 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.

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Ages Eligible for Study: | 18 Years to 55 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |

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
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. |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 |
Asthma Mild asthma Singulair JNJ 40929837 Montelukast |
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 |