The Safety and Effectiveness of MK0476 (Montelukast) in Patients With Chronic Asthma
Overview[ - collapse ][ - ]
| Purpose | This study will test the safety and effectiveness of a range of doses of MK0476 (montelukast) compared to placebo on improved lung function in patients with chronic asthma. |
|---|---|
| Condition | Chronic Asthma |
| Intervention | Drug: Comparator: montelukast Drug: Comparator: placebo |
| Phase | Phase 1 |
| Sponsor | Merck Sharp & Dohme Corp. |
| Responsible Party | Merck Sharp & Dohme Corp. |
| ClinicalTrials.gov Identifier | NCT00739297 |
| First Received | August 19, 2008 |
| Last Updated | April 21, 2010 |
| Last verified | April 2010 |
Tracking Information[ + expand ][ + ]
| First Received Date | August 19, 2008 |
|---|---|
| Last Updated Date | April 21, 2010 |
| Start Date | July 2008 |
| Estimated Primary Completion Date | January 2009 |
| Current Primary Outcome Measures | Change From Baseline in FEV1 Over 4 Hours [Time Frame: 0 (=baseline) to 4 hours after treatment with montelukast] [Designated as safety issue: No]FEV1 measurements taken at 0 (=baseline), 10, 20, 30, 45, 60, 120, 180 and 240 minutes contributed to the average change from baseline over 4 hours. The number of minutes between consecutive measurements was used as weighting factor. The time-weighted average change was standardized by dividing by the time associated with the last measurement. |
| Current Secondary Outcome Measures | Change From Baseline in FEV1 Over 90 Minutes After Albuterol/Placebo Administration [Time Frame: 4 hours (equals time point at which albuterol or albuterol placebo is administered) to 5.5 hours after treatment with montelukast] [Designated as safety issue: No]FEV1 measurements taken at 0 (=baseline), 15, 30, 60, and 90 minutes after albuterol/placebo administration contributed to the average change from baseline over 90 minutes. The number of minutes between consecutive measurements was used as weighting factor. The time-weighted average change was standardized by dividing by the time associated with the last measurement. |
Descriptive Information[ + expand ][ + ]
| Brief Title | The Safety and Effectiveness of MK0476 (Montelukast) in Patients With Chronic Asthma |
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| Official Title | A Phase Ib Randomized, Placebo-Controlled Clinical Trial to Study the Safety and Bronchodilatory Effect of MK0476 in Patients With Chronic Asthma |
| Brief Summary | This study will test the safety and effectiveness of a range of doses of MK0476 (montelukast) compared to placebo on improved lung function in patients with chronic asthma. |
| Detailed Description | Not Provided |
| Study Type | Interventional |
| Study Phase | Phase 1 |
| Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment |
| Condition | Chronic Asthma |
| Intervention | Drug: Comparator: montelukast 5 Period, Cross-over, Dose-Ranging study. Period I: no treatment. Periods II-V: Single-dose administration of inhaled montelukast (using doses as low as 25 mcg, to as high as 1000 mcg), or montelukast placebo. Two puffs of albuterol or albuterol placebo will be given four hours after montelukast/montelukast placebo. Other Names: SINGULAIR®, PROAIR® HFADrug: Comparator: placebo 5 Period, Cross-over, Dose-Ranging study. Period I: no treatment. Periods II-V: Single-dose administration of inhaled montelukast (using doses as low as 25 mcg, to as high as 1000 mcg), or montelukast placebo. Two puffs of albuterol or albuterol placebo will be given four hours after montelukast/montelukast placebo. |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 68 |
| Estimated Completion Date | January 2009 |
| Estimated Primary Completion Date | December 2008 |
| Eligibility Criteria | Inclusion Criteria: - A person is 15 to 65 years of age. A person has had chronic asthma for at least one year Exclusion Criteria: - A person is a smoker or has smoked more that a pack a day for more than 10 years before stopping - A person has other lung disorders such as COPD (chronic obstructive pulmonary disorder) |
| Gender | Both |
| Ages | 15 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | Not Provided |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00739297 |
|---|---|
| Other Study ID Numbers | 2008_542 |
| Has Data Monitoring Committee | Not Provided |
| Information Provided By | Merck Sharp & Dohme Corp. |
| Study Sponsor | Merck Sharp & Dohme Corp. |
| Collaborators | Not Provided |
| Investigators | Study Director: Medical Monitor Merck Sharp & Dohme Corp. |
| Verification Date | April 2010 |