A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Inhaled Montelukast (MK-0476) in Participants With Mild or Moderate Asthma (MK-0476-380 AM3)(COMPLETED)
Overview[ - collapse ][ - ]
Purpose | A study to evaluate the safety, tolerability and pharmacokinetics of inhaled Montelukast (MK-0476) in participants with mild or moderate asthma. |
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Condition | Asthma |
Intervention | Drug: Montelukast Drug: Placebo |
Phase | Phase 1 |
Sponsor | Merck Sharp & Dohme Corp. |
Responsible Party | Merck Sharp & Dohme Corp. |
ClinicalTrials.gov Identifier | NCT00636207 |
First Received | March 3, 2008 |
Last Updated | November 22, 2013 |
Last verified | November 2013 |
Tracking Information[ + expand ][ + ]
First Received Date | March 3, 2008 |
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Last Updated Date | November 22, 2013 |
Start Date | August 2007 |
Estimated Primary Completion Date | October 2008 |
Current Primary Outcome Measures |
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Current Secondary Outcome Measures | Not Provided |
Descriptive Information[ + expand ][ + ]
Brief Title | A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Inhaled Montelukast (MK-0476) in Participants With Mild or Moderate Asthma (MK-0476-380 AM3)(COMPLETED) |
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Official Title | A Sequential, 3-Part, Double-Blind, Randomized, Placebo-Controlled, Single-Rising-Dose and Rising-Multiple-Dose Study in Healthy Subjects and Mild or Moderate Asthmatic Patients to Evaluate the Safety, Tolerability, and Pharmacokinetics of Inhaled MK-0476 |
Brief Summary | A study to evaluate the safety, tolerability and pharmacokinetics of inhaled Montelukast (MK-0476) in participants with mild or moderate asthma. |
Detailed Description | Not Provided |
Study Type | Interventional |
Study Phase | Phase 1 |
Study Design | Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment |
Condition | Asthma |
Intervention | Drug: Montelukast Montelukast dry powder inhaler, 0.1 mg, 0.3 mg, 1 mg, 3 mg or 10 mg Other Names:
Placebo dry powder inhaler |
Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Completed |
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Estimated Enrollment | 46 |
Estimated Completion Date | October 2008 |
Estimated Primary Completion Date | September 2008 |
Eligibility Criteria | Inclusion Criteria: - Male or female between the ages of 18 and 65 - Must have mild or moderate asthma (Part III only) - Nonsmoker for at least 6 months Exclusion Criteria: - History of stroke, chronic seizures or major neurological disorder - You are nursing - Drink more than 3 glasses of alcohol a day - Have allergy to or not able to tolerate lactose - Have a history of drug abuse in the last 5 years - Drink more than 6 beverages containing caffeine a day - Have had surgery, donated blood or participated in another investigational study in the last 4 weeks |
Gender | Both |
Ages | 18 Years |
Accepts Healthy Volunteers | No |
Contacts | Not Provided |
Location Countries | Not Provided |
Administrative Information[ + expand ][ + ]
NCT Number | NCT00636207 |
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Other Study ID Numbers | 0476-380 |
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 | November 2013 |