Evaluate the Potential of Montelukast to Prevent Nasal Symptomatology During Colds
Overview[ - collapse ][ - ]
Purpose | Assesses the efficacy of treatment with montelukast 10 mg PO QD x 5 days versus placebo for the treatment of viral-induced upper respiratory infection in healthy adults aged 18-50 years. |
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Condition | Upper Respiratory Infection |
Intervention | Drug: Montelukast |
Phase | Phase 4 |
Sponsor | West Penn Allegheny Health System |
Responsible Party | West Penn Allegheny Health System |
ClinicalTrials.gov Identifier | NCT00189475 |
First Received | September 13, 2005 |
Last Updated | July 27, 2007 |
Last verified | July 2007 |
Tracking Information[ + expand ][ + ]
First Received Date | September 13, 2005 |
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Last Updated Date | July 27, 2007 |
Start Date | Not Provided |
Estimated Primary Completion Date | Not Provided |
Current Primary Outcome Measures | Not Provided |
Current Secondary Outcome Measures | Not Provided |
Descriptive Information[ + expand ][ + ]
Brief Title | Evaluate the Potential of Montelukast to Prevent Nasal Symptomatology During Colds |
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Official Title | A Pilot Study to Evaluate the Potential of Montelukast to Prevent the Development of Nasal Symptomatology During Natural Viral Upper Respiratory Infections |
Brief Summary | Assesses the efficacy of treatment with montelukast 10 mg PO QD x 5 days versus placebo for the treatment of viral-induced upper respiratory infection in healthy adults aged 18-50 years. |
Detailed Description | This is a randomized double-blinded placebo controlled trial to assess the efficacy of treatment with montelukast 10 mg PO QD x 5 days versus placebo for the treatment of viral-induced upper respiratory infection in healthy adults aged 18-50 years. All subjects complete daily assessments of cold symptoms, nasal clearance rates and secretion rates during each day of the study. Phlebotomy is performed once for the determination of cytokine genotyping and allergy skin testing is performed once for the assessment of atopy. |
Study Type | Interventional |
Study Phase | Phase 4 |
Study Design | Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind |
Condition | Upper Respiratory Infection |
Intervention | Drug: Montelukast |
Study Arm (s) | Not Provided |
Recruitment Information[ + expand ][ + ]
Recruitment Status | Completed |
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Estimated Enrollment | Not Provided |
Estimated Completion Date | Not Provided |
Estimated Primary Completion Date | Not Provided |
Eligibility Criteria | Inclusion Criteria: - Adults 18 to 50 years of age. - Male or female, who are not pregnant or lactating. - Common cold symptoms for less than 24 hours. - At least 2 of the following 9 symptoms: cough, headache, hoarseness, muscle ache, nasal drainage, nasal congestion, scratch throat, sneezing and malaise. Exclusion Criteria: - Investigational medication in past 30 days. - Known hypersensitivity to any ingredients in study medication. - History of asthma or other chronic diseases. - Females of childbearing potential who are not using a medically acceptable form of birth control. - Patients with nasal ulcers within the past 1 month, nasal surgery within the past 6 months, nasal trauma within the past 2 months or presence of nasal polyps or nasal deformities causing significant nasal obstruction. - Females with a positive urinary HCG test. - Patients with a positive rapid antigen test for streptococcal infection. - Common cold symptoms for more than 24 hours. - Patients who are users of illicit drugs. - Patients who are on rifampin or phenobarbital. |
Gender | Both |
Ages | 18 Years |
Accepts Healthy Volunteers | No |
Contacts | Not Provided |
Location Countries | United States |
Administrative Information[ + expand ][ + ]
NCT Number | NCT00189475 |
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Other Study ID Numbers | RC - 3559 |
Has Data Monitoring Committee | Not Provided |
Information Provided By | West Penn Allegheny Health System |
Study Sponsor | West Penn Allegheny Health System |
Collaborators | Merck Sharp & Dohme Corp. |
Investigators | Principal Investigator: Deborah Gentile, MD West Penn Allegheny Health System |
Verification Date | July 2007 |
Locations[ + expand ][ + ]
Allegheny General Hospital | Pittsburgh, Pennsylvania, United States, 15212 |
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