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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00189475
Other study ID # RC - 3559
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date October 2003
Est. completion date July 2007

Study information

Verified date October 2020
Source West Penn Allegheny Health System
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 84
Est. completion date July 2007
Est. primary completion date July 2007
Accepts healthy volunteers No
Gender All
Age group 18 Years to 50 Years
Eligibility 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.

Study Design


Intervention

Drug:
Montelukast

Placebo


Locations

Country Name City State
United States Allegheny General Hospital Pittsburgh Pennsylvania

Sponsors (2)

Lead Sponsor Collaborator
Deborah Gentile Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Nasal Secretion Weights 6 days after naturally acquiring an upper respiratory infection
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