Evaluate the Potential of Montelukast to Prevent Nasal Symptomatology During Colds
Information source: Allegheny General Hospital
Information obtained from ClinicalTrials.gov on March 21, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Upper Respiratory Infection
Intervention: Montelukast (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Allegheny General Hospital Official(s) and/or principal investigator(s):
Deborah Gentile, MD, Principal Investigator, Affiliation: Allegheny General Hospital
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.
Clinical Details
Official title: A Pilot Study to Evaluate the Potential of Montelukast to Prevent the Development of Nasal Symptomatology During Natural Viral Upper Respiratory Infections
Study design: Randomized, Double-Blind, Placebo Control, Parallel Assignment
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 50 Years.
Gender(s): Both.
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.
Locations and Contacts
Allegheny General Hospital, Pittsburgh, Pennsylvania 15212, United States
Additional Information
Last updated: July 27, 2007
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