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.
ConditionUpper Respiratory Infection
InterventionDrug: Montelukast
PhasePhase 4
SponsorWest Penn Allegheny Health System
Responsible PartyWest Penn Allegheny Health System
ClinicalTrials.gov IdentifierNCT00189475
First ReceivedSeptember 13, 2005
Last UpdatedJuly 27, 2007
Last verifiedJuly 2007

Tracking Information[ + expand ][ + ]

First Received DateSeptember 13, 2005
Last Updated DateJuly 27, 2007
Start DateNot Provided
Estimated Primary Completion DateNot Provided
Current Primary Outcome MeasuresNot Provided
Current Secondary Outcome MeasuresNot Provided

Descriptive Information[ + expand ][ + ]

Brief TitleEvaluate the Potential of Montelukast to Prevent Nasal Symptomatology During Colds
Official TitleA 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 TypeInterventional
Study PhasePhase 4
Study DesignAllocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind
ConditionUpper Respiratory Infection
InterventionDrug: Montelukast
Study Arm (s)Not Provided

Recruitment Information[ + expand ][ + ]

Recruitment StatusCompleted
Estimated EnrollmentNot Provided
Estimated Completion DateNot Provided
Estimated Primary Completion DateNot 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.
GenderBoth
Ages18 Years
Accepts Healthy VolunteersNo
ContactsNot Provided
Location CountriesUnited States

Administrative Information[ + expand ][ + ]

NCT Number NCT00189475
Other Study ID NumbersRC - 3559
Has Data Monitoring CommitteeNot Provided
Information Provided ByWest Penn Allegheny Health System
Study SponsorWest Penn Allegheny Health System
CollaboratorsMerck Sharp & Dohme Corp.
Investigators Principal Investigator: Deborah Gentile, MD West Penn Allegheny Health System
Verification DateJuly 2007

Locations[ + expand ][ + ]

Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212