Evaluate the Potential of Montelukast to Prevent Nasal Symptomatology During Colds

Upper Respiratory Infection Clinical Trial

Official title:

A Pilot Study to Evaluate the Potential of Montelukast to Prevent the Development of Nasal Symptomatology During Natural Viral Upper Respiratory Infections

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00189475
• Other study ID #: RC - 3559
• Status: Completed
• Phase: Phase 4
• 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
• 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.

Related Conditions & MeSH terms

• Infection
• Respiratory Tract Infections
• Upper Respiratory Infection

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