Evaluate the Potential of Montelukast to Prevent Nasal Symptomatology During Colds

Phase 4

Completed

• Conditions: Upper Respiratory Infection
• Interventions: Drug: Placebo; Drug: Montelukast

• Registration Number: NCT00189475
• Lead Sponsor: Deborah Gentile

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 Timeline

• Study Start: 2003-10
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-19
• Primary Completion: 2007-07
• Study Completion: 2007-07
• Results First Submitted: 2014-09-23
• Results First Submitted QC: 2014-10-13
• Results First Posted: 2014-10-17
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-30
• Last Update Posted: 2020-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Treated for 4 months with placebo
Montelukast	Montelukast	Treated for 4 months with montelukast 4 mg per day

Primary Outcome Measures

Name	Time	Method
Nasal Secretion Weights	6 days after naturally acquiring an upper respiratory infection

Trial Locations

Locations (1)

Allegheny General Hospital; 🇺🇸 Pittsburgh, Pennsylvania, United States