Evaluate the Potential of Montelukast to Prevent Nasal Symptomatology During Colds

NCT00189475 | Completed Phase 4 Results

• 1 other identifier: RC - 3559
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Upper Respiratory Infection

Keywords

Cold; Upper Respiratory Infection

Outcome Measures

Primary Outcomes (1)

• Nasal Secretion Weights

  6 days after naturally acquiring an upper respiratory infection

Study Arms (2)

Montelukast

ACTIVE COMPARATOR

Treated for 4 months with montelukast 4 mg per day

Drug: Montelukast

Placebo

PLACEBO COMPARATOR

Treated for 4 months with placebo

Drug: Placebo

Interventions

Montelukast DRUG

Montelukast

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Deborah Gentile: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

Location

MeSH Terms

Conditions

Respiratory Tract Infections; Common Cold

Interventions

montelukast

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases; Picornaviridae Infections; RNA Virus Infections; Virus Diseases

Results Point of Contact

• Title: David Skoner, MD
• Organization: Allegheny Singer Research Institute, WPAHS

dskoner@wpahs.org

4123594099

Study Officials

• Deborah Gentile, MD

  West Penn Allegheny Health System

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Physician , Allergy and Asthma Institute

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 19, 2005
• Study Start: October 1, 2003
• Primary Completion: July 1, 2007
• Study Completion: July 1, 2007
• Last Updated: November 18, 2020
• Results First Posted: October 17, 2014

Record last verified: 2020-10

Locations

US (1)