Evaluate the Potential of Montelukast to Prevent Nasal Symptomatology During Colds - Full Text View

Sponsors and Collaborators:	Allegheny General Hospital Merck
Information provided by:	Allegheny General Hospital
ClinicalTrials.gov Identifier:	NCT00189475

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.

Condition	Intervention	Phase
Upper Respiratory Infection	Drug: Montelukast	Phase IV

MedlinePlus related topics: Common Cold

Drug Information available for: Montelukast sodium Montelukast

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Double-Blind, Placebo Control, Parallel Assignment
Official Title:	A Pilot Study to Evaluate the Potential of Montelukast to Prevent the Development of Nasal Symptomatology During Natural Viral Upper Respiratory Infections

Further study details as provided by Allegheny General Hospital:

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

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00189475

Locations

United States, Pennsylvania
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212

Sponsors and Collaborators

Allegheny General Hospital

Merck

Investigators

Principal Investigator:

Deborah Gentile, MD

Allegheny General Hospital

More Information

Study ID Numbers:	RC - 3559
Study First Received:	September 13, 2005
Last Updated:	July 27, 2007
ClinicalTrials.gov Identifier:	NCT00189475
Health Authority:	United States: Institutional Review Board

Keywords provided by Allegheny General Hospital:

Cold
Upper Respiratory Infection

Study placed in the following topic categories:

Montelukast
Virus Diseases
Respiratory Tract Diseases
Respiratory Tract Infections

Common Cold
Picornaviridae Infections
Leukotriene Antagonists

Additional relevant MeSH terms:

Respiratory System Agents
Communicable Diseases
RNA Virus Infections
Therapeutic Uses
Hormone Antagonists

Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Asthmatic Agents
Infection
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009