Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Evaluate the Potential of Montelukast to Prevent Nasal Symptomatology During Colds

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00189475
Recruitment Status : Completed
First Posted : September 19, 2005
Results First Posted : October 17, 2014
Last Update Posted : November 18, 2020
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Deborah Gentile, West Penn Allegheny Health System

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Upper Respiratory Infection Drug: Montelukast Drug: Placebo Phase 4

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: A Pilot Study to Evaluate the Potential of Montelukast to Prevent the Development of Nasal Symptomatology During Natural Viral Upper Respiratory Infections
Study Start Date : October 2003
Actual Primary Completion Date : July 2007
Actual Study Completion Date : July 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Montelukast

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Active Comparator: Montelukast
Treated for 4 months with montelukast 4 mg per day
 Drug: Montelukast
Placebo Comparator: Placebo
Treated for 4 months with placebo
 Drug: Placebo


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Nasal Secretion Weights [ Time Frame: 6 days after naturally acquiring an upper respiratory infection ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00189475


Locations
Layout table for location information
United States, Pennsylvania
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212
Sponsors and Collaborators
Deborah Gentile
Merck Sharp & Dohme Corp.
Investigators
Layout table for investigator information
Principal Investigator: Deborah Gentile, MD West Penn Allegheny Health System
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Deborah Gentile, Physician , Allergy and Asthma Institute, West Penn Allegheny Health System
ClinicalTrials.gov Identifier: NCT00189475    
Other Study ID Numbers: RC - 3559
First Posted: September 19, 2005    Key Record Dates
Results First Posted: October 17, 2014
Last Update Posted: November 18, 2020
Last Verified: October 2020
Keywords provided by Deborah Gentile, West Penn Allegheny Health System:
Cold
Upper Respiratory Infection
Additional relevant MeSH terms:
Layout table for MeSH terms
Infections
Respiratory Tract Infections
Respiratory Tract Diseases
Montelukast
Anti-Asthmatic Agents
Respiratory System Agents
Leukotriene Antagonists
 Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP1A2 Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action