Evaluate the Potential of Montelukast to Prevent Nasal Symptomatology During Colds

This study has been completed.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
David Skoner, MD, West Penn Allegheny Health System
ClinicalTrials.gov Identifier:
NCT00189475
First received: September 13, 2005
Last updated: October 13, 2014
Last verified: October 2014
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by West Penn Allegheny Health System:

Primary Outcome Measures:
  • Nasal Secretion Weights [ Time Frame: 6 days after naturally acquiring an upper respiratory infection ] [ Designated as safety issue: No ]

Enrollment: 84
Study Start Date: October 2003
Study Completion Date: July 2007
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Montelukast
Treated for 4 months with montelukast 4 mg per day
Drug: Montelukast
Placebo Comparator: Placebo
Treated for 4 months with placebo

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
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, see Learn About Clinical Studies.

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
West Penn Allegheny Health System
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Deborah Gentile, MD West Penn Allegheny Health System
  More Information

No publications provided

Responsible Party: David Skoner, MD, Director, Allergy and Asthma Institute, West Penn Allegheny Health System
ClinicalTrials.gov Identifier: NCT00189475     History of Changes
Other Study ID Numbers: RC - 3559
Study First Received: September 13, 2005
Results First Received: September 23, 2014
Last Updated: October 13, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by West Penn Allegheny Health System:
Cold
Upper Respiratory Infection

Additional relevant MeSH terms:
Communicable Diseases
Infection
Respiratory Tract Infections
Respiratory Tract Diseases
Montelukast
Anti-Asthmatic Agents
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Leukotriene Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014