Evaluate the Potential of Montelukast to Prevent Nasal Symptomatology During Colds

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Primary Purpose

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Montelukast

Placebo

About this trial

This is an interventional prevention trial for Upper Respiratory Infection focused on measuring Cold, Upper Respiratory Infection

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Allegheny General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Montelukast

Placebo

Arm Description

Treated for 4 months with montelukast 4 mg per day

Treated for 4 months with placebo

Outcomes

Primary Outcome Measures

Nasal Secretion Weights

Secondary Outcome Measures

Full Information

NCT ID

NCT00189475

First Posted

September 13, 2005

Last Updated

October 30, 2020

Sponsor

Deborah Gentile

Collaborators

Merck Sharp & Dohme LLC

1. Study Identification

Unique Protocol Identification Number

NCT00189475

Brief Title

Evaluate the Potential of Montelukast to Prevent Nasal Symptomatology During Colds

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 Type

Interventional

2. Study Status

Record Verification Date

October 2020

Overall Recruitment Status

Completed

Study Start Date

October 2003 (undefined)

Primary Completion Date

July 2007 (Actual)

Study Completion Date

July 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Deborah Gentile

Collaborators

Merck Sharp & Dohme LLC

4. Oversight

Data Monitoring Committee

No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Upper Respiratory Infection

Keywords

Cold, Upper Respiratory Infection

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

84 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Montelukast

Arm Type

Active Comparator

Arm Description

Treated for 4 months with montelukast 4 mg per day

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Treated for 4 months with placebo

Intervention Type

Drug

Intervention Name(s)

Montelukast

Intervention Type

Drug

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

Nasal Secretion Weights

Time Frame

6 days after naturally acquiring an upper respiratory infection

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

No

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Deborah Gentile, MD

Organizational Affiliation

West Penn Allegheny Health System

Official's Role

Principal Investigator

Facility Information:

Facility Name

Allegheny General Hospital

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15212

Country

United States

Upper Respiratory Infection

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

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