Evaluate the Potential of Montelukast to Prevent Nasal Symptomatology During Colds

Completed · Phase 4 · Has a placebo group

Conditions studied: Upper Respiratory Infection

In brief

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.

Key facts

Study ID

NCT00189475

Run by

Deborah Gentile

People needed

84

Starts

2003-10-01

Expected to finish

2007-07-01

Last updated by the study team

2020-11-18

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Allegheny General Hospital — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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