Phase 4
N=84
Evaluate the Potential of Montelukast to Prevent Nasal Symptomatology During Colds
Upper Respiratory Infection
Bottom Line
View on ClinicalTrials.gov: NCT00189475 ↗Enrolled (actual)
84
Serious AEs
0.0%
Results posted
Oct 2014
Primary outcome: Primary: Nasal Secretion Weights — 3.5; 4.2; 1.2; 2.6 grams
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Montelukast (Drug); Placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Deborah Gentile
- Primary completion
- Jul 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Nasal Secretion Weights |
3.5; 4.2; 1.2; 2.6 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT00189475). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.