At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 84 enrolled
Drug / intervention
Montelukast +1 moredrug
Likely dose
Not stated in record
Key inclusion· 4
- ✓Age 18 to 50 years
- ✓Male or female, not pregnant or lactating
- ✓Common cold symptoms onset less than 24 hours prior
- ✓At least 2 of these 9 symptoms: cough, headache, hoarseness, muscle ache, nasal drainage, nasal congestion, scratch throat, sneezing, or malaise
Key exclusion· 8
- ✕History of asthma or other chronic diseases
- ✕Nasal ulcers within past 1 month, nasal surgery within past 6 months, nasal trauma within past 2 months, or nasal polyps/deformities causing significant obstruction
- ✕Positive rapid antigen test for streptococcal infection
- ✕Common cold symptoms for more than 24 hours
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Pilot Study to Evaluate the Potential of Montelukast to Prevent the Development of Nasal Symptomatology During Natural Viral Upper Respiratory Infections
In Brief
A Phase 4 clinical trial evaluating Montelukast and Placebo for Upper Respiratory Infection. Completed, enrolled 84 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUpper Respiratory Infection
CountriesUnited States
CollaboratorsMerck Sharp & Dohme LLC
Timeline
Phase 4CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartOct 2003
First PostedSep 2005
Primary CompletionJul 2007
TodayJul 2026
First PostedSep 19, 2005
Enrollment StartOct 1, 2003
Primary CompletionJul 1, 2007
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 20.8 years ago
Interventions
Montelukastdrug
Placebodrug