At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 1,992 enrolled
Drug / intervention
Montelukast +1 moredrug
Likely dose
Montelukast 10 mg orally once daily at bedtimeAI-extracted
Key inclusion· 3
- ✓Non-smoker status
- ✓2-year documented history of perennial allergic rhinitis symptoms
- ✓Positive allergy testing
Key exclusion· 2
- ✕Medical history of lung disorder (other than asthma)
- ✕Recent upper respiratory tract infection
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study Investigating the Clinical Effects of Montelukast in Patients With Perennial Allergic Rhinitis
In Brief
A Phase 3 clinical trial evaluating Montelukast and Comparator: Placebo for Rhinitis, Allergic, Perennial. Completed, enrolled 1,992 participants.
Detailed Summary
The purpose of this study is to determine the effect of an approved medication on the symptoms of perennial allergic rhinitis (an inflammation of the mucous membrane of the nose similar to that found in hay fever except that symptoms persist throughout the year), in patients who have a history of perennial allergic rhinitis.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRhinitis, Allergic, Perennial
Countries--
Collaborators--
Timeline
Phase 3CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartOct 2003
Primary CompletionMay 2004
First PostedSep 2004
TodayJul 2026
First PostedSep 24, 2004
Enrollment StartOct 1, 2003
Primary CompletionMay 1, 2004
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 21.8 years ago
Interventions
Montelukastdrug
one 10 mg tablet, taken once daily at bed time for 6 weeks
Comparator: Placebodrug
one placebo tablet, taken once daily at bed time for 6 weeks