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loratadine; montelukast · 1 trial · 1 indication
| Name | Type | Description |
|---|---|---|
| loratadine; montelukast | DRUG | - |
Inclusion Criteria: * Aged 15 years or older, of either sex and of any race. * At least a 2-year documented history of SAR with symptoms during the study season. * A positive skin-prick test response to seasonal * Clinically symptomatic at Screening and at the Baseline Visits * General good health....
Loratadine/montelukast is being studied for the treatment of seasonal allergic rhinitis, commonly called hay fever. Organon & Co. is developing the combination for this respiratory indication. Seasonal allergic rhinitis involves nasal and eye symptoms triggered by seasonal allergens such as pollen.
Organon & Co. is the developer of the loratadine/montelukast combination. Organon trades on the New York Stock Exchange under the ticker OGN. The company is running the clinical development program for this seasonal allergic rhinitis candidate.
Loratadine/montelukast has been studied in Phase 3 clinical development. The program includes one completed Phase 3 trial in seasonal allergic rhinitis, and no trials are currently listed as active. It is an investigational combination and is not described as approved.
The loratadine/montelukast program includes the completed Phase 3 trial NCT00319995, titled Effects of Loratadine/Montelukast vs Pseudoephedrine and Placebo in Patients With Seasonal Allergic Rhinitis (Study P04095). It enrolled 1,095 participants aged 15 years and older, was randomized and double blind, and has completed.
Loratadine/montelukast is a small molecule combination. Loratadine is an antihistamine and montelukast is a leukotriene receptor antagonist, so the combination pairs two oral mechanisms directed at allergic airway and nasal symptoms. It is being evaluated for seasonal allergic rhinitis.
Loratadine/montelukast is a fixed combination product, not the same as the individual brand-name medicines. Loratadine is the active ingredient in Claritin, and montelukast is the active ingredient in Singulair. The combination is being developed by Organon & Co. for seasonal allergic rhinitis.