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Also known as Budesonide, CDX-313, Captisol, Rhinocort Aqua, Astelin
Budesonide+ Azelastine · 2 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| Captisol-Enabled Budesonide + Azelastine | EXPERIMENTAL | - |
| Rhinocort Aqua+Astelin | ACTIVE_COMPARATOR | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Captisol-Enabled Budesonide | EXPERIMENTAL | 32 ug/spray |
| Rhinocort Aqua | ACTIVE_COMPARATOR | 32 ug/spray |
| Name | Type | Description |
|---|---|---|
| Budesonide + Azelastine | DRUG | nasal spray, one spray per nostril at time 0 plus one spray Placebo |
| Placebo | DRUG | nasal spray, one spray per nostril from each of 2 bottles at time 0 |
| Budesonide | DRUG | nasal spray, one spray per nostril at time 0 |
Inclusion Criteria: * Patients must have a clinical history of SAR * Adults (males and females) aged 18 to 65 * Patients must have documentation of a positive skin test within 12 months of screening to ragweed allergen defined by a positive case history and a positive skin prick and/or intradermal ...
Budesonide + Azelastine is an investigational small molecule combination therapy being developed by Ligand Pharmaceuticals Incorporated for seasonal allergic rhinitis, a respiratory condition. It pairs two active agents in a nasal solution formulation and has been studied in placebo-controlled Phase 2 clinical trials.
Budesonide + Azelastine is being developed to treat seasonal allergic rhinitis, also known as hay fever. The combination is delivered as a nasal solution and was evaluated in environmental exposure chamber studies in adult patients with seasonal allergic rhinitis. It remains investigational and is not yet an approved treatment.
Budesonide + Azelastine targets NR3C1, the glucocorticoid receptor, as an agonist. Budesonide acts on this receptor, while azelastine contributes antihistamine activity within the same nasal solution. The agonist action at NR3C1 is the mechanism associated with the budesonide component of the combination.
Ligand Pharmaceuticals Incorporated, which trades under the ticker LGND, is the developer of Budesonide + Azelastine. The company is advancing the combination nasal solution for seasonal allergic rhinitis.
Budesonide + Azelastine is in Phase 2 development. Two Phase 2 trials have been completed, and no active trials are currently listed. The asset is investigational and has not been approved by the FDA for seasonal allergic rhinitis.
Budesonide + Azelastine has been studied in two completed Phase 2 trials: NCT00940953, which compared Captisol-enabled budesonide plus azelastine nasal solution with Rhinocort Aqua plus Astelin in 108 patients, and NCT00938613, which compared CE-budesonide nasal solution with Rhinocort Aqua in 65 patients. Both were randomized, double-blind, placebo-controlled environmental exposure chamber studies conducted in Canada.
Budesonide + Azelastine is a combination product that contains budesonide along with azelastine, so it is not the same as budesonide alone. Budesonide is one of the two active components, and the combination is also referred to simply as Budesonide + Azelastine.