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Also known as Azelastine hydrochloride (BAYR9258)
Azelastine · 1 trial · 1 indication
Evaluated by rating the following symptoms (sneezing, runny nose, itchy nose, and nasal congestion) on a scale from 0-3 (0 = None, 1= Mild symptoms, 2 = Moderate symptoms, 3 = Severe symptoms)
| Arm | Type | Description |
|---|---|---|
| Azelastine hydrochloride 0.15% + Placebo | EXPERIMENTAL | Each participant will receive a single dose (two sprays per nostril) of study intervention Azelastine hydrochloride 0.15% and Placebo at treatment period 1 and 2 respectively. |
| Placebo + Azelastine hydrochloride 0.15% | EXPERIMENTAL | Each participant will receive a single dose (two sprays per nostril) of study intervention Placebo and Azelastine hydrochloride 0.15% at treatment period 1 and 2 respectively. |
| Name | Type | Description |
|---|---|---|
| Azelastine hydrochloride (BAYR9258) | DRUG | Single dose, metered-spray solution, 2 sprays per nostril, 205.5 mcg/spray, intranasal administration. |
| Placebo | DRUG | Single dose of Azelastine hydrochloride-matched placebo, metered-spray solution, 2 sprays per nostril, intranasal administration. |
Inclusion Criteria: * Healthy, ambulatory, male or female volunteers 18 to 65 years of age with selfreported allergic rhinitis to ragweed pollen for at least 2 years prior. * Documented positive skin prick test response to common ragweed (ambrosia artemisiifolia) pollen; prick with wheal ≥3 mm larg...
Top 1 of 3 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Eli Lilly and Company | LLY | 1 | PHASE3 | LY3650150 |
Azelastine is being developed for the treatment of allergic rhinitis. It is an investigational small molecule studied in adults 18 years and older. A Phase 3 trial evaluated how quickly azelastine hydrochloride 0.15% nasal spray relieves allergic rhinitis symptoms in patients.
Azelastine is an antagonist of HRH1, the histamine H1 receptor. By blocking HRH1, azelastine interferes with histamine signaling that drives allergic rhinitis symptoms. This targeted antagonism is the basis for its development as a small molecule therapy for allergic rhinitis.
Azelastine is developed by Bayer AG, which trades under the ticker BAYRY. Bayer is the sponsor of the clinical program evaluating azelastine hydrochloride 0.15% nasal spray for allergic rhinitis.
Azelastine is in Phase 3 development for allergic rhinitis. The completed Phase 3 trial enrolled 110 participants. Azelastine is investigational and has not been approved for this use based on the available development information.
Azelastine has been studied in the Phase 3 trial NCT04264637, titled "Study to Find Out How Long it Takes Azelastine Hydrochloride 0.15% Nasal Spray to Relieve Symptoms in Patients Suffering From Allergic Rhinitis." The trial was completed, enrolled 110 participants, and was conducted in Canada.
Yes, Azelastine is also known as azelastine hydrochloride (BAYR9258). These names refer to the same small molecule being developed by Bayer AG for allergic rhinitis.