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Azelastine

Phase 3

Allergic Rhinitis | Small molecule | Respiratory |Bayer AG|Last Updated: Mar 25, 2022

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment110

FDA Designations

No designations recorded

Clinical trial landscape

Azelastine · 1 trial · 1 indication

Phase 3 1
NCT04264637Study to Find Out How Long it Takes Azelastine Hydrochloride 0.15% Nasal Spray to Relieve Symptoms in Patients Suffering From Allergic RhinitisAllergic Rhinitis
COMPLETED110 Analytics
PHASE3COMPLETED
Study to Find Out How Long it Takes Azelastine Hydrochloride 0.15% Nasal Spray to Relieve Symptoms in Patients Suffering From Allergic Rhinitis
Allergic RhinitisUnlock trial analytics

Study Endpoints

Primary Endpoints

Total nasal symptom score (TNSS)
4 hours post dose

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)

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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Azelastine hydrochloride 0.15% + PlaceboEXPERIMENTALEach 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%EXPERIMENTALEach 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.

Interventions

NameTypeDescription
Azelastine hydrochloride (BAYR9258)DRUGSingle dose, metered-spray solution, 2 sprays per nostril, 205.5 mcg/spray, intranasal administration.
PlaceboDRUGSingle dose of Azelastine hydrochloride-matched placebo, metered-spray solution, 2 sprays per nostril, intranasal administration.
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

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...

Countries:Canada
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Competitive Landscape -Allergic Rhinitis 4 trials

Frequently asked questions about Azelastine

What is Azelastine used for?

Azelastine is used for the treatment of Allergic Rhinitis. It is administered as a nasal spray, specifically Azelastine Hydrochloride 0.15% Nasal Spray, and is being studied to determine how quickly it relieves symptoms in patients suffering from this condition.

What does Azelastine target?

Azelastine is a small molecule that targets histamine receptors. As an antihistamine, it works by blocking the effects of histamine, a substance in the body that causes allergic symptoms such as sneezing, itching, and a runny nose, thereby providing relief from allergic rhinitis symptoms.

Who makes Azelastine?

Azelastine is being developed by Bayer AG, a multinational pharmaceutical company. Bayer AG is listed on the stock exchange under the ticker symbol BAYRY.

What phase is Azelastine in?

Azelastine is currently in Phase 3 clinical development. It is an investigational drug for the treatment of Allergic Rhinitis and has not yet been approved by regulatory authorities. The Phase 3 trial has been completed.

What clinical trials is Azelastine in?

Azelastine is being studied in a Phase 3 clinical trial with the identifier NCT04264637. This trial, titled 'Study to Find Out How Long it Takes Azelastine Hydrochloride 0.15% Nasal Spray to Relieve Symptoms in Patients Suffering From Allergic Rhinitis,' enrolled 110 participants in Canada. The trial was randomized, double-blind, and controlled, and it has been completed.

Is Azelastine the same as Azelastine Hydrochloride?

Azelastine is the active ingredient in the medication Azelastine Hydrochloride. The drug is formulated as a nasal spray containing Azelastine Hydrochloride 0.15%, which is the specific form used in the clinical trial for Allergic Rhinitis.