NCT04264637 is a Phase 3 clinical trial of Azelastine hydrochloride (BAYR9258) in Allergic Rhinitis, sponsored by Bayer.

Who is sponsoring NCT04264637?

NCT04264637 is sponsored by Bayer.

What drugs are being tested in NCT04264637?

Interventions in NCT04264637: Azelastine hydrochloride (BAYR9258), Placebo.

What condition does NCT04264637 study?

NCT04264637 studies Allergic Rhinitis.

Is NCT04264637 still recruiting?

NCT04264637 is currently completed. Last updated 25 March 2022.

Last reviewed 2022-03-25 · How we verify

NCT04264637

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Study to Find Out How Long it Takes Azelastine Hydrochloride 0.15% Nasal Spray to Relieve Symptoms in Patients Suffering From Allergic Rhinitis

Completed Phase 3 Last updated 25 March 2022

What this trial tests

Phase 3 trial testing Azelastine hydrochloride (BAYR9258) in Allergic Rhinitis in 110 participants. Completed in 17 March 2021.

Timeline

3 February 2020

Primary endpoint
17 March 2021

17 March 2021

Quick facts

Lead sponsor	Bayer
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	double
Primary purpose	treatment
Enrollment	110
Start date	3 February 2020
Primary completion	17 March 2021
Estimated completion	17 March 2021
Sites	1 location across Canada

Drugs / interventions tested

Azelastine hydrochloride (BAYR9258) — full drug profile →
Placebo

Conditions studied

Allergic Rhinitis — all drugs for Allergic Rhinitis →

Sponsor

Bayer — full company profile →

Who can join

Adults 18 to 65, any sex, with Allergic Rhinitis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

In this study researchers want to learn how quickly patients suffering from allergic rhinitis (also known as hay fever) can expect symptom relief after using Azelastine Hydrochloride 0.15% Nasal Spray. This study plans to enrol about 80 male or female participants in the age of 18 to 65 years suffering from an allergic rhinitis to ragweed pollen for at least 2 years. In a first phase participants will be exposed to ragweed pollen in a special study room to ensure they will be adequately symptomatic when they progress into the treatment phase of the study. In a second phase study participants will be divided in 2 groups. After exposure to ragweed pollen one group will receive Azelastine Hydrochloride 0.15% Nasal Spray and the other group will receive placebo (a nasal spray which does not contain any active drug substance). In the third phase of study the treatment will be switched: participants who received in the previous study Azelastine Hydrochloride 0.15% Nasal Spray will receive the nasal spray without any active drug substance and the other group will receive Azelastine Hydrochloride 0.15% Nasal Spray. During the second and third study phase the researchers will examine thoroughly over 4 hours the change of nasal symptoms such as runny nose, itchy nose, sneezing and nasal congestion after participants received the nasal spray.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Allergic Rhinitis

Currently open trials in the same condition.

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NCT07455968 — Free Diving Breathing Training in Allergic Rhinitis · NA · active not recruiting
NCT07115342 — Effect of Combined Probiotics and Vitamin D on Symptoms of Allergic Rhinitis · NA · recruiting

Other Bayer trials

Trials by the same sponsor.

NCT05900388 — A Study to Observe the Pattern of Use and Safety of Rivaroxaban in Children Under 2 Years Old With Venous Thromboembolis · not yet recruiting
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NCT05477953 — An Observational Pregnancy Safety Study in Women Who Were Exposed to the Drug Nifurtimox During Pregnancy to Learn About · not yet recruiting
NCT07192952 — A Study to Learn More About How Safe Finerenone is, When it is Taken for a Longer Time With Standard Treatment, in Child · Phase 3 · not yet recruiting
NCT07450599 — A Study to Learn How Well a Combination of Darolutamide and Androgen Deprivation Therapy (ADT) Works as a Treatment Befo · Phase 2 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04264637 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Bayer
Last refreshed: 25 March 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04264637.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing