Randomized Multicenter Phase III Efficacy and Safety Study of AI201901 in Allergic Rhinitis Patients (HILARIA)

Abdi Ibrahim Ilac San. ve Tic A.S.1 site in 1 country210 target enrollmentApril 20, 2021

ConditionsAllergic Rhinitis Due to Allergens

InterventionsAzelastine Hydrochloride AI201901

DrugsAI201901 Azelastine Hydrochloride

Overview

Phase: Phase 3
Intervention: Azelastine Hydrochloride
Conditions: Allergic Rhinitis Due to Allergens
Sponsor: Abdi Ibrahim Ilac San. ve Tic A.S.
Enrollment: 210
Locations: 1
Primary Endpoint: Total Nasal Symptom Score
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a prospective, national, randomized, multicenter, parallel group, Phase III study that evaluates the effects of AI201901 in Allergic Rhinitis patients, where they will spray twice a day against azelastine into both nostrils during a 28-day follow-up period.

Registry

clinicaltrials.gov

Start Date

April 20, 2021

End Date

May 2, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Abdi Ibrahim Ilac San. ve Tic A.S.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•To be diagnosed as allergic rhinitis on the basis of medical history, physical examination, and skin prick test, and according to ARIA 2008 criteria
•To be included in seasonal and perennial allergic rhinitis group
•To have a related complaint for at least 2 years
•To be informed about the study and to give consent to participate in the study

Exclusion Criteria

•Diagnosis of superficial nasal mucosal erosion, moderate nasal mucosal erosion, nasal mucosal ulceration and nasal septum perforation during nasal examination
•Presence of nasal diseases that are likely to affect the accumulation of intranasal drugs, such as acute or chronic sinusitis, rhinitis medicamentosa, clinically significant polyposis or clinically significant nasal structural abnormalities
•Having undergone a nasal or sinus surgery for up to one year before the study
•The use of systemic or topical steroids within the last 15 days prior to inclusion in the study
•The use of antihistamine, chromoline Na within the last 15 days prior to inclusion in the study
•The use of any investigational drug within 30 days prior to Visit 1;
•Known hypersensitivity to components of the products used in the study
•Presence of respiratory infections, which have developed within the two weeks prior to Visit 1
•Diagnosis of COPD
•A history of alcohol or drug addiction treatment within the last 2 years prior to inclusion in the study, or any current addiction on alcohol or drugs,