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Efficacy and Safety Study of AI201901 in Allergic Rhinitis Patients

NCT04729517 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 210

Last updated 2023-09-08

No results posted yet for this study

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.

Conditions

  • Allergic Rhinitis Due to Allergens

Interventions

DRUG

AI201901

Twice daily inhaled AI201901 for 4 weeks

DRUG

Azelastine Hydrochloride

Twice daily inhaled Azelastine Hydrochloride for 4 weeks

Sponsors & Collaborators

  • Istanbul Umraniye Training and Research Hospital

    collaborator UNKNOWN

  • Diskapi Yildirim Beyazit Education and Research Hospital

    collaborator OTHER_GOV

  • Antalya Training and Research Hospital

    collaborator OTHER_GOV

  • Dokuz Eylul University

    collaborator OTHER

  • Ankara City Hospital Bilkent

    collaborator OTHER

  • Kahramanmaras Sutcu Imam University

    collaborator OTHER

  • Uludag University

    collaborator OTHER

  • Karadeniz Technical University

    collaborator OTHER

  • Kartal Dr. Lütfi Kirdar City Hospital

    collaborator UNKNOWN

  • Abdi Ibrahim Ilac San. ve Tic A.S.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-20
Primary Completion
2023-03-03
Completion
2023-05-02

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04729517 on ClinicalTrials.gov