Efficacy and Safety Study of AI201901 in Allergic Rhinitis Patients

NCT ID: NCT04729517

Last Updated: 2023-09-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 210 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-20
• Study Completion Date: 2023-05-02

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.

Conditions

Allergic Rhinitis Due to Allergens

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Azelastine Hydrochloride

Patients that will receive azelastine hydrochloride are defined as the active control arm.

Group Type: ACTIVE_COMPARATOR

Azelastine Hydrochloride

Intervention Type: DRUG

Twice daily inhaled Azelastine Hydrochloride for 4 weeks

AI201901

Patients that will receive AI201901 are defined as the test arm.

Group Type: EXPERIMENTAL

AI201901

Intervention Type: DRUG

Twice daily inhaled AI201901 for 4 weeks

Interventions

AI201901

Twice daily inhaled AI201901 for 4 weeks

Intervention Type: DRUG

Azelastine Hydrochloride

Twice daily inhaled Azelastine Hydrochloride for 4 weeks

Intervention Type: DRUG

Other Intervention Names

Allergodil

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,
• Use of alcohol and other drugs (antidepressants) that have a negative effect on reaction time / concurrent use of sedative drugs or other drugs that act on the central nervous system
• Presence of significant lung diseases including asthma. ((Only patients with intermittent asthma who need short-acting inhaled bronchodilators (no more than twice a week) and do not wake up at night due to asthma are suitable for inclusion)).
• Presence of chronic obstructive sleep-apnea syndrome (clinical diagnosis)
• Presence of any surgical or medical condition, which, according to the opinion of the responsible researcher, could significantly alter the absorption, distribution, metabolism, or excretion of the investigational product, or could significantly affect the patient's ability to complete this study
• Presence of symptoms in the medical history in relation to glaucoma, cataract, ocular herpes simplex, conjunctivitis, or other ocular infections
• Presence of medical history in relation to active or latent tuberculosis
• Presence or risk of exposure to chickenpox or measles within the last 30 days
• Presence of untreated fungi, bacteria or systemic viral infection within the last 30 days
• Being pregnant or breastfeeding
• Women of reproductive age who do not use a medically valid contraceptive method
• Presence of cystic fibrosis
• Presence of primary ciliary dyskinesia
• Use of intranasal or systemic first-generation antihistamines, leukotriene receptor antagonists or other nasal decongestants during the study
• Use of any ophthalmic steroid or nasal, inhaled or systemic steroid during the study
• Use of another clinical research product during the study

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istanbul Umraniye Training and Research Hospital

UNKNOWN

Sponsor Role: collaborator

Diskapi Yildirim Beyazit Education and Research Hospital

OTHER_GOV

Sponsor Role: collaborator

Antalya Training and Research Hospital

OTHER_GOV

Sponsor Role: collaborator

Dokuz Eylul University

OTHER

Sponsor Role: collaborator

Ankara City Hospital Bilkent

OTHER

Sponsor Role: collaborator

Kahramanmaras Sutcu Imam University

OTHER

Sponsor Role: collaborator

Uludag University

OTHER

Sponsor Role: collaborator

Karadeniz Technical University

OTHER

Sponsor Role: collaborator

Kartal Dr. Lütfi Kirdar City Hospital

UNKNOWN

Sponsor Role: collaborator

Abdi Ibrahim Ilac San. ve Tic A.S.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Dokuz Eylul University

Izmir, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

Aİ-2019-01

Identifier Type: -

Identifier Source: org_study_id