Efficacy and Safety Study of AI201901 in Allergic Rhinitis Patients (HILARIA)

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

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.

Study Overview

• Status: Completed
• Conditions: Allergic Rhinitis Due to Allergens
• Intervention / Treatment: Drug: Azelastine Hydrochloride; Drug: AI201901

• Study Type: Interventional
• Enrollment (Actual): 210
• Phase: Phase 3

Contacts and Locations

Study Locations

• Turkey
  • Izmir, Turkey
    • Dokuz Eylul University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Azelastine Hydrochloride; Patients that will receive azelastine hydrochloride are defined as the active control arm.	Drug: Azelastine Hydrochloride; Twice daily inhaled Azelastine Hydrochloride for 4 weeks; Other Names: Allergodil
Experimental: AI201901; Patients that will receive AI201901 are defined as the test arm.	Drug: AI201901; Twice daily inhaled AI201901 for 4 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Nasal Symptom Score	Achieve a statistically significant improvement in the symptoms of allergic rhinitis via Total Nasal Symptom Score (TNSS).	28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
TNNSS; Total non nasal symptom score	In non-nasal symptom scores (TNNSS), AI201901 is similar compared to azelastine	28 days
The rhinoconjunctivitis quality of life scale (RQLQ)	The rhinoconjunctivitis quality of life scale (RQLQ) indicates that AI201901 is similar compared to azelastine	28 days
Odor Visual Analogue Score (VAS)	In Odor Visual Analogue Score (VAS) results, AI201901 is better than azelastine	28 days
Inspiratory peak flow meter (PNIF)	Inspiratory peak flow meter (PNIF) results show that AI201901 is similar compared to azelastine	28 days
Connecticut butanol odor threshold test	Connecticut butanol odor threshold tests show that AI201901 is similar compared to azelastine	28 days
Rhinoscopic Assessment Scale	Results of the Rhinoscopic Assessment Scale show that AI201901 is better than azelastine	28 days
Safety of AI201901	Demonstration of the safety of AI201901 by comparing the number of participants with treatment-related adverse events in each arm.	28 days

Collaborators and Investigators

• Sponsor: Abdi Ibrahim Ilac San. ve Tic A.S.
• Collaborators: Dokuz Eylul University; Kahramanmaras Sutcu Imam University; Antalya Training and Research Hospital; Ankara City Hospital Bilkent; Uludag University; Karadeniz Technical University; Diskapi Yildirim Beyazit Education and Research Hospital; Istanbul Umraniye Training and Research Hospital; Kartal Dr. Lütfi Kirdar City Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2021
• Primary Completion (Actual): March 3, 2023
• Study Completion (Actual): May 2, 2023

Study Registration Dates

• First Submitted: January 20, 2021
• First Submitted That Met QC Criteria: January 27, 2021
• First Posted (Actual): January 28, 2021

Study Record Updates

• Last Update Posted (Actual): September 8, 2023
• Last Update Submitted That Met QC Criteria: September 6, 2023
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Allergic Rhinitis
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Rhinitis; Rhinitis, Allergic; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Anti-Allergic Agents; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents; Histamine H1 Antagonists, Non-Sedating; Lipoxygenase Inhibitors; Azelastine
• Other Study ID Numbers: Aİ-2019-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No