Efficacy and Safety Study of AI201901 in Allergic Rhinitis Patients

Study Overview
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Brief Summary
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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.

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

Conditions
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Allergic Rhinitis Due to Allergens

Intervention / Treatment
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* Drug: AI201901
* Drug: Azelastine Hydrochloride


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The first group will receive AI201901 , whereas the second group will receive azelastine hydrochloride. Patients that will receive AI201901 are defined as the test arm and patients that will receive azelastine hydrochloride are defined as the active control arm.
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Allergic Rhinitis