Clinical trial NCT04729517: Efficacy and Safety Study of AI201901 in Allergic Rhinitis Patients
Official title: Randomized Multicenter Phase III Efficacy and Safety Study of AI201901 in Allergic Rhinitis Patients (HILARIA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Allergic Rhinitis Due to Allergens
Keywords: Allergic Rhinitis
Lead sponsor: Abdi Ibrahim Ilac San. ve Tic A.S.
Sponsor class: INDUSTRY
Collaborators: name: Istanbul Umraniye Training and Research Hospital
name: Diskapi Yildirim Beyazit Education and Research Hospital
name: Antalya Training and Research Hospital
name: Dokuz Eylul University
name: Ankara City Hospital Bilkent
name: Kahramanmaras Sutcu Imam University
name: Uludag University
name: Karadeniz Technical University
name: Kartal Dr. Lütfi Kirdar City Hospital
First posted: 2021-01-28
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Total Nasal Symptom Score
timeFrame: 28 days
Secondary outcomes:
measure: TNNSS; Total non nasal symptom score
timeFrame: 28 days
measure: The rhinoconjunctivitis quality of life scale (RQLQ)
timeFrame: 28 days
measure: Odor Visual Analogue Score (VAS)
timeFrame: 28 days
measure: Inspiratory peak flow meter (PNIF)
timeFrame: 28 days
measure: Connecticut butanol odor threshold test
timeFrame: 28 days
measure: Rhinoscopic Assessment Scale
timeFrame: 28 days
measure: Safety of AI201901
timeFrame: 28 days
Other outcomes:
Locations:
city: Izmir
country: Turkey
facility: Dokuz Eylul University
Study officials:
References: