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

Abdi Ibrahim Pharmaceuticals

Status and phase

Completed

Phase 3

Conditions

Allergic Rhinitis Due to Allergens

Treatments

Drug: AI201901

Drug: Azelastine Hydrochloride

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT04729517

Aİ-2019-01

Details and patient eligibility

About

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.

Enrollment

210 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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