Phase
Condition
Nasal Obstruction
Rhinitis, Allergic, Perennial
Allergy
Treatment
Momat Rhino Advance
Azelastine + Mometazone, nasal spray
Clinical Study ID
Ages 18-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria: Patients meeting the following criteria will be included in the study and allocated totreatment groups:
- 18 to 65 years old inclusive, male and female;
- voluntarily signed informed consent for participation in this clinical study;
- presence of confirmed moderate or severe seasonal allergic rhinitis occurring duringpollen/allergen season of at least 24 months prior to enrollment in the study;
- presence of nasal symptoms of SAR (nasal congestion, rhinorrhea, nasal itching,sneezing): total score as per scale of reflective Total Nasal Symptoms Score (r-TNSS)at least 6: wherein, nasal congestion - at least 2 scores, as well as at least 2scores in assessment of at least one of other three symptoms at Screening Visit andVisit 2;
- presence of documented positive result for dermic allergy test and/or serologyallergen-specific IgE test performed for one or more allergens 12 months or earlierprior to enrollment to this study (patients should have positive skin tests and/orserology allergen-specific IgE test at least with one allergen, specific to the seasonduring which clinical trial is conducted);
- fertile females shall have negative pregnancy test at screening (except for the womenafter surgical sterilization or with 2 year and more period of menopause);
- for women of child-bearing potential - consent to use one of following methods ofeffective contraception for the duration of study, as well for 30 days after the studyend: Total abstinence. Oral contraceptives (combination medications containingprogestagen or only progestagen). Injection progestogen. Implants with levonorgestrel. Estrogen containing vaginal ring. Skinpatch with contraceptive. Intrauterine device (IUD) or intrauterine system (IUS) thatcomplies with efficacy criteria as stated in PIL.
- Male partner is sterile (vasectomy with documented azoospermia) prior to femaleenrollment into the study based on condition that this partner is the only partner forthis patient. For this definition "documented" is related to the result of medicalexamination by Investigator/Patient's Responsible Party or medical history review forassessment of enrollment to the study received orally by the patient or from medicalrecord of the patient.
- Double barrier method: condom or occlusive cap (diaphragm or cervical/camerated cap)plus spermicide (foam/gel/film/cream/suppository);
- for male subjects: consent to follow with the female partner adequate contraceptionmethod for the duration of participation in the study from beginning to the end, aswell as for 30 days after the end of the study;
- absence of somatic diseases of unstable severe character or in the phase ofdecompensation;
- ability to understand information about clinical study, readiness to followrequirements of study protocol, ability to use dosed nasal spray individually andassess symptoms of seasonal allergic rhinitis with the help of rating scale. Non-inclusion Criteria: Patients related to any of the following groups will not be included in the study:
- Patients with hypersensitivity to mometasone/ azelastine and/or excipients containingin test product/reference product.
- Patients with anaphylaxis and/or other severe local reaction(s) to skin testdocumented in medical history (scarification tests/prick tests).
- Negative or controversial result of dermic allergy tests and/or serologyallergen-specific IgE test.
- Patients with asthma in medical history with regard to which during last 2 yearsregular therapy was required; patients with light asthma connected with physicalexercises are enrolled to the study based on condition that it is treated only withbeta-adrenergic agonists of short action.
- Patients with nasal cavity and/or paranasal sinuses diseases, including: acute or chronic sinusitis; non-allergic rhinitis, fungal and bacterial infection, as wellas with purulent discharge from nose for 30 days, virus infections for 7 days prior toadministration of compared products; perennial allergic rhinitis; rhinitis medicamentosa;atrophic rhinitis; nasal polyps with breathing difficulty; erosion and ulcer of nasalmucosa; significant deflection of nasal septum, other structural changes in nasal cavitythat preclude from correct air transit; nasal bleeding tendency.
- Patients who resumed immune therapy (including locally administered products); orpatients who had changes in the schedule of allergen-specific immune therapy in theperiod of 30 days prior to Screening visit or patients who have planned to startimmune therapy during participation in the study.
- Patients who had surgery of nasal cavity or paranasal sinuses, nasal trauma, ocularsurgery or eye trauma less than 12 months (1 year) prior to Screening visit
- Treatment of oral cavity candidiasis 30 days prior to Screening visit or patients withoral cavity candidiasis at the moment of Screening visit.
- Patients with past or unstable concomitant diseases or clinical states that precludepatient from enrollment to the study (decision is taken by investigator), including: respiratory diseases (for example, pulmonary tuberculosis, severe asthma, airwayhyperreactivity, other broncho-obstructive diseases); untreated fungal, bacterial, virusinfections (including herpes simplex); dysfunction of hypothalamo-pituitary-adrenal axis;diabetes; arterial hypertension; oncology diseases; mental illnesses, administration ofmonoaminooxidase inhibitors (IMAO), tricyclic antidepressants; angle-closure glaucoma,increased intraocular pressure, posterior subcapsular cataract; eye Herpes simplex or othereye infections in the period of 14 days prior to Screening visit; Hepatitis B or C,syphilis; HIV infected patients;
- Varicella or rubeola or contacts with patients diagnosed with varicella or rubeola inthe period of 30 days prior to Screening visit.
- Administration of any glucocorticosteroid ophthalmologic products in the period of 14days or nasally inhaled, systematic glucocorticosteroids in the period of 30 daysprior to Screening visit. Hormonal contraception or hormonal replacement therapy isacceptable in case that patient has stable dosing regimen for at least 30 days priorto Screening visit or has stable dosing regimen for the period of the study.
- Administration of nasal or other systemic first generation antihistamines,antileukotrienes or other decongestants in the period of 3 days prior to Screeningvisit.
- Administration of nasal or systemiс second generation antihistamines in the period of 10 days prior to Screening visit.
- Administration of medicinal products containing cromoglicic acid in the period of 14days prior to Screening visit.
- Administration of any tricyclic antidepressants in the period of 30 days prior toScreening visit.
- Patients with attention deficit disorder without stable therapy regime in the periodof 30 days prior to Screening visit or planning to change therapy regime in the periodof study.
- ASIT (allergen-specific immunotherapy) by seasonal allergen which was the cause ofallergic rhinitis for the patient in the period of 6 months prior to Screening visit.
- Seasonal allergic rhinitis or perennial allergic rhinitis not responding toglucocorticosteroids documented in medical history;
- Patients that are not willing to refrain from any systemic or local (i.ae. nasal,ophthalmologic) vasoconstrictive, decongestant products and/or other products fortreatment of SAR from the moment of informed consent signed and prior to Follow-upvisit;
- Patients with history or presence of drug/alcohol abuse.
- Pregnant or breast-feeding females.
- Male patients and female patients with reproductive potential that refuse to useadequate contraception methods during the study and for 30 days after lastadministration of compared products.
- Patients who had surgery in the period of 30 days prior to Screening visit andpatients that will have surgeries during the study (prior to the end of Follow-upvisit), as well as diagnostic procedures or visiting in-patient clinic.
- Patients participating in other clinical studies of medicinal products at the momentof Screening visit or that participated in them in the period of 30 days prior toScreening visit.
- Possibility of traveling outside the region of permanent residence during the studyconduct.
- Any diseases or circumstances which, in Investigator's opinion, can prevent subjectfrom participation in the study or which can present danger to the subject'sparticipation in the study.
- Positive tests for markers of viral hepatitis B, C, syphilis, HIV infection, PCR testfor coronavirus SARS-CoV-2.
- Positive breath alcohol vapor test.
- Positive urine test for narcotic drugs and psychotropic substances (cocaine, cannabis,amphetamine, barbiturates, benzodiazepines and opioids).
Exclusion
Exclusion Criteria: The subject's participation will be terminated if any of the following causes occurs:
- The occurrence of any disease or condition during the study that worsens the patient'sprognosis and makes it impossible for the patient to participate further in theclinical trial.
- The need to prescribe prohibited concomitant therapy.
- A positive PCR test for SARS-CoV-2.
- Pregnancy of the patient.
- Violation of the Study Protocol: Erroneous inclusion of a patient who does not meetthe inclusion criteria and/or meets the non-inclusion criteria; taking forbiddentherapy; Other violations of the Protocol, which in the opinion of the Investigatorare significant.
- Patient's refusal to participate in the study.
- Other administrative reasons
Study Design
Study Description
Connect with a study center
Sandoz Investigative Site
Chelyabinsk, 454048
Russian FederationSite Not Available
Sandoz Investigative Site
Khasavyurt, 368006
Russian FederationSite Not Available
Sandoz Investigative Site
Krasnodar, 350012
Russian FederationSite Not Available
Sandoz Investigative Site
Nalchik, 360002
Russian FederationSite Not Available
Sandoz Investigative Site
Pyatigorsk, 357501
Russian FederationSite Not Available
Sandoz Investigative Site
Saint Petersburg, 196158
Russian FederationSite Not Available
Sandoz Investigative Site
Saint-Petersburg, 197342
Russian FederationSite Not Available
Sandoz Investigative Site
Saratov, 410054
Russian FederationSite Not Available
Sandoz Investigative Site
Stavropol, 355000
Russian FederationSite Not Available
Sandoz Investigative Site
Vladikavkaz, 362027
Russian FederationSite Not Available
Sandoz Investigative Site
Volgograd, 400005
Russian FederationSite Not Available
Sandoz Investigative Site
Yaroslavl, 150040
Russian FederationSite Not Available

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