Health Condition 1: J302- Other seasonal allergic rhinitis
Conditions
Interventions
Intervention1: RB-2410113, mometasone furoate Metered dose nasal spray, 2 doses per nostril once daily: Duration 14 days
Control Intervention1: Nasonex (mometasone furoate) Metered dose nasal spray,
Sponsors
PSK Pharma LLC
Mudra Clincare
Eligibility
Inclusion criteria
Inclusion criteria: 1.Availability of written informed consent (IC) for participation in the trial in accordance with current legislation, obtained prior to the commencement of any trial procedures 2.Patients of both sexes aged 18 to 65 years at the time of signing the IC (inclusive) with moderate or severe SAR recorded at the time of screening. Moderate severity is defined as rhinitis symptoms that interfere with work, study, sports and disrupt the patient sleep. High severity degree is defined as rhinitis symptoms that significantly worsen the patients quality of life, who, in the absence of therapy, cannot work, study, or play sports normally; night sleep is significantly disrupted 3.Documented clinical history of SAR for at least 2 years prior to screening 4. Documented positive results of skin tests (prick test or scarification test) and/or elevated levels of specific IgE antibodies in the blood serum to at least one pollen allergen characteristic of the pollen season during which the clinical trial is conducted, obtained within 12 months prior to screening 5.Patients ability to adhere to the protocol, including keeping a daily symptoms diary. 6. Patients of both sexes who may have children must agree to use effective contraception throughout the trial and for 30 days after the last dose of the trial product. Effective methods of contraception include a double barrier method or a single barrier method combined with an intrauterine device or oral contraceptives 7. Negative urine pregnancy test for female patients of childbearing potential. The exceptions are females who have had no menstruation for 2 years or more or who are surgically sterile (for example, after hysterectomy, bilateral oophorectomy, tubal ligation) 8. Total rTNSS score greater than or equal to 6 in the previous 24 hours, including at least 2 points for the nasal congestion symptom and at least 2 points for one of the other three symptoms (rhinorrhea, nasal itching, or sneezing) at screening.
Exclusion criteria
Exclusion criteria: 1. Presence of persistent symptoms of perennial rhinitis (except in cases where the Investigator assesses the patients symptoms as a manifestation of SAR) 2. Patients with symptoms of perennial rhinitis only or with symptoms of SAR, if the patient has previously shown positive results of a skin allergy test with an allergen that is not typical for the blossom season during which the clinical trial is being conducted 3. Active tuberculosis or history of tuberculosis 4. Any other fungal, bacterial or systemic viral infections in the absence of adequate therapy in the opinion of the Investigator within 30 days prior to screening 5. Acute upper respiratory tract infections (ARVI, pharyngitis, tonsillitis) at the time of screening or within 30 days before it
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in mean reflective total nasal symptom score (rTNSS)Timepoint: Visit 4 (Day 14) | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in rTNSS and iTNSS (total and individual symptoms)Timepoint: Visit 3 (Day 7), Visit 4 (Day 14);50 percent reduction in total rTNSSTimepoint: Visit 3 (Day 7), Visit 4 (Day 14);Treatment adherenceTimepoint: Visit 3 (Day 7), Visit 4 (Day 14);Safety (AEs/SAEs)Timepoint: Throughout trial | — |
Countries
India, Russian Federation
Contacts
Public ContactDr Sayali Sadgune
Mudra Clincare
Outcome results
None listed