Prospective, Multicenter, Open-label, Randomized, Parallel, Clinical Study for Assessment of Comparative Efficacy and Safety of Azelastine +Mometasone , Nasal Spray, 140 mcg + 50 mcg, (Sandoz d.d., Slovenia) and Momat Rino Advance, Nasal Spray, 140 mcg + 50 mcg, (Glenmark, India) Administered as a Monotherapy to Patients With Seasonal Allergic Rhinitis.
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Seasonal Allergic Rhinitis
- Sponsor
- Sandoz
- Enrollment
- 472
- Locations
- 1
- Primary Endpoint
- Mean total score change as per scale r-TNSS (AM/PM) with initial total score
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
Prospective, multicenter, open, randomized, parallel, clinical study for assessment of comparative efficacy and safety of Azelastine +Mometasone Sandoz (main group) and Momat Rino Advance (control group) administered as a monotherapy to patients with seasonal allergic rhinitis (SAR).
Detailed Description
The maximum observation period will be 22 days. Study periods * Screening (Visit 1): 1 day prior to Run-In period start (-4 day before study treatment ). * Run-In Period: 3 days prior to first administration of test product/reference product (-3 to -1 days before study treatment). * Randomization (Visit 2): assignment of test product/reference product to the patient (study treatment: day 1). * Administration of test product/reference product within Study days 1 to 14 and observation at Visits 2, 3, 4 which correspond to study days 1, 7, 15, respectively. * Period of follow-up (Visit 5): 36-96 h after last administration of test product/reference product. Performed in a form of a phone call (study treatment: days 16-18). Patients meeting the inclusion criteria and not meeting the non-inclusion criteria will be randomized into 2 groups in a 1:1 ratio. Dose of test product/reference product and dosing regimen used in this study are based on PIL of original product Momat Rino Advance approved by Ministry of Healthcare of the Russian Federation which is used in this study as a reference product. Test product and reference product in this study will be administered according to the following regimen: Group 1 (n=236) will receive test product Azelastine + Mometasone, nasal spray, 140 mcg + 50 mcg/dose (Sandoz d.d., Slovenia), one actuation in each nostril twice daily, morning and evening (recommended interval between administrations is approximately 12 hours), for 14 consecutive days. Group 2 (n=236) will receive reference product Momat Rhino Advance, nasal dosed spray, 140 mcg + 50 mcg mcg/dose (Glenmark Pharmaceuticals Limited., India), one actuation in each nostril twice daily, morning and evening (recommended interval between administrations is approximately 12 hours), for 14 consecutive days All study procedures for both groups at each phase of study are identical.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients meeting the following criteria will be included in the study and allocated to treatment 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 during pollen/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 2 scores in assessment of at least one of other three symptoms at Screening Visit and Visit 2;
- •presence of documented positive result for dermic allergy test and/or serology allergen-specific IgE test performed for one or more allergens 12 months or earlier prior to enrollment to this study (patients should have positive skin tests and/or serology allergen-specific IgE test at least with one allergen, specific to the season during which clinical trial is conducted);
- •fertile females shall have negative pregnancy test at screening (except for the women after surgical sterilization or with 2 year and more period of menopause);
- •for women of child-bearing potential - consent to use one of following methods of effective contraception for the duration of study, as well for 30 days after the study end: Total abstinence. Oral contraceptives (combination medications containing progestagen or only progestagen).
- •Injection progestogen. Implants with levonorgestrel. Estrogen containing vaginal ring. Skin patch with contraceptive. Intrauterine device (IUD) or intrauterine system (IUS) that complies with efficacy criteria as stated in PIL.
- •Male partner is sterile (vasectomy with documented azoospermia) prior to female enrollment into the study based on condition that this partner is the only partner for this patient. For this definition "documented" is related to the result of medical examination by Investigator/Patient's Responsible Party or medical history review for assessment of enrollment to the study received orally by the patient or from medical record of the patient.
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's prognosis and makes it impossible for the patient to participate further in the clinical trial.
- •The need to prescribe prohibited concomitant therapy.
- •A positive PCR test for SARS-CoV-
- •Pregnancy of the patient.
- •Violation of the Study Protocol: Erroneous inclusion of a patient who does not meet the inclusion criteria and/or meets the non-inclusion criteria; taking forbidden therapy; Other violations of the Protocol, which in the opinion of the Investigator are significant.
- •Patient's refusal to participate in the study.
- •Other administrative reasons
Outcomes
Primary Outcomes
Mean total score change as per scale r-TNSS (AM/PM) with initial total score
Time Frame: Day 1, 7 and 15 post treatment
r-TNSS (reflective Total Nasal Symptom Score) consists of 4 symptom scores (Nasal congestion, Runny nose, Itchy nose, Sneezing), each of which can be scored on a 4-point scale (0-3). Higher scores mean a more severe symptom. By its nature, the total index r-TNSS is a rank indicator, it is an integer from the range from 0 to 12 points. As a working indicator, the average between the morning and evening values is used. As a measure of the effect of the drug, the change in the index relative to the initial value is used. Baseline is defined as the average r-TNSS score over three days of the Run-in period (2 morning (AM) and 3 evening (PM)) plus morning measurements of study day 1 (assessment in the morning prior to first administration).
Secondary Outcomes
- Mean change in total score as per scales i-TNSS and r-TNSS with initial total score(Day 1, 7 and 15 post treatment)
- Number of Adverse events(throughout the study, approximately 18 days)
- Proportion of patients with at least one adverse event(throughout the study, approximately 18 days)
- Proportion of patients who discontinued treatment because of an adverse event(throughout the study, approximately 18 days)
- Mean total score change as per scale i-TNSS (AM/PM) with initial total score(Day 1, 7 and 15 post treatment)
- Change in Standardized Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ(S))(Day 1, 7 and 15 post treatment)