Seasonal Allergic Rhinitis Clinical Trial
Official title:
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.
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).
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. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT01337323 -
Prospective Observational Study of Concomitant Allergic Rhinitis Treatment Patterns Among Patients Starting on Fluticasone Furoate Nasal Spray in a Retail Pharmacy Setting
|
N/A | |
Completed |
NCT01171664 -
Clinical Trial of STAHIST in Seasonal Allergic Rhinitis (SAR) Subjects
|
Phase 2 | |
Completed |
NCT00784732 -
A Study to Compare the Efficacy of QAV680 Against Placebo in Treating Seasonal Allergic Rhinitis in an Environmental Exposure Chamber
|
Phase 2 | |
Completed |
NCT00578929 -
Safety and Efficacy of Olopatadine HCl Nasal Spray in 6-11 Year Old Patients
|
Phase 3 | |
Completed |
NCT00619827 -
Efficacy and Safety of Sublingual Tablets of Grass Pollen Allergen Extract
|
Phase 1 | |
Completed |
NCT00209365 -
The Role of Pollen Starch Granules in Pollen Challenge Studies in the Fraunhofer Environmental Exposure Unit
|
N/A | |
Terminated |
NCT00223587 -
Seasonal Allergic Rhinitis and Driving Ability
|
Phase 4 | |
Completed |
NCT00637455 -
Single Center, Randomized, Double-Blind,Crossover Study Comparing Effects Of Single-Dose Fexofenadine HCl 180 mg, Cetirizine 10 mg, and Placebo on Cognitive Performance in Naval Flight Personnel
|
Phase 4 | |
Completed |
NCT00963599 -
Montelukast in Seasonal Allergic Rhinitis - Fall 1999 Study (0476A-117)
|
Phase 3 | |
Recruiting |
NCT05346718 -
Threshold Concentrations for Ragweed and Birch Pollen in Seasonal Allergic Rhinitis
|
N/A | |
Completed |
NCT06126952 -
Azelastine Allergen Chamber - Onset of Action Study
|
Phase 2 | |
Completed |
NCT02245360 -
Study Immunology and Safety of 60-day Treatment of SQ Grass SLIT (Sublingual Immunotherapy)-Tablet in Adult Subjects With Grass Pollen-induced Allergic Rhinoconjunctivitis
|
Phase 3 | |
Completed |
NCT01940146 -
Efficacy and Safety of SPARC1310 in Seasonal Allergic Rhinitis
|
Phase 2 | |
Completed |
NCT01230619 -
Vienna Challenge Chamber Study Using RV658 in Subjects With Allergic Rhinitis
|
Phase 2 | |
Completed |
NCT00561717 -
A Randomized, Placebo Controlled Study to Determine the Efficacy and Speed of a Nasal Spray in Allergen Induced Seasonal Allergic Rhinitis
|
Phase 4 | |
Completed |
NCT00574210 -
PK/PD and Steady State Efficacy Study of Bilastine Compared With Placebo Given Orally in the Treatment of the Symptoms of SAR in an EEC Model (5-arm)
|
Phase 2 | |
Completed |
NCT00405899 -
Pilot Study of Allergy Immunotherapy and Prevention of Viral Respiratory Infections
|
N/A | |
Completed |
NCT00443495 -
Phase I/IIa Study on Chitin Microparticles in Subjects Suffering From Allergic Rhinitis
|
Phase 1/Phase 2 | |
Completed |
NCT00420082 -
A Randomized, Double-Blind, 4-way Crossover Study to Evaluate the Efficacy of Bilastine in the Vienna Challenge Chamber
|
Phase 2 | |
Completed |
NCT03097432 -
Non-interventional Study to Assess the Tolerability, the Safety Profile and the Adherence of Different Up-dosing Schemes for a Sublingual Immunotherapy Treatment
|
N/A |