Efficacy and Safety of Fixed Dose Combination (FDC) of Olopatadine Hydrochloride and Mometasone Furoate Nasal Spray (Molo; Also Referred as GSP 301) in the Treatment of Seasonal Allergic Rhinitis (SAR) (GSP 301- PoC)
Seasonal Allergic Rhinitis
About this trial
This is an interventional treatment trial for Seasonal Allergic Rhinitis focused on measuring SAR
Eligibility Criteria
Inclusion Criteria:
- Male and female patients aged 18 to 65 years (inclusive) with a clinical history of seasonal allergic rhinitis (SAR) (for at least 2 years) and exhibiting a positive skin prick test
Exclusion Criteria:
- Pregnant or lactating women
- Patients with known hypersensitivity to any of the components of the formulation
- Patients with a history of seasonal asthma during ragweed season.
- Patient requiring chronic use of inhaled or systemic corticosteroids
- Patients with perennial rhinitis; non-allergic rhinitis; or ocular infection within 3 weeks before the screening
- Patients with history of acute or significant chronic sinusitis or chronic purulent post-nasal drip or Rhinitis Medicamentosa as determined by the Investigator.
- Patients with history of narrow-angle glaucoma, increased intraocular pressure, posterior subcapsular cataract, urinary retention, uncontrolled hypertension, severe Coronary Artery Disease, Ischemic Heart Disease, uncontrolled Diabetes Mellitus, Hyperthyroidism, Renal Impairment or Prostatic Hypertrophy, and those receiving MAO inhibitor therapy.
Sites / Locations
- Glenmark Investigational Site 1
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Placebo Comparator
Experimental
Experimental
Active Comparator
Active Comparator
Placebo nasal spray
Molo 1 (also referred as GSP 301-2 NS)
Molo 2 (also referred as GSP 301-1 NS)
DYMISTA nasal spray
PATANASE nasal spray
Placebo nasal spray - 2 sprays per nostril, BID
Fixed Dose Combination of Molo nasal spray (olopatadine hydrochloride 665 mcg and mometasone furoate 25 mcg nasal spray) - 2 sprays per nostril, BID
Fixed Dose Combination of Molo nasal spray (olopatadine hydrochloride 665 mcg and mometasone furoate 50 mcg nasal spray) - 2 sprays per nostril, QD
Fixed Dose Combination of azelastine hydrochloride 137 mcg and fluticasone propionate 50 mcg nasal spray - 1 spray per nostril, BID
Olopatadine hydrochloride 665 mcg nasal spray - 2 sprays per nostril, BID