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)
- Conditions
- Seasonal Allergic Rhinitis
- Interventions
- Drug: Placebo nasal sprayDrug: Molo 1 (also referred as GSP 301-2 NS)Drug: Molo 2 (also referred as GSP 301-1 NS)
- Registration Number
- NCT03444506
- Lead Sponsor
- Glenmark Pharmaceuticals Ltd. India
- Brief Summary
A single-center, double-blind, placebo-controlled study of FDC olopatadine hydrochloride and mometasone furoate nasal spray (Molo; also referred as GSP 301) was conducted in subjects with seasonal allergic rhinitis. In this study, the efficacy and safety of two regimens (BID and QD) of the FDC (i.e. Molo 1 and Molo 2) were evaluated compared to placebo nasal spray, DYMISTA® and PATANASE®.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 180
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo nasal spray Placebo nasal spray Placebo nasal spray - 2 sprays per nostril, BID Molo 1 (also referred as GSP 301-2 NS) Molo 1 (also referred as GSP 301-2 NS) Fixed Dose Combination of Molo nasal spray (olopatadine hydrochloride 665 mcg and mometasone furoate 25 mcg nasal spray) - 2 sprays per nostril, BID Molo 2 (also referred as GSP 301-1 NS) Molo 2 (also referred as GSP 301-1 NS) Fixed Dose Combination of Molo nasal spray (olopatadine hydrochloride 665 mcg and mometasone furoate 50 mcg nasal spray) - 2 sprays per nostril, QD DYMISTA nasal spray DYMISTA nasal spray Fixed Dose Combination of azelastine hydrochloride 137 mcg and fluticasone propionate 50 mcg nasal spray - 1 spray per nostril, BID PATANASE nasal spray PATANASE nasal spray Olopatadine hydrochloride 665 mcg nasal spray - 2 sprays per nostril, BID
- Primary Outcome Measures
Name Time Method Change in mean post-treatment instantaneous Total Nasal Symptoms Score (iTNSS) for Molo 1 and Molo 2 compared with placebo from baseline to end of treatment 15 days Instantaneous Total Nasal Symptom Score (iTNSS) is calculated as the sum of instantaneous scoring of the severity of four individual nasal symptoms (nasal congestion, rhinorrhea, nasal itching, sneezing). Subject responds on a 4-point severity scale with scores ranging from 0 (no signs/absent) to 3 (severe signs).
- Secondary Outcome Measures
Name Time Method Onset of action assessed by comparing change in iTNSS after the first dose 15 days Change from baseline in post-treatment instantaneous Total Symptoms Score (iTSS) (Molo 1 and Molo 2 versus Active Comparator) 15 days Instantaneous Total Symptom Score (iTSS) is calculated as the sum of the four individual nasal symptom (nasal congestion, rhinorrhea, nasal itching, sneezing) scores and the three individual ocular symptom (ocular itching, tearing/watering eyes, and ocular redness) scores. Subject responds on a 4-point severity scale with scores ranging from 0 (no signs/absent) to 3 (severe signs).
Responses to a reflective Global Assessment of Tolerability and Acceptance Questionnaire (GATAQ) 15 days Scale of 0 (very much acceptable) - 6 (not acceptable)
Change in mean post-treatment iTNSS for Molo 1 and Molo 2 compared with reference products Dymista and Patanase 15 days Instantaneous Total Nasal Symptom Score (iTNSS) is calculated as the sum of instantaneous scoring of the severity of four individual nasal symptoms (nasal congestion, rhinorrhea, nasal itching, sneezing). Subject responds on a 4-point severity scale with scores ranging from 0 (no signs/absent) to 3 (severe signs).
Change in mean post-treatment iTNSS for reference products Dymista and Patanase compared with placebo 15 days Instantaneous Total Nasal Symptom Score (iTNSS) is calculated as the sum of instantaneous scoring of the severity of four individual nasal symptoms (nasal congestion, rhinorrhea, nasal itching, sneezing). Subject responds on a 4-point severity scale with scores ranging from 0 (no signs/absent) to 3 (severe signs).
Change from baseline in individual instantaneous Nasal Symptoms Scores (iNSS) (Molo 1 and Molo 2 versus Active Comparator) 15 days Individual Instantaneous Nasal Symptoms Scores (iNSS) is calculated as the score of individual nasal symptoms (nasal congestion, rhinorrhea, nasal itching, sneezing). Subject responds on a 4-point severity scale with scores ranging from 0 (no signs/absent) to 3 (severe signs).
Change from baseline in instantaneous Total Ocular Symptom Score (iTOSS) (Molo 1 and Molo 2 versus Active Comparator) 15 days Instantaneous Total Ocular Symptom Score (iTOSS) is calculated as the sum of the three individual ocular symptoms (ocular itching, tearing/watering eyes, and ocular redness). Subject responds on a 4-point severity scale with scores ranging from 0 (no signs/absent) to 3 (severe signs).
Change in mean post-treatment Environmental Exposure Chamber - Rhinoconjunctivitis Quality-of-Life Questionnaire (EEC-QoLQ) scores 15 days The EEC-QoLQ has questions in three domains (non-nose/eye symptoms, practical problems and emotional) related to how much a subject was bothered with symptoms. Subject responds on a 7-point scale with score ranging from 0 (better outcome) to 6 (worse outcome).
Trial Locations
- Locations (1)
Glenmark Investigational Site 1
🇨🇦Mississauga, Ontario, Canada