Clinical trial NCT03444506: 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)
Official title: A Single-Center, Double-Blind, Double-Dummy, Randomized, Parallel-Group, Comparative Environmental Exposure Chamber (EEC) Study to Evaluate Efficacy, Safety and Tolerability of Two Fixed Dose Combination (FDC) Products of Olopatadine Hydrochloride and Mometasone Furoate Nasal Spray as Compared to the FDC of Azelastine Hydrochloride and Fluticasone Propionate Nasal Spray, Olopatadine Nasal Spray, and Placebo in Patients With Seasonal Allergic Rhinitis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Seasonal Allergic Rhinitis
Keywords: SAR
Lead sponsor: Glenmark Pharmaceuticals Ltd. India
Sponsor class: INDUSTRY
First posted: 2018-02-23
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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®.


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.

Primary outcomes:
measure: 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
timeFrame: 15 days
Secondary outcomes:
measure: Change in mean post-treatment iTNSS for Molo 1 and Molo 2 compared with reference products Dymista and Patanase
timeFrame: 15 days
measure: Change in mean post-treatment iTNSS for reference products Dymista and Patanase compared with placebo
timeFrame: 15 days
measure: Onset of action assessed by comparing change in iTNSS after the first dose
timeFrame: 15 days
measure: Change from baseline in post-treatment instantaneous Total Symptoms Score (iTSS) (Molo 1 and Molo 2 versus Active Comparator)
timeFrame: 15 days
measure: Change from baseline in individual instantaneous Nasal Symptoms Scores (iNSS) (Molo 1 and Molo 2 versus Active Comparator)
timeFrame: 15 days
measure: Change from baseline in instantaneous Total Ocular Symptom Score (iTOSS) (Molo 1 and Molo 2 versus Active Comparator)
timeFrame: 15 days
measure: Change in mean post-treatment Environmental Exposure Chamber - Rhinoconjunctivitis Quality-of-Life Questionnaire (EEC-QoLQ) scores
timeFrame: 15 days
measure: Responses to a reflective Global Assessment of Tolerability and Acceptance Questionnaire (GATAQ)
timeFrame: 15 days
Other outcomes:
Locations:
city: Mississauga
country: Canada
facility: Glenmark Investigational Site 1
state: Ontario
Study officials:
affiliation: Glenmark Pharmaceuticals
name: Sudeesh Tantry, PhD
role: STUDY_DIRECTOR
References:
citation: Patel P, Salapatek AM, Tantry SK. Effect of olopatadine-mometasone combination nasal spray on seasonal allergic rhinitis symptoms in an environmental exposure chamber study. Ann Allergy Asthma Immunol. 2019 Feb;122(2):160-166.e1. doi: 10.1016/j.anai.2018.10.011. Epub 2018 Oct 12.