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)

Seasonal Allergic Rhinitis Clinical Trial

— GSP 301- PoC  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03444506
• Other study ID #: GPL/CT/2013/001/II
• Status: Completed
• Phase: Phase 2
• Start date: January 27, 2014
• Est. completion date: February 28, 2014

Study information

• Verified date: June 2018
• Source: Glenmark Pharmaceuticals Ltd. India
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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®.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: February 28, 2014
• Est. primary completion date: February 28, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Rhinitis
• Rhinitis, Allergic
• Rhinitis, Allergic, Seasonal
• Seasonal Allergic Rhinitis

Intervention

Drug:
• Molo 1 (also referred as GSP 301-2 NS)

• Molo 2 (also referred as GSP 301-1 NS)

• Placebo nasal spray

• DYMISTA nasal spray

• PATANASE nasal spray

Locations

Country	Name	City	State
Canada	Glenmark Investigational Site 1	Mississauga	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Glenmark Pharmaceuticals Ltd. India

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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).	15 days
Secondary	Change in mean post-treatment iTNSS for Molo 1 and Molo 2 compared with reference products Dymista and Patanase	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).	15 days
Secondary	Change in mean post-treatment iTNSS for reference products Dymista and Patanase compared with placebo	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).	15 days
Secondary	Onset of action assessed by comparing change in iTNSS after the first dose		15 days
Secondary	Change from baseline in post-treatment instantaneous Total Symptoms Score (iTSS) (Molo 1 and Molo 2 versus Active Comparator)	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).	15 days
Secondary	Change from baseline in individual instantaneous Nasal Symptoms Scores (iNSS) (Molo 1 and Molo 2 versus Active Comparator)	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).	15 days
Secondary	Change from baseline in instantaneous Total Ocular Symptom Score (iTOSS) (Molo 1 and Molo 2 versus Active Comparator)	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).	15 days
Secondary	Change in mean post-treatment Environmental Exposure Chamber - Rhinoconjunctivitis Quality-of-Life Questionnaire (EEC-QoLQ) scores	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).	15 days
Secondary	Responses to a reflective Global Assessment of Tolerability and Acceptance Questionnaire (GATAQ)	Scale of 0 (very much acceptable) - 6 (not acceptable)	15 days