Efficacy and Safety of GSP 301 Nasal Spray in the Treatment of Seasonal Allergic Rhinitis (SAR)

Phase 3

Completed

• Conditions: Seasonal Allergic Rhinitis (SAR)
• Interventions: Drug: GSP 301 placebo NS; Drug: GOM-NS; Drug: GSP 301 NS; Drug: GMM-2 NS

• Registration Number: NCT02870205
• Lead Sponsor: Glenmark Specialty S.A.

Brief Summary

Study to evaluate the efficacy, safety and tolerability of GSP 301 NS compared with placebo NS and individual monotherapy formulations for the treatment of Seasonal Allergic Rhinitis (subjects 12 years of age and older)

Detailed Description

Not available

Study Timeline

• Study Start: 2016-08
• Study First Submitted: 2016-08-12
• Study First Submitted QC: 2016-08-12
• Study First Posted: 2016-08-17
• Primary Completion: 2017-01
• Study Completion: 2017-01
• Results First Submitted: 2018-01-31
• Status Verified: 2018-04
• Results First Submitted QC: 2018-04-05
• Last Update Submitted: 2018-04-05
• Results First Posted: 2018-04-06
• Last Update Posted: 2018-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1176

Inclusion Criteria

• Males and non-pregnant females who are 12 years of age and older.
• Documented clinical history of SAR (for at least 2 years preceding the Screening Visit [Visit 1]) with exacerbations (clinical evidence of active symptoms) for the relevant seasonal allergen during the Fall or mountain cedar allergy seasons (e.g., ragweed or mountain cedar pollen)
• A 12-hour rTNSS ≥8 out of a possible 12 and a congestion score ≥2 for the AM assessment at the Screening Visit (Visit 1).

Exclusion Criteria

• Pregnant or lactating women.
• History of anaphylaxis and/or other severe local reaction(s) to skin testing.
• History of positive test for HIV, Hepatitis B or Hepatitis C infection.
• Documented evidence of acute or significant chronic sinusitis or chronic purulent postnasal drip.
• Subjects with an active pulmonary disorder or infection.
• Subjects with posterior subcapsular cataracts or glaucoma
• Plans to travel outside the known pollen area for the investigational site for 24 hours or longer during the last 7 days of the run-in period.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GSP 301 placebo NS	GSP 301 placebo NS	-
GOM-NS	GOM-NS	-
GSP 301 NS	GSP 301 NS	-
GMM-2 NS	GMM-2 NS	-

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Average AM and PM Subject-reported 12-hour Reflective Total Nasal Symptom Score (rTNSS)	Baseline and day 14	The Reflective Total Nasal Symptom Score (rTNSS) was assessed by 12-hour reflective scoring of the severity of four nasal symptoms (rhinorrhea, sneezing, nasal congestion, nasal itching). Symptom scores ranged from 0 (no signs/symptoms evident) to 3 (severe signs/symptoms that is hard to tolerate). The rTNSS was calculated as the sum of the subject-reported severity scores for nasal symptoms, and value ranged from 0 (no signs/symptoms evident) to 12 (severe signs/symptoms that is hard to tolerate).

Trial Locations

Locations (43)

Investigational Site 406; 🇺🇸 Mission Viejo, California, United States

Investigational Site 414; 🇺🇸 Orange, California, United States

Investigational Site 435; 🇺🇸 San Diego, California, United States

Investigational Site 420; 🇺🇸 Centennial, Colorado, United States

Investigational Site 444; 🇺🇸 Colorado Springs, Colorado, United States

Investigational Site 428; 🇺🇸 Aventura, Florida, United States

Investigational Site 412; 🇺🇸 Miami, Florida, United States

Investigational Site 436; 🇺🇸 Bethesda, Maryland, United States

Investigational Site 432; 🇺🇸 South Dartmouth, Massachusetts, United States

Investigational Site 426; 🇺🇸 Minneapolis, Minnesota, United States

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