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

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)

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Key information

Conditions

Seasonal Allergic Rhinitis (SAR) Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Nose Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Respiratory Tract Diseases Rhinitis Rhinitis, Allergic Rhinitis, Allergic, Seasonal

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Investigational Site 406, Mission Viejo, California, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

GSP 301 NS

Drug

2 spray in each nostril twice daily for 14 days

GOM-NS

Drug

2 spray in each nostril twice daily for 14 days

GMM-2 NS

Drug

2 spray in each nostril twice daily for 14 days

GSP 301 Placebo NS

Drug

2 spray in each nostril twice daily for 14 days

Primary outcomes

Change From Baseline in Average AM and PM Subject-reported 12-hour Reflective Total Nasal Symptom Score (rTNSS)

Time frame: 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).

Sponsors and collaborators

Lead sponsor

Glenmark Specialty S.A.

Industry

Registry information

Official study title

A Double-Blind, Randomized, Parallel-Group Seasonal Allergic Rhinitis (SAR) Study to Evaluate the Efficacy, Safety and Tolerability of GSP 301 Nasal Spray Compared With Placebo Nasal Spray and Individual Monotherapy Formulations (Olopatadine Hydrochloride Nasal Spray and Mometasone Furoate Nasal Spray) in Adult and Adolescent Subjects (12 Years of Age and Older)

Acronym: GSP 301-304

Important dates

Study start: 2016
Primary completion: 2017
Study completion: 2017
First posted: Aug 17, 2016
Registry last updated: Apr 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed