Efficacy and Safety of GSP 301 Nasal Spray in the Treatment of Seasonal Allergic Rhinitis (SAR)
GSP 301-304
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)
2 other identifiers
interventional
1,176
1 country
43
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Aug 2016
Shorter than P25 for phase_3
43 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2016
CompletedFirst Submitted
Initial submission to the registry
August 12, 2016
CompletedFirst Posted
Study publicly available on registry
August 17, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2017
CompletedResults Posted
Study results publicly available
April 6, 2018
CompletedApril 6, 2018
April 1, 2018
5 months
August 12, 2016
January 31, 2018
April 5, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Average AM and PM Subject-reported 12-hour Reflective Total Nasal Symptom Score (rTNSS)
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).
Baseline and day 14
Study Arms (4)
GSP 301 NS
EXPERIMENTALGOM-NS
ACTIVE COMPARATORGMM-2 NS
ACTIVE COMPARATORGSP 301 placebo NS
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (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
Investigational Site 403
Plymouth, Minnesota, United States
Investigational Site 443
Columbia, Missouri, United States
Investigational Site 441
Rolla, Missouri, United States
Investigational Site 440
St Louis, Missouri, United States
Investigational Site 405
Bellevue, Nebraska, United States
Investigational Site 434
Skillman, New Jersey, United States
Investigational Site 408
Rochester, New York, United States
Investigational Site 418
Rockville Centre, New York, United States
Investigational Site 402
High Point, North Carolina, United States
Investigational Site 427
Raleigh, North Carolina, United States
Investigational Site 419
Cincinnati, Ohio, United States
United States 404
Cincinnati, Ohio, United States
United States 407
Edmond, Oklahoma, United States
Investigational Site 410
Oklahoma City, Oklahoma, United States
Investigational Site 424
Tulsa, Oklahoma, United States
Investigational Site 411
Pittsburgh, Pennsylvania, United States
Investigational Site 416
Spartanburg, South Carolina, United States
Investigational Site 415
Austin, Texas, United States
Investigational Site 442
Austin, Texas, United States
Investigational Site 417
Boerne, Texas, United States
Investigational Site 421
Dallas, Texas, United States
Investigational Site 430
Dallas, Texas, United States
Investigational Site 431
El Paso, Texas, United States
Investigational Site 433
Kerrville, Texas, United States
Investigational Site 422
New Braunfels, Texas, United States
Investigational Site 401
San Antonio, Texas, United States
Investigational Site 413
San Antonio, Texas, United States
Investigational Site 425
San Antonio, Texas, United States
Investigational Site 437
San Antonio, Texas, United States
Investigational Site 400
Waco, Texas, United States
Investigational Site 409
Waco, Texas, United States
Investigational Site 423
Draper, Utah, United States
Investigational Site 439
Greenfield, Wisconsin, United States
Related Publications (1)
Gross GN, Berman G, Amar NJ, Caracta CF, Tantry SK. Efficacy and safety of olopatadine-mometasone combination nasal spray for the treatment of seasonal allergic rhinitis. Ann Allergy Asthma Immunol. 2019 Jun;122(6):630-638.e3. doi: 10.1016/j.anai.2019.03.017. Epub 2019 Mar 22.
PMID: 30910440DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Glenmark Pharmaceuticals Ltd
Study Officials
- STUDY DIRECTOR
Sudeesh Tantry, PhD
Glenmark Pharmaceuticals Ltd
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 12, 2016
First Posted
August 17, 2016
Study Start
August 1, 2016
Primary Completion
January 1, 2017
Study Completion
January 1, 2017
Last Updated
April 6, 2018
Results First Posted
April 6, 2018
Record last verified: 2018-04