Efficacy and Safety of GSP 301 Nasal Spray in the Treatment of Seasonal Allergic Rhinitis (SAR)
NCT ID: NCT02870205
Last Updated: 2018-04-06
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
1176 participants
INTERVENTIONAL
2016-08-31
2017-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Efficacy and Safety of Fixed Dose Combination GSP 301 Nasal Spray (NS) in the Treatment of Seasonal Allergic Rhinitis (SAR)
NCT02631551
To Study GSP 301 in Patients With Seasonal Allergic Rhinitis
NCT02318303
Efficacy and Safety of GSP 301 Nasal Spray in Children (Aged 6 to Under 12 Years) With Seasonal Allergic Rhinitis (SAR)
NCT03463031
Long Term Safety and Efficacy of Fixed Dose Combination GSP 301 Nasal Spray (NS) in the Treatment of Perennial Allergic Rhinitis (PAR)
NCT02709538
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)
NCT03444506
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
GSP 301 NS
GSP 301 NS
2 spray in each nostril twice daily for 14 days
GOM-NS
GOM-NS
2 spray in each nostril twice daily for 14 days
GMM-2 NS
GMM-2 NS
2 spray in each nostril twice daily for 14 days
GSP 301 placebo NS
GSP 301 placebo NS
2 spray in each nostril twice daily for 14 days
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
GSP 301 NS
2 spray in each nostril twice daily for 14 days
GOM-NS
2 spray in each nostril twice daily for 14 days
GMM-2 NS
2 spray in each nostril twice daily for 14 days
GSP 301 placebo NS
2 spray in each nostril twice daily for 14 days
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
12 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Glenmark Specialty S.A.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Sudeesh Tantry, PhD
Role: STUDY_DIRECTOR
Glenmark Pharmaceuticals Ltd
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Related Links
Access external resources that provide additional context or updates about the study.
Poster presentation at the "2017 Annual Scientific Meeting of the American College of Allergy, Asthma, and Immunology"
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Study Number: GSP 301-304
Identifier Type: OTHER
Identifier Source: secondary_id
GPL/CT/2015/004/III
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.