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

Completed · Phase 3 · Has a placebo group

Conditions studied: Seasonal Allergic Rhinitis (SAR)

In brief

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)

Key facts

Study ID

NCT02870205

Run by

Glenmark Specialty S.A.

People needed

1176

Starts

2016-08-01

Expected to finish

2017-01-01

Last updated by the study team

2018-04-06

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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