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

Completed · Phase 3 · Has a placebo group

Conditions studied: Seasonal Allergic Rhinitis

In brief

Study to evaluate the efficacy and safety of GSP 301 NS compared to placebo NS and to individual monotherapies (comparators) as well as the efficacy of these monotherapies (comparators) versus placebo NS over 14 days of study treatment

Key facts

Study ID

NCT02631551

Run by

Glenmark Specialty S.A.

People needed

1180

Starts

2016-03-01

Expected to finish

2016-07-01

Last updated by the study team

2018-09-25

Who can join

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

You may qualify if…

• Aged 12 years and older inclusive of either sex.
• Documented clinical history of SAR (for at least 2 years preceding the Screening Visit [Visit 1]) with exacerbations (clinical evidence of active symptoms) during the spring allergy season (tree/grass pollen)
• A 12-hour reflective TNSS ≥ 8 out of a possible 12 and a congestion score of ≥ 2 for the AM assessment at the Screening Visit (Visit 1).

You may not qualify if…

• Pregnant or lactating women.
• Plans to travel outside the known pollen area for the investigative site for > 24 hours during the last 7 days of run in period.
• 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

Where it is running

• Investigational Site 20 — Mission Viejo, California, United States
• Investigational Site 31 — San Diego, California, United States
• Investigational Site 29 — San Jose, California, United States
• Investigational Site 25 — Centennial, Colorado, United States
• Investigational Site 22 — Colorado Springs, Colorado, United States
• Investigational Site 10 — Jupiter, Florida, United States
• Investigational Site 30 — Miami, Florida, United States
• Investigational Site 37 — Marietta, Georgia, United States
• Investigational Site 15 — Stockbridge, Georgia, United States
• Investigational Site 23 — Stockbridge, Georgia, United States
• Investigational Site 11 — Louisville, Kentucky, United States
• Investigational Site 14 — Baltimore, Maryland, United States
• Investigational Site 33 — Wheaton, Maryland, United States
• Investigational Site 26 — Ypsilanti, Michigan, United States
• Investigational Site 19 — Minneapolis, Minnesota, United States
• Investigational Site 21 — St Louis, Missouri, United States
• Investigational Site 16 — Bellevue, Nebraska, United States
• Investigational Site 12 — Skillman, New Jersey, United States
• Investigational Site 36 — Rochester, New York, United States
• Investigational Site 18 — Raleigh, North Carolina, United States
• Investigational Site 27 — Cincinnati, Ohio, United States
• Investigational Site 34 — Middleburg Heights, Ohio, United States
• Investigational Site 32 — Medford, Oregon, United States
• Investigational Site 35 — Portland, Oregon, United States
• Investigational Site 13 — Orangeburg, South Carolina, United States

Full record on ClinicalTrials.gov

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