Long Term Safety and Efficacy of Fixed Dose Combination GSP 301 Nasal Spray (NS) in the Treatment of Perennial Allergic Rhinitis (PAR)

Completed · Phase 3 · Has a placebo group

Conditions studied: Perennial Allergic Rhinitis

In brief

To evaluate the long term safety and efficacy of GSP 301 NS compared to 2 placebo NS formulations for the treatment of perennial allergic rhinitis (subjects 12 years of age and older)

Key facts

Study ID

NCT02709538

Run by

Glenmark Specialty S.A.

People needed

601

Starts

2016-04-01

Expected to finish

2017-07-01

Last updated by the study team

2020-02-26

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 PAR (for at least 2 years preceding the Screening Visit [Visit 1]) and exhibiting a documented positive skin prick test (wheal diameter at least 3 mm greater than negative diluent control wheal) to at least 1 allergen known to induce PAR. Documentation of a positive result within 12 months prior to the Screening Visit (Visit 1) is acceptable.

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

Where it is running

• Investigational Site 2 — Hot Springs, Arkansas, United States
• Investigational Site 28 — Encinitas, California, United States
• Investigational Site 27 — San Diego, California, United States
• Investigational Site 29 — San Diego, California, United States
• Investigational Site 32 — Denver, Colorado, United States
• Investigational Site 26 — Aventura, Florida, United States
• Investigational Site 9 — Miami, Florida, United States
• Investigational Site 33 — Tallahassee, Florida, United States
• Investigational Site 11 — Stockbridge, Georgia, United States
• Investigational Site 4 — Louisville, Kentucky, United States
• Investigational Site 5 — Bethesda, Maryland, United States
• Investigational Site 15 — St Louis, Missouri, United States
• Investigational Site 30 — Bellevue, Nebraska, United States
• Investigational Site 19 — Skillman, New Jersey, United States
• Investigational Site 18 — Corning, New York, United States
• Investigational Site 7 — High Point, North Carolina, United States
• Investigational Site 21 — Raleigh, North Carolina, United States
• Investigational Site 16 — Sylvania, Ohio, United States
• Investigational Site 22 — Pittsburgh, Pennsylvania, United States
• Investigational Site 13 — Spartanburg, South Carolina, United States
• Investigational Site 23 — Austin, Texas, United States
• Investigational Site 24 — Austin, Texas, United States
• Investigational Site 3 — Austin, Texas, United States
• Investigational Site 31 — Dallas, Texas, United States
• Investigational Site 34 — El Paso, Texas, United States

Full record on ClinicalTrials.gov

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