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

• Status: Completed
• Trial end date: 2017-01-01
• Target enrollment: 0
• Participant gender: All

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)

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Glenmark Specialty S.A.
• Treatments: Olopatadine Hydrochloride

Criteria

Inclusion Criteria:

• 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).

Exclusion Criteria:

• 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.