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

Launched by GLENMARK SPECIALTY S.A. · Aug 12, 2016

Keywords

ClinConnect Summary

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Gender

ALL

Eligibility 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.