Efficacy and Safety of GSP 301 Nasal Spray in the Treatment of Seasonal Allergic Rhinitis (SAR) (GSP 301-304)

Glenmark Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Seasonal Allergic Rhinitis (SAR)

Treatments: Drug: GSP 301 placebo NS; Drug: GMM-2 NS; Drug: GSP 301 NS; Drug: GOM-NS

Study type: Interventional

Funder types: Industry

Identifiers

NCT02870205

GPL/CT/2015/004/III

Study Number: GSP 301-304 (Other Identifier)

Details and patient eligibility

About

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)

Enrollment: 1,176 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,176 participants in 4 patient groups, including a placebo group

GSP 301 NS

Experimental group

Treatment:

Drug: GSP 301 NS

GOM-NS

Active Comparator group

Treatment:

Drug: GOM-NS

GMM-2 NS

Active Comparator group

Treatment:

Drug: GMM-2 NS

GSP 301 placebo NS

Placebo Comparator group

Treatment:

Drug: GSP 301 placebo NS