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

Phase 3

Completed

Conditions: Seasonal Allergic Rhinitis (SAR)

Interventions: Drug: GSP 301 placebo NS
Drug: GOM-NS
Drug: GSP 301 NS
Drug: GMM-2 NS

Registration Number: NCT02870205

Lead Sponsor: Glenmark Specialty S.A.

Brief 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)

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 1176

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GSP 301 placebo NS	GSP 301 placebo NS	-
GOM-NS	GOM-NS	-
GSP 301 NS	GSP 301 NS	-
GMM-2 NS	GMM-2 NS	-

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Average AM and PM Subject-reported 12-hour Reflective Total Nasal Symptom Score (rTNSS)	Baseline and day 14	The Reflective Total Nasal Symptom Score (rTNSS) was assessed by 12-hour reflective scoring of the severity of four nasal symptoms (rhinorrhea, sneezing, nasal congestion, nasal itching). Symptom scores ranged from 0 (no signs/symptoms evident) to 3 (severe signs/symptoms that is hard to tolerate). The rTNSS was calculated as the sum of the subject-reported severity scores for nasal symptoms, and value ranged from 0 (no signs/symptoms evident) to 12 (severe signs/symptoms that is hard to tolerate).

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (43): Investigational Site 428
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Aventura, Florida, United States
Investigational Site 430
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Dallas, Texas, United States
United States 407
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Edmond, Oklahoma, United States
Investigational Site 427
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Raleigh, North Carolina, United States
Investigational Site 418
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Rockville Centre, New York, United States
Investigational Site 441
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Rolla, Missouri, United States
Investigational Site 431
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El Paso, Texas, United States
Investigational Site 421
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Dallas, Texas, United States
Investigational Site 400
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Waco, Texas, United States
Investigational Site 443
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Columbia, Missouri, United States
Investigational Site 422
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New Braunfels, Texas, United States
Investigational Site 424
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Tulsa, Oklahoma, United States
Investigational Site 433
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Kerrville, Texas, United States
Investigational Site 411
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Pittsburgh, Pennsylvania, United States
Investigational Site 403
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Plymouth, Minnesota, United States
Investigational Site 444
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Colorado Springs, Colorado, United States
Investigational Site 406
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Mission Viejo, California, United States
Investigational Site 414
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Orange, California, United States
Investigational Site 420
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Centennial, Colorado, United States
Investigational Site 412
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Miami, Florida, United States
Investigational Site 432
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South Dartmouth, Massachusetts, United States
Investigational Site 440
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Saint Louis, Missouri, United States
Investigational Site 408
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Rochester, New York, United States
Investigational Site 402
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High Point, North Carolina, United States
Investigational Site 417
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Boerne, Texas, United States
Investigational Site 405
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Bellevue, Nebraska, United States
Investigational Site 439
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Greenfield, Wisconsin, United States
Investigational Site 434
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Skillman, New Jersey, United States
Investigational Site 416
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Spartanburg, South Carolina, United States
Investigational Site 423
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Draper, Utah, United States
Investigational Site 409
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Waco, Texas, United States
Investigational Site 436
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Bethesda, Maryland, United States
United States 404
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Cincinnati, Ohio, United States
Investigational Site 401
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San Antonio, Texas, United States
Investigational Site 426
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Minneapolis, Minnesota, United States
Investigational Site 419
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Cincinnati, Ohio, United States
Investigational Site 410
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Oklahoma City, Oklahoma, United States
Investigational Site 442
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Austin, Texas, United States
Investigational Site 425
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San Antonio, Texas, United States
Investigational Site 437
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San Antonio, Texas, United States
Investigational Site 413
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San Antonio, Texas, United States
Investigational Site 435
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San Diego, California, United States
Investigational Site 415
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Austin, Texas, United States