Clinical trial NCT02870205: Efficacy and Safety of GSP 301 Nasal Spray in the Treatment of Seasonal Allergic Rhinitis (SAR)
Official title: A Double-Blind, Randomized, Parallel-Group Seasonal Allergic Rhinitis (SAR) Study to Evaluate the Efficacy, Safety and Tolerability of GSP 301 Nasal Spray Compared With Placebo Nasal Spray and Individual Monotherapy Formulations (Olopatadine Hydrochloride Nasal Spray and Mometasone Furoate Nasal Spray) in Adult and Adolescent Subjects (12 Years of Age and Older)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Seasonal Allergic Rhinitis (SAR)
Lead sponsor: Glenmark Specialty S.A.
Sponsor class: INDUSTRY
First posted: 2016-08-17
Enrollment: 1176
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)


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.

Primary outcomes:
measure: Change From Baseline in Average AM and PM Subject-reported 12-hour Reflective Total Nasal Symptom Score (rTNSS)
timeFrame: Baseline and day 14
Secondary outcomes:
Other outcomes:
Locations:
city: Mission Viejo
country: United States
facility: Investigational Site 406
state: California
city: Orange
country: United States
facility: Investigational Site 414
state: California
city: San Diego
country: United States
facility: Investigational Site 435
state: California
city: Centennial
country: United States
facility: Investigational Site 420
state: Colorado
city: Colorado Springs
country: United States
facility: Investigational Site 444
state: Colorado
city: Aventura
country: United States
facility: Investigational Site 428
state: Florida
city: Miami
country: United States
facility: Investigational Site 412
state: Florida
city: Bethesda
country: United States
facility: Investigational Site 436
state: Maryland
city: South Dartmouth
country: United States
facility: Investigational Site 432
state: Massachusetts
city: Minneapolis
country: United States
facility: Investigational Site 426
state: Minnesota
city: Plymouth
country: United States
facility: Investigational Site 403
state: Minnesota
city: Columbia
country: United States
facility: Investigational Site 443
state: Missouri
city: Rolla
country: United States
facility: Investigational Site 441
state: Missouri
city: Saint Louis
country: United States
facility: Investigational Site 440
state: Missouri
city: Bellevue
country: United States
facility: Investigational Site 405
state: Nebraska
city: Skillman
country: United States
facility: Investigational Site 434
state: New Jersey
city: Rochester
country: United States
facility: Investigational Site 408
state: New York
city: Rockville Centre
country: United States
facility: Investigational Site 418
state: New York
city: High Point
country: United States
facility: Investigational Site 402
state: North Carolina
city: Raleigh
country: United States
facility: Investigational Site 427
state: North Carolina
city: Cincinnati
country: United States
facility: Investigational Site 419
state: Ohio
city: Cincinnati
country: United States
facility: United States 404
state: Ohio
city: Edmond
country: United States
facility: United States 407
state: Oklahoma
city: Oklahoma City
country: United States
facility: Investigational Site 410
state: Oklahoma
city: Tulsa
country: United States
facility: Investigational Site 424
state: Oklahoma
city: Pittsburgh
country: United States
facility: Investigational Site 411
state: Pennsylvania
city: Spartanburg
country: United States
facility: Investigational Site 416
state: South Carolina
city: Austin
country: United States
facility: Investigational Site 415
state: Texas
city: Austin
country: United States
facility: Investigational Site 442
state: Texas
city: Boerne
country: United States
facility: Investigational Site 417
state: Texas
city: Dallas
country: United States
facility: Investigational Site 421
state: Texas
city: Dallas
country: United States
facility: Investigational Site 430
state: Texas
city: El Paso
country: United States
facility: Investigational Site 431
state: Texas
city: Kerrville
country: United States
facility: Investigational Site 433
state: Texas
city: New Braunfels
country: United States
facility: Investigational Site 422
state: Texas
city: San Antonio
country: United States
facility: Investigational Site 401
state: Texas
city: San Antonio
country: United States
facility: Investigational Site 413
state: Texas
city: San Antonio
country: United States
facility: Investigational Site 425
state: Texas
city: San Antonio
country: United States
facility: Investigational Site 437
state: Texas
city: Waco
country: United States
facility: Investigational Site 400
state: Texas
city: Waco
country: United States
facility: Investigational Site 409
state: Texas
city: Draper
country: United States
facility: Investigational Site 423
state: Utah
city: Greenfield
country: United States
facility: Investigational Site 439
state: Wisconsin
Study officials:
affiliation: Glenmark Pharmaceuticals Ltd
name: Sudeesh Tantry, PhD
role: STUDY_DIRECTOR
References:
citation: Gross GN, Berman G, Amar NJ, Caracta CF, Tantry SK. Efficacy and safety of olopatadine-mometasone combination nasal spray for the treatment of seasonal allergic rhinitis. Ann Allergy Asthma Immunol. 2019 Jun;122(6):630-638.e3. doi: 10.1016/j.anai.2019.03.017. Epub 2019 Mar 22.