Efficacy and Safety of Fixed Dose Combination GSP 301 Nasal Spray (NS) in the Treatment of Seasonal Allergic Rhinitis (SAR)
- Conditions
- Seasonal Allergic Rhinitis
- Interventions
- Registration Number
- NCT02631551
- Lead Sponsor
- Glenmark Specialty S.A.
- Brief Summary
Study to evaluate the efficacy and safety of GSP 301 NS compared to placebo NS and to individual monotherapies (comparators) as well as the efficacy of these monotherapies (comparators) versus placebo NS over 14 days of study treatment
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1180
- Aged 12 years and older inclusive of either sex.
- Documented clinical history of SAR (for at least 2 years preceding the Screening Visit [Visit 1]) with exacerbations (clinical evidence of active symptoms) during the spring allergy season (tree/grass pollen)
- A 12-hour reflective TNSS ≥ 8 out of a possible 12 and a congestion score of ≥ 2 for the AM assessment at the Screening Visit (Visit 1).
- Pregnant or lactating women.
- Plans to travel outside the known pollen area for the investigative site for > 24 hours during the last 7 days of run in period.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description GSP 301 Placebo NS GSP 301 Placebo NS - Olopatadine HCl NS Olopatadine HCl NS - GSP 301 NS GSP 301 NS - Mometasone furoate NS Mometasone furoate NS -
- Primary Outcome Measures
Name Time Method Change in Average AM and PM Subject-reported 12-hour Reflective Total Nasal Symptoms Score (rTNSS) From Baseline to End of Treatment. 14 days Reflective Total Nasal Symptom Score (rTNSS) was calculated as the sum of 12-hour reflective scoring of the severity of four nasal symptoms (nasal congestion, rhinorrhea, nasal itching, sneezing). Subjects responded on a 4-point severity scale with scores ranging 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 (37)
Investigational Site 20
🇺🇸Mission Viejo, California, United States
Investigational Site 25
🇺🇸Centennial, Colorado, United States
Investigational Site 31
🇺🇸San Diego, California, United States
Investigational Site 29
🇺🇸San Jose, California, United States
Investigational Site 37
🇺🇸Marietta, Georgia, United States
Investigational Site 15
🇺🇸Stockbridge, Georgia, United States
Investigational Site 30
🇺🇸Miami, Florida, United States
Investigational Site 23
🇺🇸Stockbridge, Georgia, United States
Investigational Site 33
🇺🇸Wheaton, Maryland, United States
Investigational Site 21
🇺🇸Saint Louis, Missouri, United States
Investigational Site 11
🇺🇸Louisville, Kentucky, United States
Investigational Site 14
🇺🇸Baltimore, Maryland, United States
Investigational Site 36
🇺🇸Rochester, New York, United States
Investigational Site 26
🇺🇸Ypsilanti, Michigan, United States
Investigational Site 34
🇺🇸Middleburg Heights, Ohio, United States
Investigational Site 18
🇺🇸Raleigh, North Carolina, United States
Investigational Site 27
🇺🇸Cincinnati, Ohio, United States
Investigational Site 3
🇺🇸Austin, Texas, United States
Investigational Site 5
🇺🇸Austin, Texas, United States
Investigational Site 2
🇺🇸San Antonio, Texas, United States
Investigational Site 8
🇺🇸Austin, Texas, United States
Investigational Site 1
🇺🇸Kerrville, Texas, United States
Investigational Site 4
🇺🇸San Antonio, Texas, United States
Investigational Site 7
🇺🇸New Braunfels, Texas, United States
Investigational Site 9
🇺🇸San Antonio, Texas, United States
Investigational Site 28
🇺🇸Waco, Texas, United States
Investigational Site 24
🇺🇸Draper, Utah, United States
Investigational Site 22
🇺🇸Colorado Springs, Colorado, United States
Investigational Site 12
🇺🇸Skillman, New Jersey, United States
Investigational Site 17
🇺🇸Spartanburg, South Carolina, United States
Investigational Site 35
🇺🇸Portland, Oregon, United States
Investigational Site 13
🇺🇸Orangeburg, South Carolina, United States
Investigational Site 32
🇺🇸Medford, Oregon, United States
Investigational Site 16
🇺🇸Bellevue, Nebraska, United States
Investigational Site 19
🇺🇸Minneapolis, Minnesota, United States
Investigational Site 6
🇺🇸San Antonio, Texas, United States
Investigational Site 10
🇺🇸Jupiter, Florida, United States