Efficacy and Safety of Fixed Dose Combination GSP 301 Nasal Spray (NS) in the Treatment of Seasonal Allergic Rhinitis (SAR)
GSP 301-301
A Double-Blind, Randomized, Parallel-Group, Comparative Study to Evaluate the Efficacy, Safety and Tolerability of a Fixed Dose Combination GSP 301 Nasal Spray (NS) Compared With Placebo Nasal Spray and Individual Monotherapy Formulations (Comparators) in Subjects (Aged 12 Years and Older) With Seasonal Allergic Rhinitis (SAR)
1 other identifier
interventional
1,180
1 country
37
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Mar 2016
Shorter than P25 for phase_3
37 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 10, 2015
CompletedFirst Posted
Study publicly available on registry
December 16, 2015
CompletedStudy Start
First participant enrolled
March 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2016
CompletedResults Posted
Study results publicly available
August 15, 2018
CompletedSeptember 25, 2018
August 1, 2018
4 months
December 10, 2015
July 18, 2018
August 28, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Average AM and PM Subject-reported 12-hour Reflective Total Nasal Symptoms Score (rTNSS) From Baseline to End of Treatment.
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).
14 days
Study Arms (4)
GSP 301 NS
EXPERIMENTALOlopatadine HCl NS
ACTIVE COMPARATORMometasone furoate NS
ACTIVE COMPARATORGSP 301 Placebo NS
PLACEBO COMPARATORInterventions
FDC of olopatadine HCl and mometasone furoate: 2 sprays in each nostril twice daily for 14 days
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (37)
Investigational Site 20
Mission Viejo, California, United States
Investigational Site 31
San Diego, California, United States
Investigational Site 29
San Jose, California, United States
Investigational Site 25
Centennial, Colorado, United States
Investigational Site 22
Colorado Springs, Colorado, United States
Investigational Site 10
Jupiter, Florida, United States
Investigational Site 30
Miami, Florida, United States
Investigational Site 37
Marietta, Georgia, United States
Investigational Site 15
Stockbridge, Georgia, United States
Investigational Site 23
Stockbridge, Georgia, United States
Investigational Site 11
Louisville, Kentucky, United States
Investigational Site 14
Baltimore, Maryland, United States
Investigational Site 33
Wheaton, Maryland, United States
Investigational Site 26
Ypsilanti, Michigan, United States
Investigational Site 19
Minneapolis, Minnesota, United States
Investigational Site 21
St Louis, Missouri, United States
Investigational Site 16
Bellevue, Nebraska, United States
Investigational Site 12
Skillman, New Jersey, United States
Investigational Site 36
Rochester, New York, United States
Investigational Site 18
Raleigh, North Carolina, United States
Investigational Site 27
Cincinnati, Ohio, United States
Investigational Site 34
Middleburg Heights, Ohio, United States
Investigational Site 32
Medford, Oregon, United States
Investigational Site 35
Portland, Oregon, United States
Investigational Site 13
Orangeburg, South Carolina, United States
Investigational Site 17
Spartanburg, South Carolina, United States
Investigational Site 3
Austin, Texas, United States
Investigational Site 5
Austin, Texas, United States
Investigational Site 8
Austin, Texas, United States
Investigational Site 1
Kerrville, Texas, United States
Investigational Site 7
New Braunfels, Texas, United States
Investigational Site 2
San Antonio, Texas, United States
Investigational Site 4
San Antonio, Texas, United States
Investigational Site 6
San Antonio, 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
Related Publications (1)
Hampel FC, Pedinoff AJ, Jacobs RL, Caracta CF, Tantry SK. Olopatadine-mometasone combination nasal spray: Evaluation of efficacy and safety in patients with seasonal allergic rhinitis. Allergy Asthma Proc. 2019 Jul 3;40(4):261-272. doi: 10.2500/aap.2019.40.4223. Epub 2019 May 3.
PMID: 31053180DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Glenmark Pharmaceuticals Ltd.
Study Officials
- STUDY DIRECTOR
Sudeesh Tantry, PhD
Glenmark Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 10, 2015
First Posted
December 16, 2015
Study Start
March 1, 2016
Primary Completion
July 1, 2016
Study Completion
July 1, 2016
Last Updated
September 25, 2018
Results First Posted
August 15, 2018
Record last verified: 2018-08