Clinical trial NCT02631551: Efficacy and Safety of Fixed Dose Combination GSP 301 Nasal Spray (NS) in the Treatment of Seasonal Allergic Rhinitis (SAR)
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Seasonal Allergic Rhinitis
Keywords: Seasonal Allergic Rhinitis
Lead sponsor: Glenmark Specialty S.A.
Sponsor class: INDUSTRY
First posted: 2015-12-16
Enrollment: 1180
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 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


Eligibility criteria: Inclusion Criteria:

1. Aged 12 years and older inclusive of either sex.
2. 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)
3. 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).

Exclusion Criteria:

1. Pregnant or lactating women.
2. Plans to travel outside the known pollen area for the investigative site for \> 24 hours during the last 7 days of run in period.
3. History of anaphylaxis and/or other severe local reaction(s) to skin testing.
4. History of positive test for HIV, Hepatitis B or Hepatitis C infection.
5. Documented evidence of acute or significant chronic sinusitis or chronic purulent postnasal drip.
6. Subjects with an active pulmonary disorder or infection.
7. Subjects with posterior subcapsular cataracts or glaucoma

Primary outcomes:
measure: Change in Average AM and PM Subject-reported 12-hour Reflective Total Nasal Symptoms Score (rTNSS) From Baseline to End of Treatment.
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Mission Viejo
country: United States
facility: Investigational Site 20
state: California
city: San Diego
country: United States
facility: Investigational Site 31
state: California
city: San Jose
country: United States
facility: Investigational Site 29
state: California
city: Centennial
country: United States
facility: Investigational Site 25
state: Colorado
city: Colorado Springs
country: United States
facility: Investigational Site 22
state: Colorado
city: Jupiter
country: United States
facility: Investigational Site 10
state: Florida
city: Miami
country: United States
facility: Investigational Site 30
state: Florida
city: Marietta
country: United States
facility: Investigational Site 37
state: Georgia
city: Stockbridge
country: United States
facility: Investigational Site 15
state: Georgia
city: Stockbridge
country: United States
facility: Investigational Site 23
state: Georgia
city: Louisville
country: United States
facility: Investigational Site 11
state: Kentucky
city: Baltimore
country: United States
facility: Investigational Site 14
state: Maryland
city: Wheaton
country: United States
facility: Investigational Site 33
state: Maryland
city: Ypsilanti
country: United States
facility: Investigational Site 26
state: Michigan
city: Minneapolis
country: United States
facility: Investigational Site 19
state: Minnesota
city: Saint Louis
country: United States
facility: Investigational Site 21
state: Missouri
city: Bellevue
country: United States
facility: Investigational Site 16
state: Nebraska
city: Skillman
country: United States
facility: Investigational Site 12
state: New Jersey
city: Rochester
country: United States
facility: Investigational Site 36
state: New York
city: Raleigh
country: United States
facility: Investigational Site 18
state: North Carolina
city: Cincinnati
country: United States
facility: Investigational Site 27
state: Ohio
city: Middleburg Heights
country: United States
facility: Investigational Site 34
state: Ohio
city: Medford
country: United States
facility: Investigational Site 32
state: Oregon
city: Portland
country: United States
facility: Investigational Site 35
state: Oregon
city: Orangeburg
country: United States
facility: Investigational Site 13
state: South Carolina
city: Spartanburg
country: United States
facility: Investigational Site 17
state: South Carolina
city: Austin
country: United States
facility: Investigational Site 3
state: Texas
city: Austin
country: United States
facility: Investigational Site 5
state: Texas
city: Austin
country: United States
facility: Investigational Site 8
state: Texas
city: Kerrville
country: United States
facility: Investigational Site 1
state: Texas
city: New Braunfels
country: United States
facility: Investigational Site 7
state: Texas
city: San Antonio
country: United States
facility: Investigational Site 2
state: Texas
city: San Antonio
country: United States
facility: Investigational Site 4
state: Texas
city: San Antonio
country: United States
facility: Investigational Site 6
state: Texas
city: San Antonio
country: United States
facility: Investigational Site 9
state: Texas
city: Waco
country: United States
facility: Investigational Site 28
state: Texas
city: Draper
country: United States
facility: Investigational Site 24
state: Utah
Study officials:
affiliation: Glenmark Pharmaceuticals
name: Sudeesh Tantry, PhD
role: STUDY_DIRECTOR
References:
citation: 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.