Long Term Safety and Efficacy of Fixed Dose Combination GSP 301 Nasal Spray (NS) in the Treatment of Perennial Allergic Rhinitis (PAR)

Phase 3

Completed

Conditions: Perennial Allergic Rhinitis

Interventions: Drug: GSP 301 NS
Drug: GSP 301 Placebo NS pH 7.0
Drug: GSP 301 Placebo NS pH 3.7

Registration Number: NCT02709538

Lead Sponsor: Glenmark Specialty S.A.

Brief Summary: To evaluate the long term safety and efficacy of GSP 301 NS compared to 2 placebo NS formulations for the treatment of perennial allergic rhinitis (subjects 12 years of age and older)

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 601

Inclusion Criteria

Aged ≥12 years and older inclusive of either sex.
Documented clinical history of PAR (for at least 2 years preceding the Screening Visit [Visit 1]) and exhibiting a documented positive skin prick test (wheal diameter at least 3 mm greater than negative diluent control wheal) to at least 1 allergen known to induce PAR. Documentation of a positive result within 12 months prior to the Screening Visit (Visit 1) is acceptable.

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GSP 301 NS	GSP 301 NS	-
GSP 301 Placebo NS pH 7.0	GSP 301 Placebo NS pH 7.0	-
GSP 301 Placebo NS pH 3.7	GSP 301 Placebo NS pH 3.7	-

Primary Outcome Measures

Name	Time	Method
Number of Participants With Treatment-emergent Adverse Events (TEAEs).	52 weeks	All TEAEs and serious adverse events (SAEs) occurring in the study, in terms of nature, onset, duration, severity, relationship, and outcome were reported.

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (34): Investigational Site 33
🇺🇸
Tallahassee, Florida, United States
Investigational Site 2
🇺🇸
Hot Springs, Arkansas, United States
Investigational Site 30
🇺🇸
Bellevue, Nebraska, United States
Investigational Site 27
🇺🇸
San Diego, California, United States
Investigational Site 26
🇺🇸
Aventura, Florida, United States
Investigational Site 29
🇺🇸
San Diego, California, United States
Investigational Site 5
🇺🇸
Bethesda, Maryland, United States
Investigational Site 18
🇺🇸
Corning, New York, United States
Investigational Site 13
🇺🇸
Spartanburg, South Carolina, United States
Investigational Site 32
🇺🇸
Denver, Colorado, United States
Investigational Site 28
🇺🇸
Encinitas, California, United States
Investigational Site 11
🇺🇸
Stockbridge, Georgia, United States
Investigational Site 9
🇺🇸
Miami, Florida, United States
Investigational Site 22
🇺🇸
Pittsburgh, Pennsylvania, United States
Investigational Site 19
🇺🇸
Skillman, New Jersey, United States
Investigational Site 21
🇺🇸
Raleigh, North Carolina, United States
Investigational Site 7
🇺🇸
High Point, North Carolina, United States
Investigational Site 34
🇺🇸
El Paso, Texas, United States
Investigational Site 24
🇺🇸
Austin, Texas, United States
Investigational Site 10
🇺🇸
San Antonio, Texas, United States
Investigational Site 25
🇺🇸
Waco, Texas, United States
Investigational Site 4
🇺🇸
Louisville, Kentucky, United States
Investigational Site 6
🇺🇸
Kerrville, Texas, United States
Investigational Site 3
🇺🇸
Austin, Texas, United States
Investigational Site 16
🇺🇸
Sylvania, Ohio, United States
Investigational Site 14
🇺🇸
New Braunfels, Texas, United States
Investigational Site 17
🇺🇸
San Antonio, Texas, United States
Investigational Site 8
🇺🇸
Waco, Texas, United States
Investigational Site 1
🇺🇸
San Antonio, Texas, United States
Investigational Site 15
🇺🇸
Saint Louis, Missouri, United States
Investigational Site 12
🇺🇸
San Antonio, Texas, United States
Investigational Site 23
🇺🇸
Austin, Texas, United States
Investigational Site 20
🇺🇸
San Antonio, Texas, United States
Investigational Site 31
🇺🇸
Dallas, Texas, United States