Clinical trial NCT02709538: Long Term Safety and Efficacy of Fixed Dose Combination GSP 301 Nasal Spray (NS) in the Treatment of Perennial Allergic Rhinitis (PAR)
Official title: A Double-Blind, Randomized, Parallel-Group Study to Evaluate Long-Term Safety, Tolerability, and Efficacy of a Fixed Dose Combination GSP 301 Nasal Spray Compared With Two Placebo Nasal Spray Formulations in Subjects (Aged 12 Years and Older) With Perennial Allergic Rhinitis (PAR)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Perennial Allergic Rhinitis
Lead sponsor: Glenmark Specialty S.A.
Sponsor class: INDUSTRY
First posted: 2016-03-16
Enrollment: 601
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: 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)


Eligibility criteria: Inclusion Criteria:

1. Aged ≥12 years and older inclusive of either sex.
2. 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:

1. Pregnant or lactating women.
2. History of anaphylaxis and/or other severe local reaction(s) to skin testing.
3. History of positive test for HIV, Hepatitis B or Hepatitis C infection.
4. Documented evidence of acute or significant chronic sinusitis or chronic purulent postnasal drip.
5. Subjects with an active pulmonary disorder or infection.
6. Subjects with posterior subcapsular cataracts or glaucoma

Primary outcomes:
measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs).
timeFrame: 52 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Hot Springs
country: United States
facility: Investigational Site 2
state: Arkansas
city: Encinitas
country: United States
facility: Investigational Site 28
state: California
city: San Diego
country: United States
facility: Investigational Site 27
state: California
city: San Diego
country: United States
facility: Investigational Site 29
state: California
city: Denver
country: United States
facility: Investigational Site 32
state: Colorado
city: Aventura
country: United States
facility: Investigational Site 26
state: Florida
city: Miami
country: United States
facility: Investigational Site 9
state: Florida
city: Tallahassee
country: United States
facility: Investigational Site 33
state: Florida
city: Stockbridge
country: United States
facility: Investigational Site 11
state: Georgia
city: Louisville
country: United States
facility: Investigational Site 4
state: Kentucky
city: Bethesda
country: United States
facility: Investigational Site 5
state: Maryland
city: Saint Louis
country: United States
facility: Investigational Site 15
state: Missouri
city: Bellevue
country: United States
facility: Investigational Site 30
state: Nebraska
city: Skillman
country: United States
facility: Investigational Site 19
state: New Jersey
city: Corning
country: United States
facility: Investigational Site 18
state: New York
city: High Point
country: United States
facility: Investigational Site 7
state: North Carolina
city: Raleigh
country: United States
facility: Investigational Site 21
state: North Carolina
city: Sylvania
country: United States
facility: Investigational Site 16
state: Ohio
city: Pittsburgh
country: United States
facility: Investigational Site 22
state: Pennsylvania
city: Spartanburg
country: United States
facility: Investigational Site 13
state: South Carolina
city: Austin
country: United States
facility: Investigational Site 23
state: Texas
city: Austin
country: United States
facility: Investigational Site 24
state: Texas
city: Austin
country: United States
facility: Investigational Site 3
state: Texas
city: Dallas
country: United States
facility: Investigational Site 31
state: Texas
city: El Paso
country: United States
facility: Investigational Site 34
state: Texas
city: Kerrville
country: United States
facility: Investigational Site 6
state: Texas
city: New Braunfels
country: United States
facility: Investigational Site 14
state: Texas
city: San Antonio
country: United States
facility: Investigational Site 10
state: Texas
city: San Antonio
country: United States
facility: Investigational Site 12
state: Texas
city: San Antonio
country: United States
facility: Investigational Site 17
state: Texas
city: San Antonio
country: United States
facility: Investigational Site 1
state: Texas
city: San Antonio
country: United States
facility: Investigational Site 20
state: Texas
city: Waco
country: United States
facility: Investigational Site 25
state: Texas
city: Waco
country: United States
facility: Investigational Site 8
state: Texas
Study officials:
affiliation: Glenmark Pharmaceuticals
name: Sudeesh Tantry
role: STUDY_DIRECTOR
References:
citation: Segall N, Prenner B, Lumry W, Caracta CF, Tantry SK. Long-term safety and efficacy of olopatadine-mometasone combination nasal spray in patients with perennial allergic rhinitis. Allergy Asthma Proc. 2019 Sep 1;40(5):301-310. doi: 10.2500/aap.2019.40.4233. Epub 2019 Jun 27.