Clinical trial NCT03463031: Efficacy and Safety of GSP 301 Nasal Spray in Children (Aged 6 to Under 12 Years) With Seasonal Allergic Rhinitis (SAR)
Official title: A Double-Blind, Randomized, Parallel-Group Study to Evaluate the Efficacy, Safety and Tolerability of Fixed Dose Combination GSP 301 Nasal Spray Compared With Placebo Nasal Spray in Pediatric Subjects (Aged 6 to Under 12 Years) With Seasonal Allergic Rhinitis (SAR)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Seasonal Allergic Rhinitis (SAR)
Keywords: GSP 301 nasal spray for the treatment of Seasonal Allergic Rhinitis
Lead sponsor: Glenmark Specialty S.A.
Sponsor class: INDUSTRY
First posted: 2018-03-13
Enrollment: 446
Sex: ALL
Minimum age (years): 6
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Study to evaluate the efficacy, safety and tolerability of GSP 301 nasal spray (NS) compared with placebo NS in pediatric subjects (aged 6 to under 12 years) with Seasonal Allergic Rhinitis (SAR).


Eligibility criteria: Inclusion Criteria:

1. Male and female subjects aged ≥6 to \<12 years
2. Clinical history of SAR (at least 2 years) with exacerbations during the study season for the relevant seasonal allergen (e.g., tree/grass pollen)
3. Demonstrated sensitivity to at least 1 seasonal allergen through positive skin prick test within 12 months prior to screening
4. A 12-hour rTNSS value ≥6 out of a possible 12 for the morning assessment at screening
5. Signed informed consent/assent form (subject and parent/caregiver/legal guardian)

Exclusion Criteria:

1. Females of childbearing potential or pregnant
2. Plans to travel outside the known pollen area for the investigational site for 24 hours or longer during the last 7 days of the run-in period.
3. History of anaphylaxis and/or other severe local reaction(s) to skin testing
4. History and evidence of acute or significant chronic sinusitis or chronic purulent post nasal drip
5. Subjects with an active pulmonary disorder or infection.
6. Subjects with posterior subcapsular cataracts or glaucoma

Primary outcomes:
measure: Change From Baseline in Average AM and PM Subject-reported 12-hour Reflective Total Nasal Symptom Score ( rTNSS) Over the 14-day Treatment Period
timeFrame: Baseline and day 14
Secondary outcomes:
measure: Change From Baseline in Average AM and PM Subject-reported 12-hour Instantaneous Total Nasal Symptom Score (iTNSS) Over the 14-day Treatment Period.
timeFrame: Baseline and day 14
measure: Change From Baseline in the Overall Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) Score on Day 15 (Visit 4)
timeFrame: Baseline and day 15
measure: Change From Baseline in Average AM and PM Subject-reported 12-hour Reflective Total Ocular Symptom Score (rTOSS) Over the 14-day Treatment Period.
timeFrame: Baseline and day 14
Other outcomes:
Locations:
city: Mission Viejo
country: United States
facility: Glenmark Investigational Site 18
state: California
city: Ontario
country: United States
facility: Glenmark Investigational Site 32
state: California
city: Paramount
country: United States
facility: Glenmark Investigational Site 30
state: California
city: San Diego
country: United States
facility: Glenmark Investigational Site 17
state: California
city: Colorado Springs
country: United States
facility: Glenmark Investigational Site 21
state: Colorado
city: Marietta
country: United States
facility: Glenmark Investigational Site 13
state: Georgia
city: Savannah
country: United States
facility: Glenmark Investigational Site 26
state: Georgia
city: Louisville
country: United States
facility: Glenmark Investigational Site 28
state: Kentucky
city: Baltimore
country: United States
facility: Glenmark Investigational Site 14
state: Maryland
city: Bethesda
country: United States
facility: Glenmark Investigational Site 19
state: Maryland
city: Ypsilanti
country: United States
facility: Glenmark Investigational Site 25
state: Michigan
city: Columbia
country: United States
facility: Glenmark Investigational Site 12
state: Missouri
city: Rolla
country: United States
facility: Glenmark Investigational Site 10
state: Missouri
city: Warrensburg
country: United States
facility: Glenmark Investigational Site 27
state: Missouri
city: Omaha
country: United States
facility: Glenmark Investigational Site 15
state: Nebraska
city: High Point
country: United States
facility: Glenmark Investigational Site 3
state: North Carolina
city: Raleigh
country: United States
facility: Glenmark Investigational Site 8
state: North Carolina
city: Cincinnati
country: United States
facility: Glenmark Investigational Site 11
state: Ohio
city: Cincinnati
country: United States
facility: Glenmark Investigational Site 29
state: Ohio
city: Edmond
country: United States
facility: Glenmark Investigational Site 2
state: Oklahoma
city: Tulsa
country: United States
facility: Glenmark Investigational Site 33
state: Oklahoma
city: Medford
country: United States
facility: Glenmark Investigational Site 4
state: Oregon
city: Spartanburg
country: United States
facility: Glenmark Investigational Site 6
state: South Carolina
city: Austin
country: United States
facility: Glenmark Investigational Site 5
state: Texas
city: Kerrville
country: United States
facility: Glenmark Investigational Site 24
state: Texas
city: New Braunfels
country: United States
facility: Glenmark Investigational Site 1
state: Texas
city: San Antonio
country: United States
facility: Glenmark Investigational Site 7
state: Texas
city: San Antonio
country: United States
facility: Glenmark Investigational Site 9
state: Texas
city: Waco
country: United States
facility: Glenmark Investigational Site 20
state: Texas
city: Waco
country: United States
facility: Glenmark Investigational Site 31
state: Texas
city: Draper
country: United States
facility: Glenmark Investigational Site 22
state: Utah
city: Greenfield
country: United States
facility: Glenmark Investigational Site 23
state: Wisconsin
Study officials:
affiliation: Glenmark Pharmaceuticals Ltd.
name: Sudeesh Tantry, PhD
role: STUDY_DIRECTOR
References:
citation: Prenner BM, Amar NJ, Hampel FC Jr, Caracta CF, Wu W. Efficacy and safety of GSP301 nasal spray in children aged 6 to 11 years with seasonal allergic rhinitis. Ann Allergy Asthma Immunol. 2022 Nov;129(5):618-626.e2. doi: 10.1016/j.anai.2022.07.029. Epub 2022 Aug 1.