Efficacy and Safety of GSP 301 Nasal Spray in Children (Aged 6 to Under 12 Years) With Seasonal Allergic Rhinitis (SAR)
NCT ID: NCT03463031
Last Updated: 2019-10-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
446 participants
INTERVENTIONAL
2018-03-16
2018-11-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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GSP 301 NS
Fixed dose combination of olopatadine hydrochloride 665 μg and mometasone furoate 25 μg NS
GSP 301 NS
1 spray in each nostril twice daily for 14 days
GSP 301 Placebo NS
GSP 301 Placebo nasal spray
GSP 301 Placebo NS
1 spray in each nostril twice daily for 14 days
Interventions
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GSP 301 NS
1 spray in each nostril twice daily for 14 days
GSP 301 Placebo NS
1 spray in each nostril twice daily for 14 days
Eligibility Criteria
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Inclusion Criteria
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
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
6 Years
11 Years
ALL
No
Sponsors
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Glenmark Specialty S.A.
INDUSTRY
Responsible Party
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Principal Investigators
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Sudeesh Tantry, PhD
Role: STUDY_DIRECTOR
Glenmark Pharmaceuticals Ltd.
Locations
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Glenmark Investigational Site 18
Mission Viejo, California, United States
Glenmark Investigational Site 32
Ontario, California, United States
Glenmark Investigational Site 30
Paramount, California, United States
Glenmark Investigational Site 17
San Diego, California, United States
Glenmark Investigational Site 21
Colorado Springs, Colorado, United States
Glenmark Investigational Site 13
Marietta, Georgia, United States
Glenmark Investigational Site 26
Savannah, Georgia, United States
Glenmark Investigational Site 28
Louisville, Kentucky, United States
Glenmark Investigational Site 14
Baltimore, Maryland, United States
Glenmark Investigational Site 19
Bethesda, Maryland, United States
Glenmark Investigational Site 25
Ypsilanti, Michigan, United States
Glenmark Investigational Site 12
Columbia, Missouri, United States
Glenmark Investigational Site 10
Rolla, Missouri, United States
Glenmark Investigational Site 27
Warrensburg, Missouri, United States
Glenmark Investigational Site 15
Omaha, Nebraska, United States
Glenmark Investigational Site 3
High Point, North Carolina, United States
Glenmark Investigational Site 8
Raleigh, North Carolina, United States
Glenmark Investigational Site 11
Cincinnati, Ohio, United States
Glenmark Investigational Site 29
Cincinnati, Ohio, United States
Glenmark Investigational Site 2
Edmond, Oklahoma, United States
Glenmark Investigational Site 33
Tulsa, Oklahoma, United States
Glenmark Investigational Site 4
Medford, Oregon, United States
Glenmark Investigational Site 6
Spartanburg, South Carolina, United States
Glenmark Investigational Site 5
Austin, Texas, United States
Glenmark Investigational Site 24
Kerrville, Texas, United States
Glenmark Investigational Site 1
New Braunfels, Texas, United States
Glenmark Investigational Site 7
San Antonio, Texas, United States
Glenmark Investigational Site 9
San Antonio, Texas, United States
Glenmark Investigational Site 20
Waco, Texas, United States
Glenmark Investigational Site 31
Waco, Texas, United States
Glenmark Investigational Site 22
Draper, Utah, United States
Glenmark Investigational Site 23
Greenfield, Wisconsin, United States
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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GSP 301-305
Identifier Type: -
Identifier Source: org_study_id
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