To Study GSP 301 in Patients With Seasonal Allergic Rhinitis
NCT ID: NCT02318303
Last Updated: 2020-10-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
1111 participants
INTERVENTIONAL
2014-12-31
2015-02-28
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
DOUBLE
Study Groups
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GSP 301 Placebo NS
GSP 301 Placebo NS
GSP 301 placebo NS administered as 2 sprays/nostril
GSP 301-1 NS (QD)
GSP 301-1 NS (QD)
GSP 301-1 NS (665 μg olopatadine hydrochloride/50 μg mometasone furoate) administered as 2 sprays/nostril
GSP 301-2 NS (BID)
GSP 301-2 NS (BID)
GSP 301-2 NS (665 μg olopatadine hydrochloride/25 μg mometasone furoate) administered as 2 sprays/nostril
Olopatadine HCl-1 NS (QD)
Olopatadine HCl-1 NS (QD)
Olopatadine HCl-1 NS (665 μg) administered as 2 sprays/nostril
Olopatadine HCl-2 NS (BID)
Olopatadine HCl-2 NS (BID)
Olopatadine HCl-2 NS (665 μg) administered as 2 sprays/nostril
Mometasone Furoate-1 NS (QD)
Mometasone Furoate-1 NS (QD)
Mometasone furoate -1 NS (50 μg) administered as 2 sprays/nostril
Mometasone Furoate-2 NS (BID)
Mometasone Furoate-2 NS (BID)
Mometasone furoate-2 NS (25 μg) administered as 2 sprays/nostril
Interventions
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GSP 301-1 NS (QD)
GSP 301-1 NS (665 μg olopatadine hydrochloride/50 μg mometasone furoate) administered as 2 sprays/nostril
GSP 301-2 NS (BID)
GSP 301-2 NS (665 μg olopatadine hydrochloride/25 μg mometasone furoate) administered as 2 sprays/nostril
GSP 301 Placebo NS
GSP 301 placebo NS administered as 2 sprays/nostril
Olopatadine HCl-1 NS (QD)
Olopatadine HCl-1 NS (665 μg) administered as 2 sprays/nostril
Olopatadine HCl-2 NS (BID)
Olopatadine HCl-2 NS (665 μg) administered as 2 sprays/nostril
Mometasone Furoate-1 NS (QD)
Mometasone furoate -1 NS (50 μg) administered as 2 sprays/nostril
Mometasone Furoate-2 NS (BID)
Mometasone furoate-2 NS (25 μg) administered as 2 sprays/nostril
Eligibility Criteria
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Inclusion Criteria
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 study season for the mountain cedar 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
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 nasal polyps of other clinically significant respiratory tract malformations, recent nasal biopsy, nasal trauma (such as nasal piercing) or surgery, atopic dermatitis or rhinitis medicamentosa.
4. History of anaphylaxis and/or other severe local reaction(s) to skin testing.
5. History of positive test for HIV, Hepatitis B or Hepatitis C infection.
6. Documented evidence of acute or significant chronic sinusitis or chronic purulent postnasal drip.
7. Subjects with an active pulmonary disorder or infection.
8. Subjects with posterior subcapsular cataracts or glaucoma.
12 Years
ALL
No
Sponsors
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Glenmark Pharmaceuticals Ltd. India
INDUSTRY
Responsible Party
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Principal Investigators
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Sudeesh Tantry, Ph.D
Role: STUDY_DIRECTOR
Glenmark Pharmaceuticals Ltd
Locations
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Glenmark Investigational Site 10
Austin, Texas, United States
Glenmark Investigational Site 5
Austin, Texas, United States
Glenmark Investigational Site 6
Austin, Texas, United States
Glenmark Investigational Site 2
Kerrville, Texas, United States
Glenmark Investigational Site 7
New Braunfels, Texas, United States
Glenmark Investigational Site 3
San Antonio, Texas, United States
Glenmark Investigational Site 4
San Antonio, Texas, United States
Glenmark Investigational Site 8
San Antonio, Texas, United States
Glenmark Investigational Site 9
San Antonio, Texas, United States
Glenmark Investigational Site 1
Waco, Texas, United States
Countries
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References
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Andrews CP, Mohar D, Salhi Y, Tantry SK. Efficacy and safety of twice-daily and once-daily olopatadine-mometasone combination nasal spray for seasonal allergic rhinitis. Ann Allergy Asthma Immunol. 2020 Feb;124(2):171-178.e2. doi: 10.1016/j.anai.2019.11.007. Epub 2019 Nov 15.
Other Identifiers
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IND Number: 123164
Identifier Type: OTHER
Identifier Source: secondary_id
Study Number (GSP 301-201)
Identifier Type: OTHER
Identifier Source: secondary_id
GPL/CT/2014/004/II
Identifier Type: -
Identifier Source: org_study_id
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