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

NCT ID: NCT02709538

Last Updated: 2020-02-26

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

601 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2017-07-31

Brief Summary

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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)

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Efficacy and Safety of GSP 301 Nasal Spray in the Treatment of Seasonal Allergic Rhinitis (SAR)

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Efficacy and Safety of GSP 301 Nasal Spray in Children (Aged 6 to Under 12 Years) With Seasonal Allergic Rhinitis (SAR)

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Once-Daily Investigational Nasal Spray In Adults And Adolescents With Perennial Allergic Rhinitis (PAR)

NCT00289198

Rhinitis, Allergic, Perennial
COMPLETED PHASE3

Detailed Description

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Conditions

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Perennial Allergic Rhinitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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GSP 301 NS

Group Type EXPERIMENTAL

GSP 301 NS

Intervention Type DRUG

FDC of olopatadine HCl and mometasone furoate: 2 spray in each nostril twice daily for 52 weeks

GSP 301 Placebo NS pH 3.7

Group Type PLACEBO_COMPARATOR

GSP 301 Placebo NS pH 3.7

Intervention Type DRUG

2 spray in each nostril twice daily for 52 weeks

GSP 301 Placebo NS pH 7.0

Group Type PLACEBO_COMPARATOR

GSP 301 Placebo NS pH 7.0

Intervention Type DRUG

2 spray in each nostril twice daily for 52 weeks

Interventions

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GSP 301 NS

FDC of olopatadine HCl and mometasone furoate: 2 spray in each nostril twice daily for 52 weeks

Intervention Type DRUG

GSP 301 Placebo NS pH 3.7

2 spray in each nostril twice daily for 52 weeks

Intervention Type DRUG

GSP 301 Placebo NS pH 7.0

2 spray in each nostril twice daily for 52 weeks

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Glenmark Specialty S.A.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sudeesh Tantry

Role: STUDY_DIRECTOR

Glenmark Pharmaceuticals

Locations

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Investigational Site 2

Hot Springs, Arkansas, United States

Site Status

Investigational Site 28

Encinitas, California, United States

Site Status

Investigational Site 27

San Diego, California, United States

Site Status

Investigational Site 29

San Diego, California, United States

Site Status

Investigational Site 32

Denver, Colorado, United States

Site Status

Investigational Site 26

Aventura, Florida, United States

Site Status

Investigational Site 9

Miami, Florida, United States

Site Status

Investigational Site 33

Tallahassee, Florida, United States

Site Status

Investigational Site 11

Stockbridge, Georgia, United States

Site Status

Investigational Site 4

Louisville, Kentucky, United States

Site Status

Investigational Site 5

Bethesda, Maryland, United States

Site Status

Investigational Site 15

St Louis, Missouri, United States

Site Status

Investigational Site 30

Bellevue, Nebraska, United States

Site Status

Investigational Site 19

Skillman, New Jersey, United States

Site Status

Investigational Site 18

Corning, New York, United States

Site Status

Investigational Site 7

High Point, North Carolina, United States

Site Status

Investigational Site 21

Raleigh, North Carolina, United States

Site Status

Investigational Site 16

Sylvania, Ohio, United States

Site Status

Investigational Site 22

Pittsburgh, Pennsylvania, United States

Site Status

Investigational Site 13

Spartanburg, South Carolina, United States

Site Status

Investigational Site 23

Austin, Texas, United States

Site Status

Investigational Site 24

Austin, Texas, United States

Site Status

Investigational Site 3

Austin, Texas, United States

Site Status

Investigational Site 31

Dallas, Texas, United States

Site Status

Investigational Site 34

El Paso, Texas, United States

Site Status

Investigational Site 6

Kerrville, Texas, United States

Site Status

Investigational Site 14

New Braunfels, Texas, United States

Site Status

Investigational Site 10

San Antonio, Texas, United States

Site Status

Investigational Site 12

San Antonio, Texas, United States

Site Status

Investigational Site 17

San Antonio, Texas, United States

Site Status

Investigational Site 1

San Antonio, Texas, United States

Site Status

Investigational Site 20

San Antonio, Texas, United States

Site Status

Investigational Site 25

Waco, Texas, United States

Site Status

Investigational Site 8

Waco, Texas, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 31248471 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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GPL/CT/2014/018/III

Identifier Type: -

Identifier Source: org_study_id

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