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

NCT ID: NCT02631551

Last Updated: 2018-09-25

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2016-07-31

Brief Summary

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Study to evaluate the efficacy and safety of GSP 301 NS compared to placebo NS and to individual monotherapies (comparators) as well as the efficacy of these monotherapies (comparators) versus placebo NS over 14 days of study treatment

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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)

NCT02709538

Perennial Allergic Rhinitis
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Efficacy and Safety of Fixed Dose Combination (FDC) of Olopatadine Hydrochloride and Mometasone Furoate Nasal Spray (Molo; Also Referred as GSP 301) in the Treatment of Seasonal Allergic Rhinitis (SAR)

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Detailed Description

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Conditions

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Seasonal 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 sprays in each nostril twice daily for 14 days

Olopatadine HCl NS

Group Type ACTIVE_COMPARATOR

Olopatadine HCl NS

Intervention Type DRUG

2 sprays in each nostril twice daily for 14 days

Mometasone furoate NS

Group Type ACTIVE_COMPARATOR

Mometasone furoate NS

Intervention Type DRUG

2 sprays in each nostril twice daily for 14 days

GSP 301 Placebo NS

Group Type PLACEBO_COMPARATOR

GSP 301 Placebo NS

Intervention Type DRUG

2 sprays in each nostril twice daily for 14 days

Interventions

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GSP 301 NS

FDC of olopatadine HCl and mometasone furoate: 2 sprays in each nostril twice daily for 14 days

Intervention Type DRUG

Olopatadine HCl NS

2 sprays in each nostril twice daily for 14 days

Intervention Type DRUG

Mometasone furoate NS

2 sprays in each nostril twice daily for 14 days

Intervention Type DRUG

GSP 301 Placebo NS

2 sprays in each nostril twice daily for 14 days

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 SAR (for at least 2 years preceding the Screening Visit \[Visit 1\]) with exacerbations (clinical evidence of active symptoms) during the spring allergy season (tree/grass 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

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

Role: STUDY_DIRECTOR

Glenmark Pharmaceuticals

Locations

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Investigational Site 20

Mission Viejo, California, United States

Site Status

Investigational Site 31

San Diego, California, United States

Site Status

Investigational Site 29

San Jose, California, United States

Site Status

Investigational Site 25

Centennial, Colorado, United States

Site Status

Investigational Site 22

Colorado Springs, Colorado, United States

Site Status

Investigational Site 10

Jupiter, Florida, United States

Site Status

Investigational Site 30

Miami, Florida, United States

Site Status

Investigational Site 37

Marietta, Georgia, United States

Site Status

Investigational Site 15

Stockbridge, Georgia, United States

Site Status

Investigational Site 23

Stockbridge, Georgia, United States

Site Status

Investigational Site 11

Louisville, Kentucky, United States

Site Status

Investigational Site 14

Baltimore, Maryland, United States

Site Status

Investigational Site 33

Wheaton, Maryland, United States

Site Status

Investigational Site 26

Ypsilanti, Michigan, United States

Site Status

Investigational Site 19

Minneapolis, Minnesota, United States

Site Status

Investigational Site 21

St Louis, Missouri, United States

Site Status

Investigational Site 16

Bellevue, Nebraska, United States

Site Status

Investigational Site 12

Skillman, New Jersey, United States

Site Status

Investigational Site 36

Rochester, New York, United States

Site Status

Investigational Site 18

Raleigh, North Carolina, United States

Site Status

Investigational Site 27

Cincinnati, Ohio, United States

Site Status

Investigational Site 34

Middleburg Heights, Ohio, United States

Site Status

Investigational Site 32

Medford, Oregon, United States

Site Status

Investigational Site 35

Portland, Oregon, United States

Site Status

Investigational Site 13

Orangeburg, South Carolina, United States

Site Status

Investigational Site 17

Spartanburg, South Carolina, United States

Site Status

Investigational Site 3

Austin, Texas, United States

Site Status

Investigational Site 5

Austin, Texas, United States

Site Status

Investigational Site 8

Austin, Texas, United States

Site Status

Investigational Site 1

Kerrville, Texas, United States

Site Status

Investigational Site 7

New Braunfels, Texas, United States

Site Status

Investigational Site 2

San Antonio, Texas, United States

Site Status

Investigational Site 4

San Antonio, Texas, United States

Site Status

Investigational Site 6

San Antonio, Texas, United States

Site Status

Investigational Site 9

San Antonio, Texas, United States

Site Status

Investigational Site 28

Waco, Texas, United States

Site Status

Investigational Site 24

Draper, Utah, United States

Site Status

Countries

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United States

References

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Hampel FC, Pedinoff AJ, Jacobs RL, Caracta CF, Tantry SK. Olopatadine-mometasone combination nasal spray: Evaluation of efficacy and safety in patients with seasonal allergic rhinitis. Allergy Asthma Proc. 2019 Jul 3;40(4):261-272. doi: 10.2500/aap.2019.40.4223. Epub 2019 May 3.

Reference Type DERIVED
PMID: 31053180 (View on PubMed)

Other Identifiers

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GPL/CT/2014/016/III

Identifier Type: -

Identifier Source: org_study_id

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