NCT02709538

Brief Summary

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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
601

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Apr 2016

Shorter than P25 for phase_3

Geographic Reach
1 country

34 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 11, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 16, 2016

Completed
16 days until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

September 13, 2018

Completed
Last Updated

February 26, 2020

Status Verified

February 1, 2020

Enrollment Period

1.2 years

First QC Date

March 11, 2016

Results QC Date

July 23, 2018

Last Update Submit

February 12, 2020

Conditions

Perennial Allergic Rhinitis

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Treatment-emergent Adverse Events (TEAEs).

    All TEAEs and serious adverse events (SAEs) occurring in the study, in terms of nature, onset, duration, severity, relationship, and outcome were reported.

    52 weeks

Study Arms (3)

GSP 301 NS

EXPERIMENTAL
Drug: GSP 301 NS

GSP 301 Placebo NS pH 3.7

PLACEBO COMPARATOR
Drug: GSP 301 Placebo NS pH 3.7

GSP 301 Placebo NS pH 7.0

PLACEBO COMPARATOR
Drug: GSP 301 Placebo NS pH 7.0

Interventions

GSP 301 NSDRUG

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

GSP 301 NS
GSP 301 Placebo NS pH 3.7DRUG

2 spray in each nostril twice daily for 52 weeks

GSP 301 Placebo NS pH 3.7
GSP 301 Placebo NS pH 7.0DRUG

2 spray in each nostril twice daily for 52 weeks

GSP 301 Placebo NS pH 7.0

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Aged ≥12 years and older inclusive of either sex.
  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (34)

Investigational Site 2

Hot Springs, Arkansas, United States

Location

Investigational Site 28

Encinitas, California, United States

Location

Investigational Site 27

San Diego, California, United States

Location

Investigational Site 29

San Diego, California, United States

Location

Investigational Site 32

Denver, Colorado, United States

Location

Investigational Site 26

Aventura, Florida, United States

Location

Investigational Site 9

Miami, Florida, United States

Location

Investigational Site 33

Tallahassee, Florida, United States

Location

Investigational Site 11

Stockbridge, Georgia, United States

Location

Investigational Site 4

Louisville, Kentucky, United States

Location

Investigational Site 5

Bethesda, Maryland, United States

Location

Investigational Site 15

St Louis, Missouri, United States

Location

Investigational Site 30

Bellevue, Nebraska, United States

Location

Investigational Site 19

Skillman, New Jersey, United States

Location

Investigational Site 18

Corning, New York, United States

Location

Investigational Site 7

High Point, North Carolina, United States

Location

Investigational Site 21

Raleigh, North Carolina, United States

Location

Investigational Site 16

Sylvania, Ohio, United States

Location

Investigational Site 22

Pittsburgh, Pennsylvania, United States

Location

Investigational Site 13

Spartanburg, South Carolina, United States

Location

Investigational Site 23

Austin, Texas, United States

Location

Investigational Site 24

Austin, Texas, United States

Location

Investigational Site 3

Austin, Texas, United States

Location

Investigational Site 31

Dallas, Texas, United States

Location

Investigational Site 34

El Paso, Texas, United States

Location

Investigational Site 6

Kerrville, Texas, United States

Location

Investigational Site 14

New Braunfels, Texas, United States

Location

Investigational Site 10

San Antonio, Texas, United States

Location

Investigational Site 12

San Antonio, Texas, United States

Location

Investigational Site 17

San Antonio, Texas, United States

Location

Investigational Site 1

San Antonio, Texas, United States

Location

Investigational Site 20

San Antonio, Texas, United States

Location

Investigational Site 25

Waco, Texas, United States

Location

Investigational Site 8

Waco, Texas, United States

Location

Related Publications (1)

  • 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.

    PMID: 31248471DERIVED

MeSH Terms

Conditions

Rhinitis, Allergic, Perennial

Condition Hierarchy (Ancestors)

Rhinitis, AllergicRhinitisNose DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityOtorhinolaryngologic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Results Point of Contact

Title
Study Director
Organization
Glenmark Pharmaceuticals Ltd.
clinicaltrialsdisclosuredesk@glenmarkpharma.com
201-684 8000

Study Officials

  • Sudeesh Tantry

    Glenmark Pharmaceuticals

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2016

First Posted

March 16, 2016

Study Start

April 1, 2016

Primary Completion

July 1, 2017

Study Completion

July 1, 2017

Last Updated

February 26, 2020

Results First Posted

September 13, 2018

Record last verified: 2020-02

Locations

US(34)