Long Term Safety and Efficacy of Fixed Dose Combination GSP 301 Nasal Spray (NS) in the Treatment of Perennial Allergic Rhinitis (PAR) (GSP 301-303)

February 12, 2020 updated by: Glenmark Specialty S.A.

A Double-Blind, Randomized, Parallel-Group Study to Evaluate Long-Term Safety, Tolerability, and Efficacy of a Fixed Dose Combination GSP 301 Nasal Spray Compared With Two Placebo Nasal Spray Formulations in Subjects (Aged 12 Years and Older) With Perennial Allergic Rhinitis (PAR)

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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

601

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • Hot Springs, Arkansas, United States
        • Investigational Site 2
    • California
      • Encinitas, California, United States
        • Investigational site 28
      • San Diego, California, United States
        • Investigational site 27
      • San Diego, California, United States
        • Investigational site 29
    • Colorado
      • Denver, Colorado, United States
        • Investigational site 32
    • Florida
      • Aventura, Florida, United States
        • Investigational site 26
      • Miami, Florida, United States
        • Investigational Site 9
      • Tallahassee, Florida, United States
        • Investigational site 33
    • Georgia
      • Stockbridge, Georgia, United States
        • Investigational site 11
    • Kentucky
      • Louisville, Kentucky, United States
        • Investigational Site 4
    • Maryland
      • Bethesda, Maryland, United States
        • Investigational Site 5
    • Missouri
      • Saint Louis, Missouri, United States
        • Investigational site 15
    • Nebraska
      • Bellevue, Nebraska, United States
        • Investigational site 30
    • New Jersey
      • Skillman, New Jersey, United States
        • Investigational site 19
    • New York
      • Corning, New York, United States
        • Investigational site 18
    • North Carolina
      • High Point, North Carolina, United States
        • Investigational Site 7
      • Raleigh, North Carolina, United States
        • Investigational site 21
    • Ohio
      • Sylvania, Ohio, United States
        • Investigational site 16
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States
        • Investigational site 22
    • South Carolina
      • Spartanburg, South Carolina, United States
        • Investigational site 13
    • Texas
      • Austin, Texas, United States
        • Investigational site 23
      • Austin, Texas, United States
        • Investigational site 24
      • Austin, Texas, United States
        • Investigational Site 3
      • Dallas, Texas, United States
        • Investigational site 31
      • El Paso, Texas, United States
        • Investigational site 34
      • Kerrville, Texas, United States
        • Investigational Site 6
      • New Braunfels, Texas, United States
        • Investigational site 14
      • San Antonio, Texas, United States
        • Investigational site 10
      • San Antonio, Texas, United States
        • Investigational site 12
      • San Antonio, Texas, United States
        • Investigational site 17
      • San Antonio, Texas, United States
        • Investigational Site 1
      • San Antonio, Texas, United States
        • Investigational site 20
      • Waco, Texas, United States
        • Investigational site 25
      • Waco, Texas, United States
        • Investigational Site 8

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: GSP 301 NS
Drug: GSP 301 NS
FDC of olopatadine HCl and mometasone furoate: 2 spray in each nostril twice daily for 52 weeks
Placebo Comparator: GSP 301 Placebo NS pH 3.7
Drug: GSP 301 Placebo NS pH 3.7
2 spray in each nostril twice daily for 52 weeks
Placebo Comparator: GSP 301 Placebo NS pH 7.0
Drug: GSP 301 Placebo NS pH 7.0
2 spray in each nostril twice daily for 52 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Treatment-emergent Adverse Events (TEAEs).
Time Frame: 52 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Glenmark Specialty S.A.

Investigators

  • Study Director: Sudeesh Tantry, Glenmark Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (Actual)

July 1, 2017

Study Completion (Actual)

July 1, 2017

Study Registration Dates

First Submitted

March 11, 2016

First Submitted That Met QC Criteria

March 15, 2016

First Posted (Estimate)

March 16, 2016

Study Record Updates

Last Update Posted (Actual)

February 26, 2020

Last Update Submitted That Met QC Criteria

February 12, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GPL/CT/2014/018/III

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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