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

August 28, 2018 updated by: Glenmark Specialty S.A.

A Double-Blind, Randomized, Parallel-Group, Comparative Study to Evaluate the Efficacy, Safety and Tolerability of a Fixed Dose Combination GSP 301 Nasal Spray (NS) Compared With Placebo Nasal Spray and Individual Monotherapy Formulations (Comparators) in Subjects (Aged 12 Years and Older) With Seasonal Allergic Rhinitis (SAR)

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1180

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
    • California
      • Mission Viejo, California, United States
        • Investigational site 20
      • San Diego, California, United States
        • Investigational site 31
      • San Jose, California, United States
        • Investigational site 29
    • Colorado
      • Centennial, Colorado, United States
        • Investigational site 25
      • Colorado Springs, Colorado, United States
        • Investigational site 22
    • Florida
      • Jupiter, Florida, United States
        • Investigational site 10
      • Miami, Florida, United States
        • Investigational site 30
    • Georgia
      • Marietta, Georgia, United States
        • Investigational site 37
      • Stockbridge, Georgia, United States
        • Investigational site 15
      • Stockbridge, Georgia, United States
        • Investigational site 23
    • Kentucky
      • Louisville, Kentucky, United States
        • Investigational site 11
    • Maryland
      • Baltimore, Maryland, United States
        • Investigational site 14
      • Wheaton, Maryland, United States
        • Investigational site 33
    • Michigan
      • Ypsilanti, Michigan, United States
        • Investigational site 26
    • Minnesota
      • Minneapolis, Minnesota, United States
        • Investigational site 19
    • Missouri
      • Saint Louis, Missouri, United States
        • Investigational site 21
    • Nebraska
      • Bellevue, Nebraska, United States
        • Investigational Site 16
    • New Jersey
      • Skillman, New Jersey, United States
        • Investigational site 12
    • New York
      • Rochester, New York, United States
        • Investigational site 36
    • North Carolina
      • Raleigh, North Carolina, United States
        • Investigational site 18
    • Ohio
      • Cincinnati, Ohio, United States
        • Investigational site 27
      • Middleburg Heights, Ohio, United States
        • Investigational site 34
    • Oregon
      • Medford, Oregon, United States
        • Investigational site 32
      • Portland, Oregon, United States
        • Investigational site 35
    • South Carolina
      • Orangeburg, South Carolina, United States
        • Investigational site 13
      • Spartanburg, South Carolina, United States
        • Investigational site 17
    • Texas
      • Austin, Texas, United States
        • Investigational site 3
      • Austin, Texas, United States
        • Investigational site 5
      • Austin, Texas, United States
        • Investigational site 8
      • Kerrville, Texas, United States
        • Investigational site 1
      • New Braunfels, Texas, United States
        • Investigational site 7
      • San Antonio, Texas, United States
        • Investigational site 2
      • San Antonio, Texas, United States
        • Investigational site 4
      • San Antonio, Texas, United States
        • Investigational site 6
      • San Antonio, Texas, United States
        • Investigational site 9
      • Waco, Texas, United States
        • Investigational site 28
    • Utah
      • Draper, Utah, United States
        • Investigational site 24

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

12 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 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

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 sprays in each nostril twice daily for 14 days
Placebo Comparator: GSP 301 Placebo NS
Drug: GSP 301 Placebo NS
2 sprays in each nostril twice daily for 14 days
Active Comparator: Olopatadine HCl NS
Drug: Olopatadine HCl NS
2 sprays in each nostril twice daily for 14 days
Active Comparator: Mometasone furoate NS
Drug: Mometasone furoate NS
2 sprays in each nostril twice daily for 14 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Average AM and PM Subject-reported 12-hour Reflective Total Nasal Symptoms Score (rTNSS) From Baseline to End of Treatment.
Time Frame: 14 days
Reflective Total Nasal Symptom Score (rTNSS) was calculated as the sum of 12-hour reflective scoring of the severity of four nasal symptoms (nasal congestion, rhinorrhea, nasal itching, sneezing). Subjects responded on a 4-point severity scale with scores ranging from 0 (no signs/symptoms evident) to 3 (severe signs/symptoms that is hard to tolerate). The rTNSS was calculated as the sum of the subject-reported severity scores for nasal symptoms, and value ranged from 0 (no signs/symptoms evident) to 12 (severe signs/symptoms that is hard to tolerate).
14 days

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, PhD, 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

Helpful Links

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

March 1, 2016

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

December 10, 2015

First Submitted That Met QC Criteria

December 13, 2015

First Posted (Estimate)

December 16, 2015

Study Record Updates

Last Update Posted (Actual)

September 25, 2018

Last Update Submitted That Met QC Criteria

August 28, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GPL/CT/2014/016/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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