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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1180

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Glenmark Specialty S.A.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 10, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 13, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 16, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 25, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 28, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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