Once-Daily Investigational Nasal Spray In Adults And Adolescents With Vasomotor Rhinitis

July 14, 2017 updated by: GlaxoSmithKline

A 4 Week Randomized, Double Blind, Placebo Controlled Study of GW685698X Aq Nasal Spray 100mcg QD in Adults and Adolescents With Vasomotor Rhinitis

The primary objective of this study is to compare the efficacy and safety of GW685698X 100mcg once daily (QD) aqueous nasal spray with vehicle placebo nasal spray in adult and adolescent subjects (12 years of age and older) with vasomotor rhinitis (VMR).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

350

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

  • Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3C 0N2
        • GSK Investigational Site
    • Ontario
      • Hamilton, Ontario, Canada, L8M 1K7
        • GSK Investigational Site
      • Ottawa, Ontario, Canada, K1Y 4G2
        • GSK Investigational Site
    • Quebec
      • Trois Rivières, Quebec, Canada, G8T 7A1
        • GSK Investigational Site
  • Czechia
      • Brno, Czechia, 656 51
        • GSK Investigational Site
      • Pardubice, Czechia, 532 03
        • GSK Investigational Site
      • Plzen, Czechia, 301 00
        • GSK Investigational Site
      • Praha 5, Czechia, 150 06
        • GSK Investigational Site
  • Germany
      • Berlin, Germany, 14057
        • GSK Investigational Site
      • Berlin, Germany, 13125
        • GSK Investigational Site
      • Berlin, Germany, 12163
        • GSK Investigational Site
    • Baden-Wuerttemberg
      • Weinheim, Baden-Wuerttemberg, Germany, 69469
        • GSK Investigational Site
    • Bayern
      • Nuernberg, Bayern, Germany, 90443
        • GSK Investigational Site
    • Hessen
      • Wiesbaden, Hessen, Germany, 65187
        • GSK Investigational Site
  • Norway
      • Oslo, Norway, N-0264
        • GSK Investigational Site
      • Oslo, Norway, N-0594
        • GSK Investigational Site
  • Puerto Rico
      • Ponce, Puerto Rico, 00716
        • GSK Investigational Site
  • Romania
      • Bucharest, Romania, 022102
        • GSK Investigational Site
      • Iasi, Romania, 700115
        • GSK Investigational Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35209
        • GSK Investigational Site
    • Arizona
      • Phoenix, Arizona, United States, 85012
        • GSK Investigational Site
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • GSK Investigational Site
    • California
      • Fresno, California, United States, 93720
        • GSK Investigational Site
      • Irvine, California, United States, 92618
        • GSK Investigational Site
      • Los Angeles, California, United States, 90025
        • GSK Investigational Site
      • Orange, California, United States, 92868
        • GSK Investigational Site
      • Paramount, California, United States, 90723
        • GSK Investigational Site
      • Sacramento, California, United States, 95819
        • GSK Investigational Site
      • San Francisco, California, United States, 94102
        • GSK Investigational Site
      • San Jose, California, United States, 95128
        • GSK Investigational Site
      • Walnut Creek, California, United States, 94598
        • GSK Investigational Site
    • Colorado
      • Englewood, Colorado, United States, 80112
        • GSK Investigational Site
    • Florida
      • Miami, Florida, United States, 33173
        • GSK Investigational Site
      • Sarasota, Florida, United States, 34233
        • GSK Investigational Site
      • Tallahassee, Florida, United States, 32308
        • GSK Investigational Site
      • Vero Beach, Florida, United States, 32960
        • GSK Investigational Site
    • Georgia
      • Stockbridge, Georgia, United States, 30281
        • GSK Investigational Site
    • Illinois
      • Chicago, Illinois, United States, 60612
        • GSK Investigational Site
      • Chicago, Illinois, United States, 60632
        • GSK Investigational Site
    • Indiana
      • South Bend, Indiana, United States, 46617
        • GSK Investigational Site
    • Louisiana
      • Shreveport, Louisiana, United States, 71105
        • GSK Investigational Site
    • Maryland
      • Bethesda, Maryland, United States, 20814
        • GSK Investigational Site
      • Wheaton, Maryland, United States, 20902
        • GSK Investigational Site
    • Massachusetts
      • North Dartmouth, Massachusetts, United States, 02747
        • GSK Investigational Site
    • Michigan
      • Detroit, Michigan, United States, 48202
        • GSK Investigational Site
    • Mississippi
      • Jackson, Mississippi, United States, 39202
        • GSK Investigational Site
    • Missouri
      • Saint Louis, Missouri, United States, 63141
        • GSK Investigational Site
    • New Jersey
      • Bricktown, New Jersey, United States, 8724
        • GSK Investigational Site
      • Skillman, New Jersey, United States, 08558
        • GSK Investigational Site
    • New York
      • Ithaca, New York, United States, 14850
        • GSK Investigational Site
      • Rochester, New York, United States, 14618
        • GSK Investigational Site
    • Ohio
      • Sylvania, Ohio, United States, 43560
        • GSK Investigational Site
    • Pennsylvania
      • Blue Bell, Pennsylvania, United States, 19422
        • GSK Investigational Site
    • Rhode Island
      • Providence, Rhode Island, United States, 2906
        • GSK Investigational Site
    • Tennessee
      • Chattanooga, Tennessee, United States, 37421
        • GSK Investigational Site
    • Texas
      • Dallas, Texas, United States, 75231
        • GSK Investigational Site
      • Dallas, Texas, United States, 75231-4307
        • GSK Investigational Site
      • San Antonio, Texas, United States, 78229
        • GSK Investigational Site
    • Vermont
      • South Burlington, Vermont, United States, 05403
        • GSK Investigational Site

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:

  • Must be outpatients.
  • Diagnosis of VMR (vasomotor rhinitis).
  • Literate in English or native language.

Exclusion criteria:

  • Significant concomitant medical condition.
  • Use corticosteroids or other allergy medications during the study.
  • Used tobacco products within the past year.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Change From Baseline in Daily Reflective Total Nasal Symptom Scores (rTNSS)
Time Frame: Baseline and up to Week 4
The TNSS was the sum of the individual symptom scores for rhinorrhoea, nasal congestion and post-nasal drip which was scored on a scale of 0-3 (total score 0-9). The severity of symptoms was defined as 0: none-symptom was not present, 1: mild-sign/symptom was clearly present but minimal awareness; easily tolerated, 2: moderate-definite awareness of sign/symptom that was bothersome but tolerable, 3: severe (sign/symptom was hard to tolerate; causes interference with activities of daily living and/or sleeping. The rTNSS was a rating of the severity of symptoms over the previous 12 hours and was performed in the morning (AM rTNSS) and evening (post meridian [PM] rTNSS). The daily rTNSS was the sum of two assessments. The Baseline daily rTNSS was defined as the average of the daily rTNSS over the 4 consecutive 24-hour periods prior to randomization, including the assessment on the morning of randomization. Change from Baseline was calculated as the on-treatment value minus the Baseline.
Baseline and up to Week 4

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Change From Baseline in Morning (AM) Pre-dose Instantaneous Total Nasal Symptom Scores (iTNSS)
Time Frame: Baseline and up to Week 4
The morning pre-dose iTNSS was the sum of the individual symptom score for rhinorrhoea, nasal congestion and postnasal drip performed immediately prior to taking the daily dose which were scored on a scale of 0-3 (total score 0-9). The severity of symptoms was defined as 0: none-symptom was not present, 1: mild-sign/symptom was clearly present but minimal awareness; easily tolerated, 2: moderate-definite awareness of sign/symptom that was bothersome but tolerable, 3: severe (sign/symptom was hard to tolerate; causes interference with activities of daily living and/or sleeping. The Baseline daily iTNSS was defined as the average of the daily iTNSS over the 4 consecutive 24-hour periods prior to randomization, including the assessment on the morning of randomization. Change from Baseline was calculated as the on-treatment value minus the Baseline value.
Baseline and up to Week 4
Number of Participants Based on Overall Evaluation of Response to Therapy
Time Frame: Week 4 (Day 29) or Early Withdrawal
Participants were evaluated effectiveness of study medication for relieving non-allergic rhinitis symptoms over the entire treatment period. The overall evaluation of response to therapy was based on a 7-point categorical scale (1-7) where the participants rate their perception of the change or lack of change in their VMR symptoms at the end of the study. The 7 categories were: 1: significantly improved, 2: moderately improved, 3: mildly improved, 4: no change, 5: mildly worse, 6: moderately worse and 7: significantly worse. Effectiveness of study medication for relieving VMR symptoms over the entire treatment period.
Week 4 (Day 29) or Early Withdrawal

Collaborators and Investigators

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

Sponsor

GlaxoSmithKline

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.

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

July 1, 2005

Primary Completion (Actual)

February 1, 2006

Study Completion (Actual)

February 9, 2006

Study Registration Dates

First Submitted

July 1, 2005

First Submitted That Met QC Criteria

July 1, 2005

First Posted (Estimate)

July 12, 2005

Study Record Updates

Last Update Posted (Actual)

August 21, 2017

Last Update Submitted That Met QC Criteria

July 14, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FFR30007

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Study Data/Documents

  1. Dataset Specification
    Information identifier: FFR30007
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  2. Clinical Study Report
    Information identifier: FFR30007
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  3. Annotated Case Report Form
    Information identifier: FFR30007
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  4. Informed Consent Form
    Information identifier: FFR30007
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  5. Individual Participant Data Set
    Information identifier: FFR30007
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  6. Study Protocol
    Information identifier: FFR30007
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  7. Statistical Analysis Plan
    Information identifier: FFR30007
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register

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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