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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00118703
First received: July 1, 2005
Last updated: July 14, 2017
Last verified: March 2017
  Purpose
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).

Condition Intervention Phase
Vasomotor Rhinitis Rhinitis, Vasomotor Drug: GW685698X Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A 4 Week Randomized, Double Blind, Placebo Controlled Study of GW685698X Aq Nasal Spray 100mcg QD in Adults and Adolescents With Vasomotor Rhinitis

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.

  • 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.


Enrollment: 350
Study Start Date: July 1, 2005
Study Completion Date: February 9, 2006
Primary Completion Date: February 1, 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00118703

  Hide Study Locations
Locations
United States, Alabama
GSK Investigational Site
Birmingham, Alabama, United States, 35209
United States, Arizona
GSK Investigational Site
Phoenix, Arizona, United States, 85012
United States, Arkansas
GSK Investigational Site
Little Rock, Arkansas, United States, 72205
United States, California
GSK Investigational Site
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
United States, Colorado
GSK Investigational Site
Englewood, Colorado, United States, 80112
United States, Florida
GSK Investigational Site
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
United States, Georgia
GSK Investigational Site
Stockbridge, Georgia, United States, 30281
United States, Illinois
GSK Investigational Site
Chicago, Illinois, United States, 60612
GSK Investigational Site
Chicago, Illinois, United States, 60632
United States, Indiana
GSK Investigational Site
South Bend, Indiana, United States, 46617
United States, Louisiana
GSK Investigational Site
Shreveport, Louisiana, United States, 71105
United States, Maryland
GSK Investigational Site
Bethesda, Maryland, United States, 20814
GSK Investigational Site
Wheaton, Maryland, United States, 20902
United States, Massachusetts
GSK Investigational Site
North Dartmouth, Massachusetts, United States, 02747
United States, Michigan
GSK Investigational Site
Detroit, Michigan, United States, 48202
United States, Mississippi
GSK Investigational Site
Jackson, Mississippi, United States, 39202
United States, Missouri
GSK Investigational Site
Saint Louis, Missouri, United States, 63141
United States, New Jersey
GSK Investigational Site
Bricktown, New Jersey, United States, 8724
GSK Investigational Site
Skillman, New Jersey, United States, 08558
United States, New York
GSK Investigational Site
Ithaca, New York, United States, 14850
GSK Investigational Site
Rochester, New York, United States, 14618
United States, Ohio
GSK Investigational Site
Sylvania, Ohio, United States, 43560
United States, Pennsylvania
GSK Investigational Site
Blue Bell, Pennsylvania, United States, 19422
United States, Rhode Island
GSK Investigational Site
Providence, Rhode Island, United States, 2906
United States, Tennessee
GSK Investigational Site
Chattanooga, Tennessee, United States, 37421
United States, Texas
GSK Investigational Site
Dallas, Texas, United States, 75231-4307
GSK Investigational Site
Dallas, Texas, United States, 75231
GSK Investigational Site
San Antonio, Texas, United States, 78229
United States, Vermont
GSK Investigational Site
South Burlington, Vermont, United States, 05403
Canada, Manitoba
GSK Investigational Site
Winnipeg, Manitoba, Canada, R3C 0N2
Canada, Ontario
GSK Investigational Site
Hamilton, Ontario, Canada, L8M 1K7
GSK Investigational Site
Ottawa, Ontario, Canada, K1Y 4G2
Canada, Quebec
GSK Investigational Site
Trois Rivières, Quebec, Canada, G8T 7A1
Czechia
GSK Investigational Site
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
Germany
GSK Investigational Site
Weinheim, Baden-Wuerttemberg, Germany, 69469
GSK Investigational Site
Nuernberg, Bayern, Germany, 90443
GSK Investigational Site
Wiesbaden, Hessen, Germany, 65187
GSK Investigational Site
Berlin, Germany, 12163
GSK Investigational Site
Berlin, Germany, 13125
GSK Investigational Site
Berlin, Germany, 14057
Norway
GSK Investigational Site
Oslo, Norway, N-0264
GSK Investigational Site
Oslo, Norway, N-0594
Puerto Rico
GSK Investigational Site
Ponce, Puerto Rico, 00716
Romania
GSK Investigational Site
Bucharest, Romania, 022102
GSK Investigational Site
Iasi, Romania, 700115
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Additional Information:
Study Data/Documents: Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: FFR30007
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: FFR30007
For additional information about this study please refer to the GSK Clinical Study Register
Annotated Case Report Form  This link exits the ClinicalTrials.gov site
Identifier: FFR30007
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: FFR30007
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: FFR30007
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: FFR30007
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: FFR30007
For additional information about this study please refer to the GSK Clinical Study Register

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00118703     History of Changes
Other Study ID Numbers: FFR30007
Study First Received: July 1, 2005
Results First Received: March 21, 2017
Last Updated: July 14, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
URL: http://

Keywords provided by GlaxoSmithKline:
nonallergic rhinitis
GW685698X
VMR
vasomotor rhinitis

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Vasomotor
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on August 23, 2017