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

Primary Purpose

Vasomotor Rhinitis, Rhinitis, Vasomotor

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
GW685698X
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vasomotor Rhinitis focused on measuring nonallergic rhinitis, GW685698X, VMR, vasomotor rhinitis

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site

Outcomes

Primary Outcome Measures

Mean Change From Baseline in Daily Reflective Total Nasal Symptom Scores (rTNSS)
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)
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
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.

Full Information

First Posted
July 1, 2005
Last Updated
July 14, 2017
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00118703
Brief Title
Once-Daily Investigational Nasal Spray In Adults And Adolescents With Vasomotor Rhinitis
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
July 1, 2005 (undefined)
Primary Completion Date
February 1, 2006 (Actual)
Study Completion Date
February 9, 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline

4. Oversight

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vasomotor Rhinitis, Rhinitis, Vasomotor
Keywords
nonallergic rhinitis, GW685698X, VMR, vasomotor rhinitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
350 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
GW685698X
Primary Outcome Measure Information:
Title
Mean Change From Baseline in Daily Reflective Total Nasal Symptom Scores (rTNSS)
Description
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.
Time Frame
Baseline and up to Week 4
Secondary Outcome Measure Information:
Title
Mean Change From Baseline in Morning (AM) Pre-dose Instantaneous Total Nasal Symptom Scores (iTNSS)
Description
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.
Time Frame
Baseline and up to Week 4
Title
Number of Participants Based on Overall Evaluation of Response to Therapy
Description
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.
Time Frame
Week 4 (Day 29) or Early Withdrawal

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Facility Name
GSK Investigational Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85012
Country
United States
Facility Name
GSK Investigational Site
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
GSK Investigational Site
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
GSK Investigational Site
City
Irvine
State/Province
California
ZIP/Postal Code
92618
Country
United States
Facility Name
GSK Investigational Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90025
Country
United States
Facility Name
GSK Investigational Site
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
GSK Investigational Site
City
Paramount
State/Province
California
ZIP/Postal Code
90723
Country
United States
Facility Name
GSK Investigational Site
City
Sacramento
State/Province
California
ZIP/Postal Code
95819
Country
United States
Facility Name
GSK Investigational Site
City
San Francisco
State/Province
California
ZIP/Postal Code
94102
Country
United States
Facility Name
GSK Investigational Site
City
San Jose
State/Province
California
ZIP/Postal Code
95128
Country
United States
Facility Name
GSK Investigational Site
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Facility Name
GSK Investigational Site
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80112
Country
United States
Facility Name
GSK Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
Facility Name
GSK Investigational Site
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34233
Country
United States
Facility Name
GSK Investigational Site
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
Facility Name
GSK Investigational Site
City
Vero Beach
State/Province
Florida
ZIP/Postal Code
32960
Country
United States
Facility Name
GSK Investigational Site
City
Stockbridge
State/Province
Georgia
ZIP/Postal Code
30281
Country
United States
Facility Name
GSK Investigational Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
GSK Investigational Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60632
Country
United States
Facility Name
GSK Investigational Site
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46617
Country
United States
Facility Name
GSK Investigational Site
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71105
Country
United States
Facility Name
GSK Investigational Site
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20814
Country
United States
Facility Name
GSK Investigational Site
City
Wheaton
State/Province
Maryland
ZIP/Postal Code
20902
Country
United States
Facility Name
GSK Investigational Site
City
North Dartmouth
State/Province
Massachusetts
ZIP/Postal Code
02747
Country
United States
Facility Name
GSK Investigational Site
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
GSK Investigational Site
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39202
Country
United States
Facility Name
GSK Investigational Site
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
GSK Investigational Site
City
Bricktown
State/Province
New Jersey
ZIP/Postal Code
8724
Country
United States
Facility Name
GSK Investigational Site
City
Skillman
State/Province
New Jersey
ZIP/Postal Code
08558
Country
United States
Facility Name
GSK Investigational Site
City
Ithaca
State/Province
New York
ZIP/Postal Code
14850
Country
United States
Facility Name
GSK Investigational Site
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
Country
United States
Facility Name
GSK Investigational Site
City
Sylvania
State/Province
Ohio
ZIP/Postal Code
43560
Country
United States
Facility Name
GSK Investigational Site
City
Blue Bell
State/Province
Pennsylvania
ZIP/Postal Code
19422
Country
United States
Facility Name
GSK Investigational Site
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
2906
Country
United States
Facility Name
GSK Investigational Site
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37421
Country
United States
Facility Name
GSK Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231-4307
Country
United States
Facility Name
GSK Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
GSK Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
GSK Investigational Site
City
South Burlington
State/Province
Vermont
ZIP/Postal Code
05403
Country
United States
Facility Name
GSK Investigational Site
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3C 0N2
Country
Canada
Facility Name
GSK Investigational Site
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8M 1K7
Country
Canada
Facility Name
GSK Investigational Site
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y 4G2
Country
Canada
Facility Name
GSK Investigational Site
City
Trois Rivières
State/Province
Quebec
ZIP/Postal Code
G8T 7A1
Country
Canada
Facility Name
GSK Investigational Site
City
Brno
ZIP/Postal Code
656 51
Country
Czechia
Facility Name
GSK Investigational Site
City
Pardubice
ZIP/Postal Code
532 03
Country
Czechia
Facility Name
GSK Investigational Site
City
Plzen
ZIP/Postal Code
301 00
Country
Czechia
Facility Name
GSK Investigational Site
City
Praha 5
ZIP/Postal Code
150 06
Country
Czechia
Facility Name
GSK Investigational Site
City
Weinheim
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
69469
Country
Germany
Facility Name
GSK Investigational Site
City
Nuernberg
State/Province
Bayern
ZIP/Postal Code
90443
Country
Germany
Facility Name
GSK Investigational Site
City
Wiesbaden
State/Province
Hessen
ZIP/Postal Code
65187
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
12163
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
13125
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
14057
Country
Germany
Facility Name
GSK Investigational Site
City
Oslo
ZIP/Postal Code
N-0264
Country
Norway
Facility Name
GSK Investigational Site
City
Oslo
ZIP/Postal Code
N-0594
Country
Norway
Facility Name
GSK Investigational Site
City
Ponce
ZIP/Postal Code
00716
Country
Puerto Rico
Facility Name
GSK Investigational Site
City
Bucharest
ZIP/Postal Code
022102
Country
Romania
Facility Name
GSK Investigational Site
City
Iasi
ZIP/Postal Code
700115
Country
Romania

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Links:
URL
https://www.clinicalstudydatarequest.com
Description
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
Available IPD and Supporting Information:
Available IPD/Information Type
Dataset Specification
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
FFR30007
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Clinical Study Report
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
FFR30007
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Annotated Case Report Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
FFR30007
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Informed Consent Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
FFR30007
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Individual Participant Data Set
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
FFR30007
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
FFR30007
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Statistical Analysis Plan
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
FFR30007
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register

Learn more about this trial

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

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