NCT00117325

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).

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
352

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jul 2005

Shorter than P25 for phase_3

Geographic Reach
6 countries

53 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 30, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 6, 2005

Completed
5 days until next milestone

Study Start

First participant enrolled

July 11, 2005

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 9, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 9, 2006

Completed
12.1 years until next milestone

Results Posted

Study results publicly available

March 13, 2018

Completed
Last Updated

March 13, 2018

Status Verified

August 1, 2017

Enrollment Period

7 months

First QC Date

June 30, 2005

Results QC Date

August 11, 2017

Last Update Submit

March 7, 2018

Conditions

Rhinitis, Vasomotor

Keywords

Vasomotor RhinitisVMRnonallergic rhinitisGW685698X

Outcome Measures

Primary Outcomes (1)

  • Mean Change From Baseline Over the Entire Treatment Period in Daily Reflective Total Nasal Symptom Score (rTNSS)

    The daily rTNSS was the average of the AM (morning) and PM (before bed time) rTNSS assessments. Each rTNSS assessment comprised the sum of the three nasal symptom scores for rhinorrhea, nasal congestion and postnasal drip where each symptom was scored on a scale of 0 (no symptoms) to 3 (severe symptoms).. 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. Change from Baseline was calculated as any post-Baseline value minus the Baseline value. Baseline visit was 4 days prior to randomization (Day 1).

    Baseline (4 days prior to randomization [Day 1]) and up to Week 4

Secondary Outcomes (11)

  • Mean Change From Baseline Over the Entire Treatment Period in Morning (AM), Pre-dose, Instantaneous Total Nasal Symptom Scores (iTNSS)

    Baseline (4 days prior to randomization [Day 1]) and up to Week 4

  • Number of Participants With Overall Evaluation of Response to Therapy

    Up to 4 weeks

  • Mean Change From Baseline Over the Entire Treatment Period in AM Pre-dose rTNSS

    Baseline (4 days prior to randomization [Day 1]) and up to Week 4

  • Mean Change From Baseline Over the Entire Treatment Period in Evening (PM) rTNSS

    Baseline (4 days prior to randomization [Day 1]) and up to Week 4

  • Mean Percent Change From Baseline Over the Entire Treatment Period in Daily rTNSS

    Baseline (4 days prior to randomization [Day 1]) and up to Week 4

  • +6 more secondary outcomes

Study Arms (1)

GW685698X

EXPERIMENTAL

GW685698X

Drug: GW685698X

Interventions

GW685698XDRUG

Aqueous Nasal Spray 100mcg

GW685698X

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Must be outpatients.
  • Diagnosis of VMR.
  • Literate in English or native language.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (53)

GSK Investigational Site

Beverly Hills, California, 90212, United States

Location

GSK Investigational Site

Huntington Beach, California, 92647, United States

Location

GSK Investigational Site

Mission Viejo, California, 92691, United States

Location

GSK Investigational Site

San Diego, California, 92120, United States

Location

GSK Investigational Site

San Diego, California, 92123, United States

Location

GSK Investigational Site

Santa Barbara, California, 93105, United States

Location

GSK Investigational Site

Colorado Springs, Colorado, 80907, United States

Location

GSK Investigational Site

Englewood, Colorado, 80112, United States

Location

GSK Investigational Site

Fort Collins, Colorado, 80526, United States

Location

GSK Investigational Site

Woodstock, Georgia, 30188, United States

Location

GSK Investigational Site

Chicago, Illinois, 60637, United States

Location

GSK Investigational Site

Evansville, Indiana, 47713, United States

Location

GSK Investigational Site

Louisville, Kentucky, 40207, United States

Location

GSK Investigational Site

Covington, Louisiana, 70433, United States

Location

GSK Investigational Site

Shreveport, Louisiana, 71104, United States

Location

GSK Investigational Site

Bangor, Maine, 04401, United States

Location

GSK Investigational Site

Baltimore, Maryland, 21236, United States

Location

GSK Investigational Site

Rockville, Maryland, 20850, United States

Location

GSK Investigational Site

Novi, Michigan, 48375, United States

Location

GSK Investigational Site

Ypsilanti, Michigan, 48197, United States

Location

GSK Investigational Site

Minneapolis, Minnesota, 55402, United States

Location

GSK Investigational Site

Mount Laurel, New Jersey, 08054, United States

Location

GSK Investigational Site

Liverpool, New York, 13088, United States

Location

GSK Investigational Site

Rochester, New York, 14618, United States

Location

GSK Investigational Site

Canton, Ohio, 44718, United States

Location

GSK Investigational Site

Cincinnati, Ohio, 45231, United States

Location

GSK Investigational Site

North Olmsted, Ohio, 44070, United States

Location

GSK Investigational Site

Lake Oswego, Oregon, 97035, United States

Location

GSK Investigational Site

Portland, Oregon, 97213, United States

Location

GSK Investigational Site

Easton, Pennsylvania, 18042, United States

Location

GSK Investigational Site

Palmyra, Pennsylvania, 17078, United States

Location

GSK Investigational Site

Pittsburgh, Pennsylvania, 15213, United States

Location

GSK Investigational Site

Upland, Pennsylvania, 19013, United States

Location

GSK Investigational Site

Charleston, South Carolina, 29407, United States

Location

GSK Investigational Site

Orangeburg, South Carolina, 29118, United States

Location

GSK Investigational Site

Germantown, Tennessee, 38138, United States

Location

GSK Investigational Site

Knoxville, Tennessee, 37922, United States

Location

GSK Investigational Site

Salt Lake City, Utah, 84102, United States

Location

GSK Investigational Site

Kelowna, British Columbia, V1Y 9L8, Canada

Location

GSK Investigational Site

Hamilton, Ontario, L8N 3Z5, Canada

Location

GSK Investigational Site

Québec, G1V 4M6, Canada

Location

GSK Investigational Site

Litoměřice, 412 01, Czechia

Location

GSK Investigational Site

Olomouc, 775 25, Czechia

Location

GSK Investigational Site

Tábor, 390 19, Czechia

Location

GSK Investigational Site

Kassel, Hesse, 34117, Germany

Location

GSK Investigational Site

Hanover, Lower Saxony, 30159, Germany

Location

GSK Investigational Site

Schwerin, Mecklenburg-Vorpommern, 19055, Germany

Location

GSK Investigational Site

Geesthacht, Schleswig-Holstein, 21502, Germany

Location

GSK Investigational Site

Hamburg, 20249, Germany

Location

GSK Investigational Site

Larvik, N-3256, Norway

Location

GSK Investigational Site

Nesttun, N-5227, Norway

Location

GSK Investigational Site

Bucharest, Romania

Location

GSK Investigational Site

Deva, 2700, Romania

Location

Related Links

MeSH Terms

Conditions

Rhinitis, Vasomotor

Condition Hierarchy (Ancestors)

RhinitisNose DiseasesRespiratory Tract DiseasesOtorhinolaryngologic Diseases

Results Point of Contact

Title
GSK Response Center
Organization
GlaxoSmithKline
866-435-7343

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 30, 2005

First Posted

July 6, 2005

Study Start

July 11, 2005

Primary Completion

February 9, 2006

Study Completion

February 9, 2006

Last Updated

March 13, 2018

Results First Posted

March 13, 2018

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will share

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

Available IPD Datasets

Clinical Study Report (FFR30006)Access
Statistical Analysis Plan (FFR30006)Access
Dataset Specification (FFR30006)Access
Study Protocol (FFR30006)Access
Individual Participant Data Set (FFR30006)Access
Informed Consent Form (FFR30006)Access
Annotated Case Report Form (FFR30006)Access

Locations

CA(3)DE(5)US(38)NO(2)RO(2)CZ(3)