Clinical trial NCT00118703: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Vasomotor Rhinitis
Rhinitis, Vasomotor
Keywords: nonallergic rhinitis
GW685698X
VMR
vasomotor rhinitis
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2005-07-12
Enrollment: 350
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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.

Primary outcomes:
measure: Mean Change From Baseline in Daily Reflective Total Nasal Symptom Scores (rTNSS)
timeFrame: Baseline and up to Week 4
Secondary outcomes:
measure: Mean Change From Baseline in Morning (AM) Pre-dose Instantaneous Total Nasal Symptom Scores (iTNSS)
timeFrame: Baseline and up to Week 4
measure: Number of Participants Based on Overall Evaluation of Response to Therapy
timeFrame: Week 4 (Day 29) or Early Withdrawal
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: GSK Investigational Site
state: Alabama
city: Phoenix
country: United States
facility: GSK Investigational Site
state: Arizona
city: Little Rock
country: United States
facility: GSK Investigational Site
state: Arkansas
city: Fresno
country: United States
facility: GSK Investigational Site
state: California
city: Irvine
country: United States
facility: GSK Investigational Site
state: California
city: Los Angeles
country: United States
facility: GSK Investigational Site
state: California
city: Orange
country: United States
facility: GSK Investigational Site
state: California
city: Paramount
country: United States
facility: GSK Investigational Site
state: California
city: Sacramento
country: United States
facility: GSK Investigational Site
state: California
city: San Francisco
country: United States
facility: GSK Investigational Site
state: California
city: San Jose
country: United States
facility: GSK Investigational Site
state: California
city: Walnut Creek
country: United States
facility: GSK Investigational Site
state: California
city: Englewood
country: United States
facility: GSK Investigational Site
state: Colorado
city: Miami
country: United States
facility: GSK Investigational Site
state: Florida
city: Sarasota
country: United States
facility: GSK Investigational Site
state: Florida
city: Tallahassee
country: United States
facility: GSK Investigational Site
state: Florida
city: Vero Beach
country: United States
facility: GSK Investigational Site
state: Florida
city: Stockbridge
country: United States
facility: GSK Investigational Site
state: Georgia
city: Chicago
country: United States
facility: GSK Investigational Site
state: Illinois
city: Chicago
country: United States
facility: GSK Investigational Site
state: Illinois
city: South Bend
country: United States
facility: GSK Investigational Site
state: Indiana
city: Shreveport
country: United States
facility: GSK Investigational Site
state: Louisiana
city: Bethesda
country: United States
facility: GSK Investigational Site
state: Maryland
city: Wheaton
country: United States
facility: GSK Investigational Site
state: Maryland
city: North Dartmouth
country: United States
facility: GSK Investigational Site
state: Massachusetts
city: Detroit
country: United States
facility: GSK Investigational Site
state: Michigan
city: Jackson
country: United States
facility: GSK Investigational Site
state: Mississippi
city: Saint Louis
country: United States
facility: GSK Investigational Site
state: Missouri
city: Bricktown
country: United States
facility: GSK Investigational Site
state: New Jersey
city: Skillman
country: United States
facility: GSK Investigational Site
state: New Jersey
city: Ithaca
country: United States
facility: GSK Investigational Site
state: New York
city: Rochester
country: United States
facility: GSK Investigational Site
state: New York
city: Sylvania
country: United States
facility: GSK Investigational Site
state: Ohio
city: Blue Bell
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Providence
country: United States
facility: GSK Investigational Site
state: Rhode Island
city: Chattanooga
country: United States
facility: GSK Investigational Site
state: Tennessee
city: Dallas
country: United States
facility: GSK Investigational Site
state: Texas
city: Dallas
country: United States
facility: GSK Investigational Site
state: Texas
city: San Antonio
country: United States
facility: GSK Investigational Site
state: Texas
city: South Burlington
country: United States
facility: GSK Investigational Site
state: Vermont
city: Winnipeg
country: Canada
facility: GSK Investigational Site
state: Manitoba
city: Hamilton
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Ottawa
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Trois Rivières
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Brno
country: Czechia
facility: GSK Investigational Site
city: Pardubice
country: Czechia
facility: GSK Investigational Site
city: Plzen
country: Czechia
facility: GSK Investigational Site
city: Praha 5
country: Czechia
facility: GSK Investigational Site
city: Weinheim
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Nuernberg
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Wiesbaden
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Oslo
country: Norway
facility: GSK Investigational Site
city: Oslo
country: Norway
facility: GSK Investigational Site
city: Ponce
country: Puerto Rico
facility: GSK Investigational Site
city: Bucharest
country: Romania
facility: GSK Investigational Site
city: Iasi
country: Romania
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: