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

Vasomotor Rhinitis Clinical Trial

Official title:

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Once-Daily, Intranasal Administration of GW685698X Aqueous Nasal Spray 100mcg for 4 Weeks in Adult and Adolescent Subjects (12 Years of Age and Older) With Vasomotor Rhinitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00118703
• Other study ID #: FFR30007
• Status: Completed
• Phase: Phase 3
• First received: July 1, 2005
• Last updated: September 22, 2016
• Start date: July 2005
• Est. completion date: February 2006

Study information

• Verified date: September 2016
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: European Union: European Medicines AgencyUnited States: Food and Drug AdministrationNorway: Norwegian Medicines AgencyCanada: Health Canada
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 350
• Est. completion date: February 2006
• Est. primary completion date: January 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Rhinitis
• Rhinitis, Vasomotor
• Vasomotor Rhinitis

Intervention

Drug:
• GW685698X

Locations

Country	Name	City	State
Canada	GSK Investigational Site	Hamilton	Ontario
Canada	GSK Investigational Site	Ottawa	Ontario
Canada	GSK Investigational Site	Trois Rivières	Quebec
Canada	GSK Investigational Site	Winnipeg	Manitoba
Czech Republic	GSK Investigational Site	Brno
Czech Republic	GSK Investigational Site	Pardubice
Czech Republic	GSK Investigational Site	Plzen
Czech Republic	GSK Investigational Site	Praha 5
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Nuernberg	Bayern
Germany	GSK Investigational Site	Weinheim	Baden-Wuerttemberg
Germany	GSK Investigational Site	Wiesbaden	Hessen
Norway	GSK Investigational Site	Oslo
Norway	GSK Investigational Site	Oslo
Puerto Rico	GSK Investigational Site	Ponce
Romania	GSK Investigational Site	Bucharest
Romania	GSK Investigational Site	Iasi
United States	GSK Investigational Site	Bethesda	Maryland
United States	GSK Investigational Site	Birmingham	Alabama
United States	GSK Investigational Site	Blue Belle	Pennsylvania
United States	GSK Investigational Site	Brick	New Jersey
United States	GSK Investigational Site	Chattanooga	Tennessee
United States	GSK Investigational Site	Chicago	Illinois
United States	GSK Investigational Site	Chicago	Illinois
United States	GSK Investigational Site	Dallas	Texas
United States	GSK Investigational Site	Dallas	Texas
United States	GSK Investigational Site	Detroit	Michigan
United States	GSK Investigational Site	Englewood	Colorado
United States	GSK Investigational Site	Fresno	California
United States	GSK Investigational Site	Irvine	California
United States	GSK Investigational Site	Ithaca	New York
United States	GSK Investigational Site	Jackson	Mississippi
United States	GSK Investigational Site	Little Rock	Arkansas
United States	GSK Investigational Site	Los Angeles	California
United States	GSK Investigational Site	Miami	Florida
United States	GSK Investigational Site	North Dartmouth	Massachusetts
United States	GSK Investigational Site	Orange	California
United States	GSK Investigational Site	Paramount	California
United States	GSK Investigational Site	Phoenix	Arizona
United States	GSK Investigational Site	Providence	Rhode Island
United States	GSK Investigational Site	Rochester	New York
United States	GSK Investigational Site	Sacramento	California
United States	GSK Investigational Site	San Antonio	Texas
United States	GSK Investigational Site	San Francisco	California
United States	GSK Investigational Site	San Jose	California
United States	GSK Investigational Site	Sarasota	Florida
United States	GSK Investigational Site	Shreveport	Louisiana
United States	GSK Investigational Site	Skillman	New Jersey
United States	GSK Investigational Site	South Bend	Indiana
United States	GSK Investigational Site	South Burlington	Vermont
United States	GSK Investigational Site	St. Louis	Missouri
United States	GSK Investigational Site	Stockbridge	Georgia
United States	GSK Investigational Site	Sylvania	Ohio
United States	GSK Investigational Site	Tallahassee	Florida
United States	GSK Investigational Site	Vero Beach	Florida
United States	GSK Investigational Site	Walnut Creek	California
United States	GSK Investigational Site	Wheaton	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

United States,  Canada,  Czech Republic,  Germany,  Norway,  Puerto Rico,  Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change from baseline over the entire treatment period in daily, reflective total nasal symptom scores. Subjects complete diaries twice daily (every 12 hours) reporting the severity of their VMR (vasomotor rhinitis) symptoms.			No
Secondary	Mean change from baseline over the entire treatment period in AM, pre-dose, instantaneous total nasal symptom scores. The subject completes this overall evaluation of response to therapy during the last clinic visit.			No

External Links

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