Study Of Adults And Adolescents With Vasomotor Rhinitis - Full Text View

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00117325

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	Drug: GW685698X	Phase III

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Mean change from baseline over the entire treatment period in daily, reflective total nasal symptom scores. Subjects complete diaries twice daily reporting the severity of their VMR symptoms.

Secondary Outcome Measures:

Mean change from baseline over the entire treatment period in AM, pre-dose, instantaneous total nasal symptom scores. The subject completes an overall evaluation of response to therapy during the last clinic visit.

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

Eligibility

Ages Eligible for Study:	12 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion criteria:

Must be outpatients.
Diagnosis of VMR.
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00117325

Show 46 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	FFR30006
Study First Received:	June 30, 2005
Last Updated:	October 13, 2008
ClinicalTrials.gov Identifier:	NCT00117325
Health Authority:	United States: Food and Drug Administration; Canada: Health Canada; Norway: Norwegian Medicines Agency

Keywords provided by GlaxoSmithKline:

Vasomotor Rhinitis
nonallergic rhinitis
GW685698X
VMR

Study placed in the following topic categories:

Otorhinolaryngologic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Rhinitis, Vasomotor
Rhinitis

Additional relevant MeSH terms:

Nose Diseases

ClinicalTrials.gov processed this record on January 14, 2009