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

This study has been completed.

First Received: July 1, 2005 Last Updated: May 15, 2009 History of Changes

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00118703

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

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

Resource links provided by NLM:

Drug Information available for: GW 685698X GW 685698

U.S. FDA Resources

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 (every 12 hours) reporting the severity of their VMR (vasomotor rhinitis) 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 this overall evaluation of response to therapy during the last clinic visit.

Estimated Enrollment:	350
Study Start Date:	July 2005

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 (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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00118703

Show 43 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	FFR30007
Study First Received:	July 1, 2005
Last Updated:	May 15, 2009
ClinicalTrials.gov Identifier:	NCT00118703 History of Changes
Health Authority:	United States: Food and Drug Administration; Canada: Health Canada; Norway: Norwegian Medicines Agency; European Union: European 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:

Otorhinolaryngologic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

Rhinitis, Vasomotor
Rhinitis
Nose Diseases

ClinicalTrials.gov processed this record on September 09, 2009