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

This study has been completed.
Information provided by (Responsible Party):
ClinicalTrials.gov Identifier:
First received: July 1, 2005
Last updated: April 14, 2015
Last verified: April 2015
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
Rhinitis, Vasomotor
Drug: GW685698X
Phase 3

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

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

Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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

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Sponsors and Collaborators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00118703     History of Changes
Other Study ID Numbers: FFR30007 
Study First Received: July 1, 2005
Last Updated: April 14, 2015
Health Authority: European Union: European Medicines Agency
Norway: Norwegian Medicines Agency
Canada: Health Canada
United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
nonallergic rhinitis
vasomotor rhinitis

Additional relevant MeSH terms:
Rhinitis, Vasomotor
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on August 22, 2016