Once-Daily Investigational Nasal Spray In Adults And Adolescents With Vasomotor Rhinitis
This study has been completed.
Information provided by (Responsible Party):
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).
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
||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
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.
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||January 2006 (Final data collection date for primary outcome measure)
Other Name: GW685698X
|Ages Eligible for Study:
||12 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Must be outpatients.
- Diagnosis of VMR (vasomotor rhinitis).
- Literate in English or native language.
- Significant concomitant medical condition.
- Use corticosteroids or other allergy medications during the study.
- Used tobacco products within the past year.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00118703
||GSK Clinical Trials
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||July 1, 2005
||April 14, 2015
||European Union: European Medicines Agency
Norway: Norwegian Medicines Agency
Canada: Health Canada
United States: Food and Drug Administration
Keywords provided by GlaxoSmithKline:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on July 28, 2015
Respiratory Tract Diseases
Respiratory Tract Infections