Once-Daily Investigational Nasal Spray In Adults And Adolescents With Perennial Allergic Rhinitis (PAR)
This study has been completed.
Information provided by:
First received: February 8, 2006
Last updated: November 6, 2007
Last verified: November 2007
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 perennial allergic rhinitis (PAR).
Perennial Allergic Rhinitis
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
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 6 Weeks in Adult and Adolescent Subjects 12 Years of Age and Older With Perennial Allergic Rhinitis (PAR)
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 PAR symptoms. [ Time Frame: throughout study ]
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. [ Time Frame: throughout study ]
| Study Start Date:
| Study Completion Date:
|Ages Eligible for Study:
||12 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Diagnosis of perennial allergic rhinitis (PAR).
- Must comply with study procedures and be literate.
- Significant concomitant medical conditions.
- Use of corticosteroids.
- Use of allergy and other identified medications during the study.
- Current tobacco use or tobacco use within the past year.
- Exposure to an investigational study drug within the past 12 months.
- Clinically significant abnormal electrocardiograms (ECG) or laboratory abnormality.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00289198
||GlaxoSmithKline Clinical Trials, MD
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||February 8, 2006
||November 6, 2007
||United States: Food and Drug Administration
Canada: Health Canada
Keywords provided by GlaxoSmithKline:
perennial allergic rhinitis
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on July 20, 2014
Rhinitis, Allergic, Perennial
Respiratory Tract Diseases
Respiratory Tract Infections
Immune System Diseases