Rhinitis, Allergic, Perennial
Conditions
Keywords
Perennial allergic rhinitis, pediatric
Brief summary
The purpose of this study is to determine if the investigational drug is effective and safe in children with perennial allergic rhinitis.
Detailed description
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Safety and Efficacy of Once-Daily, Intranasal Administration of GW685698X Aqueous Nasal Spray 50mcg and 100mcg for 12 Weeks in Pediatric Subjects Ages 2 to \<12 Years with Perennial Allergic Rhinitis (PAR)
Interventions
DRUGGW685698X
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
2 Years to 12 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of perennial allergic rhinitis.
Exclusion criteria
* Have significant concomitant medical conditions. * Use of corticosteroids or other allergy medications during the study. * Have abnormal ECG. * Have laboratory abnormality. * Have abnormal eye exam.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in daily, reflective total nasal symptom scores after first 4-week treatment period in subjects ages 6 to <12 years. | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvement in AM, pre-dose, instantaneous total nasal symptom scores after first 4-week treatment period, overall evaluation of response to therapy for the first 4-week treatment period for subjects ages 6 to <12 years. | — |
Countries
Argentina, Chile, Finland, Italy, Mexico, Slovakia, United States
Outcome results
None listed