Rhinitis, Allergic, Perennial
Conditions
Keywords
Perennial Allergic Rhinitis pediatric
Brief summary
To assess the safety of long-term use of cetirizine dry syrup in children with perennial allergic rhinitis.
Interventions
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 14 Years
Healthy volunteers
No
Inclusion criteria
* Children with perennial allergic rhinitis. * Giving informed consent. * Children with a positive response to specific IgE antibody test. * Children assessed as positive in the nasal eosinophil count. * Children whose severity score of nasal symptom is 4 or higher.
Exclusion criteria
* have a history of drug hypersensitivity. * are pregnant, lactating or possibly pregnant female children. * Sensitivity to pollen as a duplicate allergen and whose treatment periods are thought in the pollen dispersion periods. * have vasomotor rhinitis and eosinophilic rhinitis. * have asthma that requires the treatment with corticosteroid. * have inappropriate complication of nasal disorder that may influence on the evaluation of the study drugs. * have complicated with atopic dermatitis or urticaria that requires the treatment with antihistamine preparation. * have started specific desensitization treatment. * nonspecific modulation treatment but who have not reached the maintenance level of treatment. * have received surgical treatment for reduction and modulation of nasal mucosa. * redintegration therapy of nasal cavity to improve the degree of nasal airway. * surgical operation to improve rhinorrhea.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety | — |
Secondary
| Measure | Time frame |
|---|---|
| Total Nasal Symptom Score (TNSS) Individual nasal symptom score total score of 4 individual daily symptom scores Investigator global improvement rating | — |
Outcome results
None listed