Status:
COMPLETED
Perennial Allergic Rhinitis In Pediatric Subjects
Lead Sponsor:
GlaxoSmithKline
Conditions:
Rhinitis, Allergic, Perennial
Eligibility:
All Genders
2-14 years
Phase:
PHASE3
Brief Summary
To assess the safety of long-term use of cetirizine dry syrup in children with perennial allergic rhinitis.
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00257595
Start Date
August 1 2005
Last Update
May 6 2013
Active Locations (1)
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1
GSK Investigational Site