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Perennial Allergic Rhinitis In Pediatric Subjects

This study has been completed.
Information provided by (Responsible Party):
GlaxoSmithKline Identifier:
First received: November 21, 2005
Last updated: May 3, 2013
Last verified: May 2013
To assess the safety of long-term use of cetirizine dry syrup in children with perennial allergic rhinitis.

Condition Intervention Phase
Rhinitis, Allergic, Perennial Drug: Cetirizine Dry Syrup Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Long-term Study of Cetirizine Dry Syrup in Children. Suffering From Perennial Allergic Rhinitis.

Resource links provided by NLM:

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • safety

Secondary Outcome Measures:
  • Total Nasal Symptom Score (TNSS) Individual nasal symptom score total score of 4 individual daily symptom scores Investigator global improvement rating

Estimated Enrollment: 30
Study Start Date: August 2005

Ages Eligible for Study:   2 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts 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.
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Please refer to this study by its identifier: NCT00257595

Sponsors and Collaborators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Responsible Party: GlaxoSmithKline Identifier: NCT00257595     History of Changes
Other Study ID Numbers: 104914
Study First Received: November 21, 2005
Last Updated: May 3, 2013

Keywords provided by GlaxoSmithKline:
Perennial Allergic Rhinitis pediatric

Additional relevant MeSH terms:
Rhinitis, Allergic
Rhinitis, Allergic, Perennial
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Anti-Allergic Agents
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs processed this record on August 17, 2017