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Completed

NCT Number: NCT00253058

Study Of Perennial Allergic Rhinitis In Pediatrics

To verify of cetirizine dry syrup to ketotifen dry syrup in the change of total nasal symptom score (TNSS) over the total treatment period from the score of the baseline assessment period

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Key information

Conditions

Rhinitis, Allergic, Perennial Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Infections Nose Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Respiratory Tract Diseases Respiratory Tract Infections Rhinitis Rhinitis, Allergic

Age range

3 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

GSK Investigational Site

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 spastic disease such as epilepsy
  • have a history of drug hypersensitivity
  • are pregnant, lactating or possibly pregnant female Children
  • are sensitive 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 or 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.

Treatment and study plan

Cetirizine Dry Syrup

Drug

Primary outcomes

  1. change in the total nasal symptom score (TNSS)

Secondary outcomes

  1. - Individual daily nasal symptom score - Investigator global improvement/patient global improvement - Nasal findings - Cetirizine serum concentrations - Adverse events

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

Evaluation of the Efficacy and Safety of Cetirizine Dry Syrup in Children -Suffering From Perennial Allergic Rhinitis-

Important dates

Study start
2005
First posted
Nov 15, 2005
Registry last updated
May 6, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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