We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Perennial Allergic Rhinitis In Pediatric Subjects

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00257595
First Posted: November 23, 2005
Last Update Posted: May 6, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
  Purpose
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
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   2 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00257595


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

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00257595     History of Changes
Other Study ID Numbers: 104914
First Submitted: November 21, 2005
First Posted: November 23, 2005
Last Update Posted: May 6, 2013
Last Verified: May 2013

Keywords provided by GlaxoSmithKline:
Perennial Allergic Rhinitis pediatric

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic
Rhinitis, Allergic, Perennial
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Cetirizine
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