Study Of Perennial Allergic Rhinitis In Pediatrics
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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. |
ClinicalTrials.gov Identifier: NCT00253058 |
Recruitment Status :
Completed
First Posted : November 15, 2005
Last Update Posted : May 6, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Rhinitis, Allergic, Perennial | Drug: Cetirizine Dry Syrup | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 286 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double |
Primary Purpose: | Treatment |
Official Title: | Evaluation of the Efficacy and Safety of Cetirizine Dry Syrup in Children -Suffering From Perennial Allergic Rhinitis- |
Study Start Date : | July 2005 |

- change in the total nasal symptom score (TNSS)
- - Individual daily nasal symptom score - Investigator global improvement/patient global improvement - Nasal findings - Cetirizine serum concentrations - Adverse events

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Ages Eligible for Study: | 3 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 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.

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): NCT00253058
Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Responsible Party: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00253058 |
Other Study ID Numbers: |
104912 |
First Posted: | November 15, 2005 Key Record Dates |
Last Update Posted: | May 6, 2013 |
Last Verified: | May 2013 |
Allergic pediatric Rhinitis Perennial |
Rhinitis Rhinitis, Allergic Rhinitis, Allergic, Perennial Respiratory Tract Infections Infections Nose Diseases Respiratory Tract Diseases 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 |