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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01205984 |
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Date of registration:
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20/09/2010 |
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Primary sponsor: |
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Public title:
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Systemic Methylprednisolone in Chronic Rhinosinusitis
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Scientific title:
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Efficacy and Tolerability of Systemic Methylprednisolone in Children and Adolescents With Chronic Rhinosinusitis |
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Date of first enrolment:
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July 2007 |
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Target sample size:
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48 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01205984 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Countries of recruitment
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Turkey
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Contacts
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Name:
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Ipek Turktas |
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Address:
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Telephone:
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Email:
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Affiliation:
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Gazi University, Ankara, Turkey |
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Name:
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Fadil Ozturk |
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Address:
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Telephone:
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Email:
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Affiliation:
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Ondokuz Mayis University, Samsun, Turkey Gazi University,Ankara, Turkey |
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Key inclusion & exclusion criteria
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Inclusion Criteria:All patients presented with nasal and/or postnasal purulence, and one
or more of the following symptoms: nasal obstruction, cough, halitosis, headache, or
facial pain/pressure. The diagnosis of CRS was made on the basis of sinonasal symptoms and
signs present for a period of more than 3 months in the presence of abnormalities on
coronal sinus CT scans.
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Exclusion Criteria:Patients were excluded if they had used systemic corticosteroids in the
last 2 months prior to the study, systemic antibiotics and inhaler or intranasal
corticosteroids in the last 4 weeks prior to the study or if they had other respiratory
disorders (cystic fibrosis, ciliary dyskinesia, nasal polyps, large adenoids, asthma),
immune deficiency, systemic disease, gastro-esophageal reflux, aspirin sensitivity, and
acquired or congenital sinonasal abnormalities, or a contraindication to corticosteroid
use.
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Age minimum:
6 Years
Age maximum:
17 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Children
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Chronic Rhinosinusitis
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Intervention(s)
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Drug: methylprednisolone
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Primary Outcome(s)
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Mean change in total symptom score and coronal CT score after treatment
[Time Frame: One month]
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Secondary Outcome(s)
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mean changes in individual symptom scores after treatment
[Time Frame: One month]
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relapse rate
[Time Frame: Six months]
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tolerability of oral methylprednisolone tablet
[Time Frame: One month]
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Secondary ID(s)
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CRS-0655-IF
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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