Overview

Systemic Methylprednisolone in Chronic Rhinosinusitis

Status:
Completed

Trial end date:
2010-04-01

Target enrollment:
0

Participant gender:
All

Summary

The place of systemic corticosteroids in the treatment of children with chronic rhinosinusitis (CRS) remains unclear. We aimed to assess the effectiveness and tolerability of oral methylprednisolone (MP) as an anti-inflammatory adjunct in the treatment of CRS in children.Forty-eight children (age 6-17 years) with clinically and radiologically proven CRS were included. Patients were randomly assigned to either oral amoxicillin/clavulanate (AMX/C) and MP or AMX/C and placebo (P) twice daily for 30 days. Oral MP was administered for the first 15 days with a tapering schedule. Primary parameters were mean change in symptom and sinus computed tomography (CT) scan scores after treatment. Secondary study parameters were mean changes in individual symptom scores after treatment, relapse rate and tolerability. Forty-five patients completed the study, 22 received AMX/C and MP, and 23 AMX/C and P. Both groups demonstrated significant improvements in symptom and sinus CT scores, comparing baseline to end of the treatment (p<0.001). Methylprednisolone as an adjunct was significantly more effective than placebo in reducing CT scores (p=0.004), total rhinosinusitis symptoms (p=0.001) and individual symptoms of nasal obstruction (p=0.001), postnasal discharge (p=0.007), and cough (p=0.009). At the end of the treatment, 48% of the children in the P group still had abnormal findings in CT versus 14% in the MP group (p = 0.013). Therapy-related adverse events were not different between groups. Although insignificant, the incidence of clinical relapses was also less in the MP group (25%) compared to P group (43%) (p = 0.137). Oral MP is well tolerated and provides added benefit to treatment with antibiotics for children with CRS.

Phase:

Phase 4

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Ondokuz Mayıs University

Treatments:

Amoxicillin-Potassium Clavulanate Combination
Methylprednisolone
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate

Criteria

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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