Clinical trial NCT01205984: Systemic Methylprednisolone in Chronic Rhinosinusitis
Official title: Efficacy and Tolerability of Systemic Methylprednisolone in Children and Adolescents With Chronic Rhinosinusitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Rhinosinusitis
Children
Keywords: Chronic rhinosinusitis
Computed tomography scan
Methylprednisolone
Lead sponsor: Ondokuz Mayıs University
Sponsor class: OTHER
First posted: 2010-09-21
Enrollment: 48
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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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Primary outcomes:
measure: Mean change in total symptom score and coronal CT score after treatment
timeFrame: One month
Secondary outcomes:
measure: mean changes in individual symptom scores after treatment
timeFrame: One month
measure: relapse rate
timeFrame: Six months
measure: tolerability of oral methylprednisolone tablet
timeFrame: One month
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gazi University Faculty of Medicine
Study officials:
affiliation: Ondokuz Mayıs University, Samsun, Turkey Gazi University,Ankara, Turkey
name: Fadıl Ozturk
role: PRINCIPAL_INVESTIGATOR
affiliation: Gazi University, Ankara, Turkey
name: Ipek Turktas
role: STUDY_DIRECTOR
References: