Systemic Methylprednisolone in Chronic Rhinosinusitis

NCT01205984 | Completed Phase 4 DMC

• 1 other identifier: CRS-0655-IF
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Rhinosinusitis; Children

Keywords

Chronic rhinosinusitis; Computed tomography scan; Methylprednisolone

Outcome Measures

Primary Outcomes (1)

• Mean change in total symptom score and coronal CT score after treatment

  Rhinosinusitis symptoms were assessed by the patients and their parents with the use of a visual analogue scale (VAS) rating symptoms from 0 (none) to 10 (most severe). A coronal sinus CT scanning was performed on all subjects before and at the end of the treatment. The scans were evaluated and scored according to the Lund-Mackay staging system.

  One month

Secondary Outcomes (3)

• mean changes in individual symptom scores after treatment

  One month

• relapse rate

  Six months

• tolerability of oral methylprednisolone tablet

  One month

Study Arms (2)

oral methylprednisolone

ACTIVE COMPARATOR

Drug: methylprednisolone

placebo

PLACEBO COMPARATOR

Drug: methylprednisolone

Interventions

methylprednisolone DRUG

Patients enrolled in the study were given either oral amoxicillin/clavulanate (AMX/C) or metylprednisolone (MP) (group MP) or AMX/C and placebo (group P) twice daily using a random allocation chart based on a table of random numbers. Oral AMX/C was administered 45/6.4 mg/kg/d (maximum 2000/285 mg/d) for 30 days for both groups. Oral MP was administered for the first 15 days: 1 mg/kg/d (maximum 40 mg/d) for 10 days, 0.75 mg/kg/d for 2 days, 0.5 mg/kg/d for 2 days, and 0.25 mg/kg/d for 1 day. Placebo tablets contained lactose and were of same size and color as MP tablets.

Also known as: Prednol tablet, Augmentin suspension/tablet

oral methylprednisolone; placebo

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

Sponsors & Collaborators

• Ondokuz Mayıs University: lead

Study Sites (1)

Gazi University Faculty of Medicine

Ankara, 06500, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Methylprednisolone; Tablets

Intervention Hierarchy (Ancestors)

Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Fadıl Ozturk

  Ondokuz Mayıs University, Samsun, Turkey Gazi University,Ankara, Turkey

  PRINCIPAL INVESTIGATOR

• Ipek Turktas

  Gazi University, Ankara, Turkey

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 20, 2010
• First Posted: September 21, 2010
• Study Start: July 1, 2007
• Primary Completion: September 1, 2009
• Study Completion: April 1, 2010
• Last Updated: September 21, 2010

Record last verified: 2010-09

Locations

TU (1)