Systemic Methylprednisolone in Chronic Rhinosinusitis

This study has been completed.
Sponsor:
Information provided by:
Ondokuz Mayıs University
ClinicalTrials.gov Identifier:
NCT01205984
First received: September 20, 2010
Last updated: NA
Last verified: September 2010
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Chronic Rhinosinusitis
Children
Drug: methylprednisolone
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy and Tolerability of Systemic Methylprednisolone in Children and Adolescents With Chronic Rhinosinusitis

Resource links provided by NLM:


Further study details as provided by Ondokuz Mayıs University:

Primary Outcome Measures:
  • Mean change in total symptom score and coronal CT score after treatment [ Time Frame: One month ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • mean changes in individual symptom scores after treatment [ Time Frame: One month ] [ Designated as safety issue: No ]
  • relapse rate [ Time Frame: Six months ] [ Designated as safety issue: No ]
  • tolerability of oral methylprednisolone tablet [ Time Frame: One month ] [ Designated as safety issue: Yes ]

Enrollment: 48
Study Start Date: July 2007
Study Completion Date: April 2010
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: oral methylprednisolone Drug: methylprednisolone
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.
Other Names:
  • Prednol tablet
  • Augmentin suspension/tablet
Placebo Comparator: placebo Drug: methylprednisolone
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.
Other Names:
  • Prednol tablet
  • Augmentin suspension/tablet

  Eligibility

Ages Eligible for Study:   6 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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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  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01205984

Locations
Turkey
Gazi University Faculty of Medicine
Ankara, Turkey, 06500
Sponsors and Collaborators
Ondokuz Mayıs University
Investigators
Principal Investigator: Fadıl Ozturk Ondokuz Mayıs University, Samsun, Turkey Gazi University,Ankara, Turkey
Study Director: Ipek Turktas Gazi University, Ankara, Turkey
  More Information

No publications provided

Responsible Party: Fadıl Ozturk, Ondokuz Mayıs University
ClinicalTrials.gov Identifier: NCT01205984     History of Changes
Other Study ID Numbers: CRS-0655-IF
Study First Received: September 20, 2010
Last Updated: September 20, 2010
Health Authority: Turkey: Ministry of Health

Keywords provided by Ondokuz Mayıs University:
Chronic rhinosinusitis
Computed tomography scan
Methylprednisolone

Additional relevant MeSH terms:
Sinusitis
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Methylprednisolone acetate
Prednisolone acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents
Protective Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on September 18, 2014