Systemic Methylprednisolone in Chronic Rhinosinusitis
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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 |
- 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.
- 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:
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| 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:
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Eligibility| Ages Eligible for Study: | 6 Years to 17 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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| Turkey | |
| Gazi University Faculty of Medicine | |
| Ankara, Turkey, 06500 | |
| 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 Neuroprotective Agents Protective Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents |
ClinicalTrials.gov processed this record on May 22, 2013