- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01205984
Systemic Methylprednisolone in Chronic Rhinosinusitis
Efficacy and Tolerability of Systemic Methylprednisolone in Children and Adolescents With Chronic Rhinosinusitis
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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Ankara, Turkey, 06500
- Gazi University Faculty of Medicine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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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Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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PLACEBO_COMPARATOR: placebo
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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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ACTIVE_COMPARATOR: oral methylprednisolone
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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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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean change in total symptom score and coronal CT score after treatment
Time Frame: One month
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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.
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One month
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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mean changes in individual symptom scores after treatment
Time Frame: One month
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One month
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relapse rate
Time Frame: Six months
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Six months
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tolerability of oral methylprednisolone tablet
Time Frame: One month
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One month
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Fadıl Ozturk, Ondokuz Mayıs University, Samsun, Turkey Gazi University,Ankara, Turkey
- Study Director: Ipek Turktas, Gazi University, Ankara, Turkey
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Otorhinolaryngologic Diseases
- Paranasal Sinus Diseases
- Nose Diseases
- Sinusitis
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Autonomic Agents
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Antiemetics
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Neuroprotective Agents
- Protective Agents
- Anti-Bacterial Agents
- beta-Lactamase Inhibitors
- Prednisolone
- Methylprednisolone Acetate
- Methylprednisolone
- Methylprednisolone Hemisuccinate
- Prednisolone acetate
- Prednisolone hemisuccinate
- Prednisolone phosphate
- Amoxicillin-Potassium Clavulanate Combination
Other Study ID Numbers
- CRS-0655-IF
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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