|- candidate number||3229|
|- NTR Number||NTR1295|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||23-apr-2008|
|- Secondary IDs||2008-000560-17 EudraCT number|
|- Public Title||PRET-study|
|- Scientific Title||Optimal treatment of rhinosinusitis-like symptoms: Double-blind placebo controleed randomized study with prednisolone versus usual care treatment|
|- ACRONYM||Prednisolone Rhinosinusitis Efficacy Trial (PRET) - study|
|- hypothesis||There is an ongoing discussion on the aetiology of rhinosinusitis-like symptoms (RS). Till recent years, the point of view was to consider RS as a bacterial infection to be treated with antiobiotics. However, most randomized placebo controlled trials (RCTs) in RS patients failed to show an overall beneficial effect. Nowadays, there is a strong tendency among experts to consider RS more an inflammatory disorder. As a consequence, anti-inflammatory agents might reduce inflammation and enhance clearances of the sinuses.
|- Healt Condition(s) or Problem(s) studied||Rhinosinusitis, Sinusitis|
|- Inclusion criteria||1. Patients with RS for at least 5 days |
2. Age > 18 years
|- Exclusion criteria||1. Fever > 38.5 C |
2. > 2 episodes of RS in the previous 12 months
(Chronic) use of either nasal or oral corticosteroids
Contraindication for prednisolone treatment
Previous ENT surgery for malignant disease
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-sep-2008|
|- planned closingdate||31-dec-2009|
|- Target number of participants||200|
|- Interventions||All patients receive usual care (symptomatic) treatment: xylomethazoline 0.1% nasal spray, paracetamol, steam therapy).
Patients will be randomly allocated to a daily dose of either prednisolone 30 mg during 7 days or placebo.|
|- Primary outcome||Resolution of facial pain at day 7|
|- Secondary outcome||- Resumption of daily activities (school/work)|
- Health related quality of life
|- Timepoints||CFR: visit day 1 |
CRF: visit day 14
Diary day 1-14: subjects will record symptoms, use of medication, absenteeism from school/work during 14 days
CRF GP after 8 weeks (follow-up period):
GP records all subjects' GP contacts
Survey (telephone) at 8 weeks:
subjects are asked to complete a (telephone) survey at the end of the study period performed by the coordinating investigator.
|- Trial web site||N/A|
|- status||stopped: trial finished|
|- CONTACT FOR PUBLIC QUERIES||MD, PhD student R.P. Venekamp|
|- CONTACT for SCIENTIFIC QUERIES||MD, PhD student R.P. Venekamp|
|- Sponsor/Initiator ||Julius Center for Health Sciences and Primary Care|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development|
|- Brief summary||Rationale: |
"Rhinosinusitis-like symptoms" (RS) are often interpreted by general practitioners in daily practice as a bacterial infection. Therefore, antibiotics are still prescribed in approximately 70-90%, despite most RCTs with antibiotics failed to show an overall beneficial clinical effect. Nowadays, there is a strong tendency among experts to consider RS more as an inflammatory disorder. As a consequence, anti-inflammatory agents might reduce inflammation and enhance clearance of the sinuses. Available evidence of the use of steroids is however still conflicting.
To assess the effects of a 7-day course of 30 mg prednisolone daily in addition to usual care (symptomatic) treatment in adults with RS.
Double-blind placebo controlled randomized clinical trial.
200 patients (¡Ư 18 yrs) with RS for ¡Ư 5 days.
Exclusion: ¡Ư 2 episodes of RS in the previous 12 months and chronic use of (intranasal) corticosteroids.
All patients will receive ¡®usual care¡¯ (xylomethazoline, paracetamol, steam therapy). Patients will be randomly allocated to a daily dose of either prednisolone 30 mg during 7 days or placebo.
Primary endpoint: resolution of facial pain at day 7.
Secondary endpoints: resumption of daily activities (school/work), health related quality of life and cost-effectiveness.
Intention-to-treat analysis. Difference between groups: chi-square test. Unexpected differences in potential confounders: multiple regression analysis. Survival analysis: Kaplan-Meyer curves, log-rank statistics and hazard ratios.
|- Main changes (audit trail)|
|- RECORD||23-apr-2008 - 1-mei-2011|