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PRET-study


- candidate number3229
- NTR NumberNTR1295
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR23-apr-2008
- Secondary IDs2008-000560-17 EudraCT number
- Public TitlePRET-study
- Scientific TitleOptimal treatment of rhinosinusitis-like symptoms: Double-blind placebo controleed randomized study with prednisolone versus usual care treatment
- ACRONYMPrednisolone Rhinosinusitis Efficacy Trial (PRET) - study
- hypothesisThere 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) studiedRhinosinusitis, Sinusitis
- Inclusion criteria1. Patients with RS for at least 5 days
2. Age > 18 years
- Exclusion criteria1. 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 receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-sep-2008
- planned closingdate31-dec-2009
- Target number of participants200
- InterventionsAll 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 outcomeResolution of facial pain at day 7
- Secondary outcome- Resumption of daily activities (school/work)
- Health related quality of life
- Cost-effectiveness
- TimepointsCFR: 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 siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESMD, PhD student R.P. Venekamp
- CONTACT for SCIENTIFIC QUERIESMD, PhD student R.P. Venekamp
- Sponsor/Initiator Julius Center for Health Sciences and Primary Care
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- PublicationsN/A
- Brief summaryRationale:
"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.

Objective:
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.

Study design:
Double-blind placebo controlled randomized clinical trial.

Study population.
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.

Intervention:
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.

Main endpoints:
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.

Statistical analysis:
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)
- RECORD23-apr-2008 - 1-mei-2011


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