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PRET-study

Optimal treatment of rhinosinusitis-like symptoms: Double-blind placebo controleed randomized study with prednisolone versus usual care treatment

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON26931
Enrollment
200
Registered
2008-04-23
Start date
2008-09-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rhinosinusitis-like symptoms Rhinosinusitis Sinusitis Rhinosinusitis-achtige klachten Rhinosinusitis Sinusitis

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

Sponsors

Julius Center for Health Sciences and Primary Care, UMC Utrecht
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients with RS for at least 5 days 2. Age > 18 years

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Resolution of facial pain at day 7

Secondary

MeasureTime frame
- Resumption of daily activities (school/work) - Health related quality of life - Cost-effectiveness

Contacts

Public ContactR.P. Venekamp

Julius Center for Health Sciences and Primary Care, UMC Utrecht Postbus 85500

r.p.venekamp@umcutrecht.nl+31 (0)88 7555100

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)