PRET-study

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.

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 (¡Ý 18 yrs) with RS for ¡Ý 5 days.


Exclusion: ¡Ý 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.

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.

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.

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.