common cold Rhinosinusitis
Conditions
Interventions
Acute rhinosinusitis will be treated according to the GP choice in one group.
The other group will be treated following de EPOS guidlines.
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: males and females aged >18 years Availability of an internetconnection written informed consent
Exclusion criteria
Exclusion criteria: 1. Symptoms or signs of extrasinus complications 2. Use of topical antimicrobial agents in the nose, intranasal corticosteroids, systemic steroids, or immunosuppressive drugs during the previous 30 days 3. Use of oral antibiotics during the previous 30 days 4. Significant anatomic abnormalities affecting nasal function 5. Nasal surgery during the previous three months 6. Subjects who have any serious or unstable concurrent disease 7. Pregnant or lactating women 8. Subjects with chronic rhinosinusitis (symptoms for longer than 12 weeks), nasal polyps or a history of nasal polyps 9. Inability to follow the instructions within this protocol 10. Contra-indications for studymedication
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint will be the time to symptom resolution compatible with normal daily activities based on major symptom score (MSS, as also defined by Meltzer). MSS is the sum of rhinorrhea, postnasal drip, nasal congestion/stuffiness, sinus headache and facial pain/pressure/tenderness on palpitation over the paranasal sinuses. With this score patients can report the severity of the symptoms of rhinosinusitis are to them on a 0 to 3 scale. At inclusion each patient will be provided with an electronic online diary and will be asked to record symptoms twice daily in the first 14 days and once daily from day 15 untill day 21, using the MSS. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Mean MSS after treatment of ARS - Therapeutic response: using the Global Rating of Response to treatment on a 7-point scale as follows: -3 severely worse; -2 moderately worse; -1 mildly worse; 0 no change; 1 mild relief; 2 moderate relief; 3 complete relief - Change in QoL (Quality of Life): RhinoQOL items (14 questions) to determine patient's quality of life on day 1, 7 and 21 - Adverse events: patients will record adverse events or unusual healthrelated events on the electronic diary daily. | — |
Countries
Netherlands
Outcome results
None listed