Management of Acute Rhinosinusitis: Implementation of Guidelines in General Practice

Withdrawn

Conditions: common cold
Rhinosinusitis
10024970

Registration Number: NL-OMON36879

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 1000

Inclusion Criteria

males and females aged >18 years
Availability of an internetconnection
written informed consent

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoint will be the time to symptom resolution compatible with normal<br /><br>daily activities based on major symptom score (MSS, as also defined by<br /><br>Meltzer). MSS is the sum of rhinorrhea, postnasal drip, nasal<br /><br>congestion/stuffiness, sinus headache and facial pain/pressure/tenderness on<br /><br>palpitation over the paranasal sinuses. With this score patients can report the<br /><br>severity of the symptoms of rhinosinusitis are to them on a 0 to 3 scale.<br /><br>At inclusion each patient will be provided with an electronic online diary and<br /><br>will be asked to record symptoms twice daily in the first 14 days and once<br /><br>daily from day 15 untill day 21, using the MSS. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Mean MSS after treatment of ARS<br /><br>- Therapeutic response: using the Global Rating of Response to treatment on a<br /><br>7-point scale as follows: -3 severely worse; -2 moderately worse; -1 mildly<br /><br>worse; 0 no change; 1 mild relief; 2 moderate relief; 3 complete relief<br /><br>- Change in QoL (Quality of Life): RhinoQOL items (14 questions) to determine<br /><br>patient's quality of life on day 1, 7 and 21<br /><br>- Adverse events: patients will record adverse events or unusual healthrelated<br /><br>events on the electronic diary daily.</p><br>