SOPAZITHRO : Evaluation of the Efficacy of 3-month Continuous Extended Treatment With Azithromycin in Idiopathic Purulent Oedematous Sinusitis in Adults: a Multicentre Randomised Controlled Trial

Conditions

Ear, nose and throat diseases

Brief summary

Comparison of sinonasal outcome test (SNOT) 22 specific quality of life score averages

Detailed description

Number of infectious rhinosinus exacerbations, Number of courses of antibiotics use, Visual analog scales of symptoms, Semi-quantitative symptom scale, Semi-quantitative nasal endoscopy score, Quantitative Lund MacKay CT score, Nasal inflammation flow, General quality of life Short form-36 (SF-36), Days off work, Olfactory score, Bacteria present on the protected nasal swab, Number of participants with clinical adverse events as assessed by compliance, Number of participants with biological adverse events as assessed by compliance, Residual effect of the treatment using the SNOT 22 quality of life questionnaire, Residual effect of the treatment using the SF-36 quality of life questionnaires, Residual effect of the treatment using the VAS score, Residual effect of the treatment using the semi-quantitative symptom scale, Residual effect of the treatment using the nasal endoscopy, Residual effect of the treatment using the bacteriological samples., Quantitative aspect of the ciliary beat, Qualitative aspect of the ciliary beat

Related papers

No related papers found yet.

Interventions

DRUGAzithromycin placebo

DRUGAZITHROMYCIN

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Comparison of sinonasal outcome test (SNOT) 22 specific quality of life score averages	—

Secondary

Measure	Time frame
Number of infectious rhinosinus exacerbations, Number of courses of antibiotics use, Visual analog scales of symptoms, Semi-quantitative symptom scale, Semi-quantitative nasal endoscopy score, Quantitative Lund MacKay CT score, Nasal inflammation flow, General quality of life Short form-36 (SF-36), Days off work, Olfactory score, Bacteria present on the protected nasal swab, Number of participants with clinical adverse events as assessed by compliance, Number of participants with biological adverse events as assessed by compliance, Residual effect of the treatment using the SNOT 22 quality of life questionnaire, Residual effect of the treatment using the SF-36 quality of life questionnaires, Residual effect of the treatment using the VAS score, Residual effect of the treatment using the semi-quantitative symptom scale, Residual effect of the treatment using the nasal endoscopy, Residual effect of the treatment using the bacteriological samples., Quantitative aspect of the ciliary beat,	—

Measure

Time frame

Number of infectious rhinosinus exacerbations, Number of courses of antibiotics use, Visual analog scales of symptoms, Semi-quantitative symptom scale, Semi-quantitative nasal endoscopy score, Quantitative Lund MacKay CT score, Nasal inflammation flow, General quality of life Short form-36 (SF-36), Days off work, Olfactory score, Bacteria present on the protected nasal swab, Number of participants with clinical adverse events as assessed by compliance, Number of participants with biological adverse events as assessed by compliance, Residual effect of the treatment using the SNOT 22 quality of life questionnaire, Residual effect of the treatment using the SF-36 quality of life questionnaires, Residual effect of the treatment using the VAS score, Residual effect of the treatment using the semi-quantitative symptom scale, Residual effect of the treatment using the nasal endoscopy, Residual effect of the treatment using the bacteriological samples., Quantitative aspect of the ciliary beat,

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Countries

France

Outcome results

None listed