Inflammatory mediators in nasal discharge of chronic rhinosinusitis patients treated with erythromycin.

Phase 3

• Conditions: MedDRA - 10009137: Chronic sinusitis; J32; Chronic sinusitis

• Registration Number: DRKS00000086
• Lead Sponsor: Johannes Gutenberg Universität Mainz

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-02-19
• Study Completion: 2012-08-03
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting stopped after recruiting started
• Sex: All
• Target Recruitment: 58

Inclusion Criteria

There is a preoperative allergy testing.
- There is a histology finding.
- There is a CT scan of the sinuses, which confirmed the diagnosis of chronic rhinosinusitis.
- Candidates in the location, type, extent and consequences of individual clinical trial is to be understood. - A lies in front of the candidates personally signed and dated consent form before any test-specific measure is implemented.
- Women who are postmenopausal for more than two years, to attend the trial. Women of childbearing age can only participate in the trial if they are surgically sterile, or if they are willing to use reliable contraception during the trial and up to two months after the end of the trial.

Exclusion Criteria

- Pregnancy and lactation.
- Hypersensitivity to the investigational product or a chemically related substance or a component of the investigational product or placebo.
- The existence of a unilateral rhinosinusitis, a tumor of the paranasal sinuses, a fungal sinusitis, sinusitis in cystic fibrosis or a part of a syndrome of immotile cilia.
- Well-known liver or kidney disease, electrolyte disturbances or heart rhythm disturbances, especially QT interval prolongations.
- Regular use of drugs, of which a known interaction is known with simultaneous administration of macrolides.
- Participation in other clinical trials during or within 6 months prior to this trial.
- Medical or psychological circumstances that may endanger the proper conduct of the trial.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Concentration changes of inflammation mediatiors MPO and ECP in nasal discharge under a low-dose erythromycin or placebo post-operative treatment.

Secondary Outcome Measures

Name	Time	Method
Concentration changes of IL-5 and IL-8 in nasal discharge || Changes of saccharine transport time || Changes of SNOT-20 GAV || Changes of subjective nasal health (VAS) || Changes of the Sniffin´ Sticks test score || Changes of the nasal endoscopy score || Alterations in the nasal swab