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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-005828-84-DE

Enrollment

Registered

2009-01-28

Start date

2009-04-02

Completion date

Unknown

Last updated

2013-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Effect of erythromycin therapy on the inflammatory mediators in nasal discharge of chronic rhinosinusitis patients. MedDRA version: 9.1 Level: LLT Classification code 10009137 Term: Chronic sinusitis

Interventions

Trade Name: Erythromycin Tablets BP 250 mg Product Name: Erythromycin Pharmaceutical Form: Capsule* INN or Proposed INN: Erythromycin Concentration unit: mg milligram(s) Concentration type: equal Conc

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Patients with chronic rhinosinusitis who underwent a sinus operation in the last month prior to study registration - Age over 18 years Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Pregnancy - Women of reproductive age not using adequate contraception. The following are considered effective means of contraception: surgical sterilization or use of oral contraceptives, barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel, an IUD, or contraceptive hormone implant or patch - Significant renal or hepatic disorders - Cardiac arrhythmia - Cystic fibrosis - Primary ciliary dyskinesia - Immunodeficiency - Macrolide intolerance or allergy - Concomitant medication with drugs known to interact with macrolides

Design outcomes

Primary

Measure	Time frame
Main Objective: To study the effect of erythromycin therapy on the EPC and MPO concentrations in nasal discharge of chronic rhinosinusitis patients.;Secondary Objective: To study the effect of erythromycin therapy on: - IL-5 and IL-8 concentrations in nasal discharge of chronic rhinosinusitis patients - saccharin migration time - the results of the Sino-Nasal Outcome Test (SNOT-20 GAV) - the results of subjective nasal health (VAS) - nasal chemosensory performance (Sniffin´ Sticks) - the results of the nasal endoscopy - the results of the nasal swab;Primary end point(s): The changes of the EPC and MPO concentrations in nasal discharge of chronic rhinosinusitis patients after 12 weeks of erythromycin therapy.	—

Measure

Time frame

Main Objective: To study the effect of erythromycin therapy on the EPC and MPO concentrations in nasal discharge of chronic rhinosinusitis patients.;Secondary Objective: To study the effect of erythromycin therapy on: - IL-5 and IL-8 concentrations in nasal discharge of chronic rhinosinusitis patients - saccharin migration time - the results of the Sino-Nasal Outcome Test (SNOT-20 GAV) - the results of subjective nasal health (VAS) - nasal chemosensory performance (Sniffin´ Sticks) - the results of the nasal endoscopy - the results of the nasal swab;Primary end point(s): The changes of the EPC and MPO concentrations in nasal discharge of chronic rhinosinusitis patients after 12 weeks of erythromycin therapy.

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Countries

Germany

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026