Hospitalized male and female patients aged ≥ 18 years, suffering of Cystic Fibrosis.

Cystic Fibrosis

Teicoplanin Sandoz administered by inhalation (aerosol).

Teicoplanin Sandoz 200 mg powder and solvent for solution for injection or infusion or oral solution.

Centro Ricerche Cliniche di Verona - Azienda Ospedaliera Universitaria Integrata di Verona

Open-label, Dose-escalation Study to Evaluate the Pharmacokinetics of Inhaled Teicoplanin in Cystic Fibrosis Patients

An Open-label, Dose-escalation Study to Evaluate the Pharmacokinetics of Inhaled Teicoplanin in Cystic Fibrosis Patients

Measurement of the concentration (expressed as mg/L) of Teicoplanin in the sputum of patients suffering of Cystic Fibrosis after a single inhalation of 150 mg at scheduled time points after first inhalation: 0 hours, 0.5 hours, 2 hours, 4 hours, 8 hours, 12 hours, 24 hours. The evaluation of Teicoplanin pharmacokinetics will include calculation of Cmax (mg/L), Tmax (hours) and AUC0-12 h (μg/mL*h) starting from the obtained concentration (mg/L). In case a value of AUC0-12 h above 300 μg/mL*h will not be achieved with the first dosage inhalation of Teicoplanin, up to two additional inhalations with different dosages will be foreseen and the same time points will be measured for subsequent inhalations.

Measurement of the concentration (expressed as mg/L) of Teicoplanin in the blood of patients suffering of Cystic Fibrosis after a single inhalation of 150 mg at scheduled time points after first inhalation: 0 hours, 0.5 hours, 2 hours, 4 hours, 8 hours, 12 hours, 24 hours. The evaluation of Teicoplanin pharmacokinetics will include calculation of Cmax (mg/L), Tmax (hours) and AUC0-12 h (μg/mL*h) starting from the obtained concentration (mg/L). In case a value of AUC0-12 h above 300 μg/mL*h will not be achieved with the first dosage inhalation of Teicoplanin, up to two additional inhalations with different dosages will be foreseen and the same time points will be measured for subsequent inhalations.

Measurement of the concentration (expressed as mg/L) of Teicoplanin in the urine of patients suffering of Cystic Fibrosis after a single inhalation of 150 mg at scheduled time intervals after first inhalation: 0 hours, 0 - 4 hours, 4 - 12 hours, 12 - 24 hours. The evaluation of Teicoplanin pharmacokinetics will include calculation of Cmax (mg/L), Tmax (hours) and AUC0-12 h (μg/mL*h) starting from the obtained concentration (mg/L). In case a value of AUC0-12 h above 300 μg/mL*h will not be achieved with the first dosage inhalation of Teicoplanin, up to two additional inhalations with different dosages will be foreseen and the same time intervals will be measured for subsequent inhalations.

Comparison between the concentration (expressed as mg/L) of Teicoplanin measured in the sputum, blood and urine of patients suffering of Cystic Fibrosis after a single inhalation of 150 mg versus additional dosage(s) of Teicoplanin, in case a value of AUC0-12 h above 300 μg/mL*h will not be achieved with the first dosage inhalation of Teicoplanin.

Measurement of any changes (as %) in the Forced Expiratory Volume in the 1st second (FEV1) measured 30 minutes before and 30 and 60 minutes after a single inhalation of 150 mg of inhaled Teicoplanin. In case of FEV1 reduction > 5% in comparison to baseline the FEV1 will be measured also after 120 minutes from inhalation. In case a value of AUC0-12 h above 300 μg/mL*h will not be achieved with the first dosage inhalation of Teicoplanin, up to two additional inhalations with different dosages will be foreseen and the same time points will be measured for subsequent inhalations.

Measurement of any changes (as %) in the blood oxigen saturation measured 30 minutes before and 30 minutes + 4 hours after a single inhalation of 150 mg of inhaled Teicoplanin. In case a value of AUC0-12 h above 300 μg/mL*h will not be achieved with the first dosage inhalation of Teicoplanin, up to two additional inhalations with different dosages will be foreseen and the same time points will be measured for subsequent inhalations.

Evaluation of the number, rate and characteristics of the adverse events occurring to CF patients treated with inhaled Teicoplanin, as recorded in the Case Report Form. Any adverse events occurring during the inhalation visits will be also evaluated from a Tolerability point of view.

Neupharma Srl

Sintesi Research Srl

Aptuit Srl

Pari Pharma GmbH

Centro Ricerche Cliniche di Verona

Prospective, single-arm, exploratory, open-label, dose-escalation study evaluating the pharmacokinetics of inhaled Teicoplanin in Cystic Fibrosis patients.

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Open-label, Dose-escalation Study to Evaluate the Pharmacokinetics of Inhaled Teicoplanin in Cystic Fibrosis Patients

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