Cystic fibrosis MedDRA version: 9.1 Level: SOC Classification code 10038738
Conditions
Interventions
Trade Name: TOBI*NEBUL 56F 1D 300MG/5ML
Pharmaceutical Form: Nebuliser solution
INN or Proposed INN: Tobramycin
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 300-
Sponsors
AZIENDA OSPEDALIERA MEYER
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: CF patients with new P. aeruginosa colonisation Are the trial subjects under 18? yes 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) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: pulmonary exacerbation, chronic infection by Gram negative roads
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary aim of the study is to statistically compare, on a large sample of patients affected with CF and by means of a multicentre randomised trial, the efficacy of two types of eradication treatment (ciproflaxin per os and inhaled tobramycin compared to ciproflaxin per os and inhaled colistin) against a first P. aeruginosa infection.;Secondary Objective: microbiological and clinical evolution;Primary end point(s): to evaluate the effectiveness of 2 types of treatment | — |
Countries
Italy
Outcome results
None listed