Pilot study to evaluate the local tollerability and efficacy of a new tobramycin 3% nasal spray formulation to reduce the bacterial density of Pseudomonas aeruginosa and/or Staphylococcus aureus, in patients affected by Cystic Fibrosis with rhinosinusal infection - ND

Conditions: Rhinosinusal infection by Pseudomonas a. e/o Staphylococcus a. in patients with Cystic Fibrosis
MedDRA version: 9.1Level: HLGTClassification code 10024970Term: Respiratory tract infections

Registration Number: EUCTR2007-003628-39-IT

Lead Sponsor: ECUPHARMA S.R.L.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

-Documented Cystic Fibrosis diagnosis based on the following: positive sweat test (chloride concentration = 60mEq/l or higher; two CF genotype mutations. -Documented nasal infection by Pseudomonas a. and/or Staphylococcus a. -Forced Expiratory Volume in one second (FEV1) that was at least 50% of the predicted value. - Age (6 to 22 years) -Compliant patients -Informed consent written provided by the patient and/or parent or legal tutor according to the current law.
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

-Hypersensitivity to aminoglycosides -Burkholderia cepacia cronic infection -Pregnancy and lactation -Septal deviation -Current and recurrent epistaxis -Rhinosinusal polypose -Endoscopic nasal surgery during the previous 6 months -Systemic antibiotic administration during the 30 days before the study or during it -Documented periodic or aperiodic allergic rhinitis

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the local tollerability of the tobramycin 3% nasal spray formulation;Secondary Objective: To evaluate the efficacy of the tobramycin 3% nasal spray formulation to reduce the bacterial density of the nasal swab. To evaluate the improvement of any symptoms related to the rhinosinusal infection.;Primary end point(s): Nasal local tollerability assessed by rhinofibroscopic examination at V0 and V2.

Secondary Outcome Measures