FindTrial
Sign In

Aerosol Tobramycin 300 mg single dose in adult patient with cystic fibrosis

Aerosol Tobramycin 300 mg single dose in adult patient with cystic fibrosis: pilot study of antimicrobial activity

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2011-001821-26-IT
Enrollment
Unknown
Registered
2012-03-20
Start date
2011-10-18
Completion date
Unknown
Last updated
2012-08-28

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

Conditions

Adult patient with cystic fibrosis MedDRA version: 14.1 Level: PT Classification code 10011762 Term: Cystic fibrosis System Organ Class: 10010331 - Congenital, familial and genetic disorders

Interventions

Trade Name: BRAMITOB*NEBUL 28F 300MG/4ML Pharmaceutical Form: Nebuliser liquid INN or Proposed INN: TOBRAMYCIN CAS Number: 32986-56-4 Concentration unit: mg/g milligram(s)/gram Concentration type: equ

Sponsors

FONDAZIONE IRCCS CA' GRANDA OSPEDALE MAGGIORE POLICLINICO DI MILANO
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Out patient, both sexes, age 18-45. - diagnosys of cystic fibrosis - FEV1 >50% predicted - availability of sputum sample for microbiology - chest X ray negative for pneumonia and active tubercolosis - signed informed consent Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Hypersensibility or allergy to the study drug -use of systemic steroids (less than 2 weeks from the screening) - Pregnancy or lactation - partecipation in clinical trial with sperimental drug 4 weeks before enrollment

Design outcomes

Primary

MeasureTime frame
Main Objective: Evaluation of treatment efficacy in reducing bacterial load in sputum at visit 2 (day 7-9), visit 3 (day 14-16) and visit 4 (day 28-30);Secondary Objective: Evaluation of treatment efficacy in reducing inflammatory serum biomarkers at visit 2 (day 7-9), visit 3 (day 14-16) and visit 4 (day 28-30);Primary end point(s): Microbiological efficacy;Timepoint(s) of evaluation of this end point: visit 2,3,4—

Secondary

MeasureTime frame
Secondary end point(s): Reduction in inflammatory serum biomarkers;Timepoint(s) of evaluation of this end point: Visit 2,3,4—

Countries

Italy

Contacts

Public ContactUO Broncopneumologia

IRCCS CA GRANDA Osp. Magg Policlinico

francesco.blasi@unimi.it02/55033789

Outcome results

None listed

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