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

• Register: EUCTR
• Last refreshed on: 28 August 2012
• Main ID: EUCTR2011-001821-26-IT
• Date of registration: 20/03/2012
• Prospective Registration: No
• Primary sponsor: FONDAZIONE IRCCS CA' GRANDA OSPEDALE MAGGIORE POLICLINICO DI MILANO
• Public title: Aerosol Tobramycin 300 mg single dose in adult patient with cystic fibrosis
• Scientific title: Aerosol Tobramycin 300 mg single dose in adult patient with cystic fibrosis: pilot study of antimicrobial activity
• Date of first enrolment: 18/10/2011
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-001821-26
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: Placebo: Other: Number of treatment arms in the trial: 1

Countries of recruitment

Italy

Contacts

• Name: UO Broncopneumologia
• Affiliation: IRCCS CA GRANDA Osp. Magg Policlinico

• Name: UO Broncopneumologia
• Affiliation: IRCCS CA GRANDA Osp. Magg Policlinico

Key inclusion & exclusion 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:
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


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

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

Intervention(s)

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: equal
Concentration number: 300-

Primary Outcome(s)

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)

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)

Timepoint(s) of evaluation of this end point: visit 2,3,4

Primary end point(s): Microbiological efficacy

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: Visit 2,3,4

Secondary end point(s): Reduction in inflammatory serum biomarkers

Secondary ID(s)

SP2

Source(s) of Monetary Support

CHIESI Farmaceutici SPA