Tobramycin 300 mg Once-a-day (o.d.) Aerosol in Adults With Cystic Fibrosis

This study has been completed.
Sponsor:
Collaborator:
Chiesi Farmaceutici S.p.A.
Information provided by (Responsible Party):
Francesco Blasi, University of Milan
ClinicalTrials.gov Identifier:
NCT01608555
First received: May 28, 2012
Last updated: July 23, 2012
Last verified: July 2012
  Purpose

The study will include 10 adult patients with cystic fibrosis. The aim of the study is to evaluate whether Tobramycin 300 mg aerosol once-a-day for 28 days can reduce the bacterial load in the airways. Secondary end-point is the evaluation of variation in bacterial susceptibility during and at the end of study period.


Condition Intervention Phase
Cystic Fibrosis
Drug: tobramycin
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Tobramycin 300 mg o.d. Aerosol in in Adult Patients With Cystic Fibrosis: Pilot Study on Antimicrobial Activity

Resource links provided by NLM:


Further study details as provided by University of Milan:

Primary Outcome Measures:
  • Evaluation of bacterial load decrease [ Time Frame: day 7-9 vs day 1, day 14-16 vs day 7-9, day 28-30 vs day 14-26 ] [ Designated as safety issue: No ]
    Bacterial load in sputum will be evaluated during and at the end of treatment


Secondary Outcome Measures:
  • Evaluation of inflammatory serum biomarker [ Time Frame: day7-9 vs day 1, Day 14-16 vs day 7-9, Day 28-30 vs 14-16 ] [ Designated as safety issue: No ]
    Serum levels of biomarker (PCT) will be evaluated during and at the end of treatment

  • Evaluation of serum biomarker [ Time Frame: day7-9 vs day 1, Day 14-16 vs day 7-9, Day 28-30 vs 14-16 ] [ Designated as safety issue: No ]
    Evaluation of C-reactive protein levels during and at the end of treatment

  • Evaluation of serum biomarker [ Time Frame: day7-9 vs day 1, Day 14-16 vs day 7-9, Day 28-30 vs 14-16 ] [ Designated as safety issue: No ]
    Evaluation of KL6 levels during and at the end of treatment

  • evaluation of serum biomarker [ Time Frame: day7-9 vs day 1, Day 14-16 vs day 7-9, Day 28-30 vs 14-16 ] [ Designated as safety issue: No ]
    Evaluation of interleukin 6 during and at the end of treatment


Estimated Enrollment: 10
Study Start Date: January 2012
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: inhaled tobramycin once-a-day
Adult patients, with cystic fibrosis, requiring inhaled tobramycin prophylaxis. Patient will be treated with a single dose of 300 mg tobramycin od for 28 days.
Drug: tobramycin
inhaled tobramycin 300 mg single dose OD for 28 days
Other Name: Bramitob

Detailed Description:

Ten adult patients with cystic fibrosis will be enrolled in a stable phase and will received prophylaxis with aerosol of Tobramycin 300 mg once a day for 28 days.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Outpatients, male and female, age range 18-45 years
  • Diagnosis of cystic fibrosis
  • FEV1 >50% predicted.
  • sputum samples available
  • Chest x ray negative for pneumonia and tuberculosis
  • Informed consent

Exclusion Criteria:

  • Allergy to tobramycin
  • Use of systemic steroids in the previous 2 weeks
  • Pregnancy or breast feeding
  • Treatment with other experimental drug in the previous 3 months
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01608555

Locations
Italy
IRCCS Ospedale Maggiore Policlinico via F. Sforza 35
Milan, Italy, 20122
Sponsors and Collaborators
University of Milan
Chiesi Farmaceutici S.p.A.
Investigators
Principal Investigator: Giovanna Pizzamiglio, MD University of Milan Italy
  More Information

No publications provided

Responsible Party: Francesco Blasi, Professor of respiratory medicine, University of Milan
ClinicalTrials.gov Identifier: NCT01608555     History of Changes
Other Study ID Numbers: SP2, 2011-001821-26
Study First Received: May 28, 2012
Last Updated: July 23, 2012
Health Authority: Italy: Ethics Committee

Keywords provided by University of Milan:
cystic fibrosis
bacterial load
inhaled tobramycin

Additional relevant MeSH terms:
Cystic Fibrosis
Fibrosis
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Pathologic Processes
Tobramycin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014