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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01608555
First Posted: May 31, 2012
Last Update Posted: July 24, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Chiesi Farmaceutici S.p.A.
Information provided by (Responsible Party):
Francesco Blasi, University of Milan
  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
Intervention Model: Single Group Assignment
Masking: None (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 Francesco Blasi, 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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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 ( EudraCT Number )
First Submitted: May 28, 2012
First Posted: May 31, 2012
Last Update Posted: July 24, 2012
Last Verified: July 2012

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

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