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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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Digestive System Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Lung Diseases
Pancreatic Diseases
Pathologic Processes
Respiratory Tract Diseases
Tobramycin
Anti-Bacterial Agents
Anti-Infective Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014