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

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ClinicalTrials.gov Identifier: NCT01608555
Recruitment Status : Completed
First Posted : May 31, 2012
Last Update Posted : July 24, 2012
Sponsor:
Collaborator:
Chiesi Farmaceutici S.p.A.
Information provided by (Responsible Party):
Francesco Blasi, University of Milan

Brief Summary:
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 or disease Intervention/treatment Phase
Cystic Fibrosis Drug: tobramycin Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
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
Study Start Date : January 2012
Actual Primary Completion Date : July 2012
Actual Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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 :
  1. 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

  2. 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

  3. 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

  4. 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



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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

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

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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 Posted: May 31, 2012    Key Record Dates
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:
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Anti-Bacterial Agents
Anti-Infective Agents
Cystic Fibrosis
Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Tobramycin