Back to resultsTobramycin 300 mg Once-a-day (o.d.) Aerosol in Adults With Cystic Fibrosis
Primary Purpose
Cystic Fibrosis
Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
tobramycin
Sponsored by
About this trial
This is an interventional treatment trial for Cystic Fibrosis focused on measuring cystic fibrosis, bacterial load, inhaled tobramycin
Eligibility 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
Sites / Locations
- IRCCS Ospedale Maggiore Policlinico via F. Sforza 35
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
inhaled tobramycin once-a-day
Arm Description
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.
Outcomes
Primary Outcome Measures
Evaluation of bacterial load decrease
Bacterial load in sputum will be evaluated during and at the end of treatment
Secondary Outcome Measures
Evaluation of inflammatory serum biomarker
Serum levels of biomarker (PCT) will be evaluated during and at the end of treatment
Evaluation of serum biomarker
Evaluation of C-reactive protein levels during and at the end of treatment
Evaluation of serum biomarker
Evaluation of KL6 levels during and at the end of treatment
evaluation of serum biomarker
Evaluation of interleukin 6 during and at the end of treatment
Full Information
NCT ID
NCT01608555
First Posted
May 28, 2012
Last Updated
July 23, 2012
Sponsor
University of Milan
Collaborators
Chiesi Farmaceutici S.p.A.
1. Study Identification
Unique Protocol Identification Number
NCT01608555
Brief Title
Tobramycin 300 mg Once-a-day (o.d.) Aerosol in Adults With Cystic Fibrosis
Official Title
Tobramycin 300 mg o.d. Aerosol in in Adult Patients With Cystic Fibrosis: Pilot Study on Antimicrobial Activity
Study Type
Interventional
2. Study Status
Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
July 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Milan
Collaborators
Chiesi Farmaceutici S.p.A.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis
Keywords
cystic fibrosis, bacterial load, inhaled tobramycin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
inhaled tobramycin once-a-day
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
tobramycin
Other Intervention Name(s)
Bramitob
Intervention Description
inhaled tobramycin 300 mg single dose OD for 28 days
Primary Outcome Measure Information:
Title
Evaluation of bacterial load decrease
Description
Bacterial load in sputum will be evaluated during and at the end of treatment
Time Frame
day 7-9 vs day 1, day 14-16 vs day 7-9, day 28-30 vs day 14-26
Secondary Outcome Measure Information:
Title
Evaluation of inflammatory serum biomarker
Description
Serum levels of biomarker (PCT) will be evaluated during and at the end of treatment
Time Frame
day7-9 vs day 1, Day 14-16 vs day 7-9, Day 28-30 vs 14-16
Title
Evaluation of serum biomarker
Description
Evaluation of C-reactive protein levels during and at the end of treatment
Time Frame
day7-9 vs day 1, Day 14-16 vs day 7-9, Day 28-30 vs 14-16
Title
Evaluation of serum biomarker
Description
Evaluation of KL6 levels during and at the end of treatment
Time Frame
day7-9 vs day 1, Day 14-16 vs day 7-9, Day 28-30 vs 14-16
Title
evaluation of serum biomarker
Description
Evaluation of interleukin 6 during and at the end of treatment
Time Frame
day7-9 vs day 1, Day 14-16 vs day 7-9, Day 28-30 vs 14-16
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giovanna Pizzamiglio, MD
Organizational Affiliation
University of Milan Italy
Official's Role
Principal Investigator
Facility Information:
Facility Name
IRCCS Ospedale Maggiore Policlinico via F. Sforza 35
City
Milan
ZIP/Postal Code
20122
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
Tobramycin 300 mg Once-a-day (o.d.) Aerosol in Adults With Cystic Fibrosis
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