Tobramycin 300 mg Once-a-day (o.d.) Aerosol in Adults With Cystic Fibrosis
Tobramycin 300 mg o.d. Aerosol in in Adult Patients With Cystic Fibrosis: Pilot Study on Antimicrobial Activity
2 other identifiers
interventional
10
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Jan 2012
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2012
CompletedFirst Submitted
Initial submission to the registry
May 28, 2012
CompletedFirst Posted
Study publicly available on registry
May 31, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2012
CompletedJuly 24, 2012
July 1, 2012
6 months
May 28, 2012
July 23, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Evaluation of bacterial load decrease
Bacterial load in sputum will be evaluated during and at the end of treatment
day 7-9 vs day 1, day 14-16 vs day 7-9, day 28-30 vs day 14-26
Secondary Outcomes (4)
Evaluation of inflammatory serum biomarker
day7-9 vs day 1, Day 14-16 vs day 7-9, Day 28-30 vs 14-16
Evaluation of serum biomarker
day7-9 vs day 1, Day 14-16 vs day 7-9, Day 28-30 vs 14-16
Evaluation of serum biomarker
day7-9 vs day 1, Day 14-16 vs day 7-9, Day 28-30 vs 14-16
evaluation of serum biomarker
day7-9 vs day 1, Day 14-16 vs day 7-9, Day 28-30 vs 14-16
Study Arms (1)
inhaled tobramycin once-a-day
EXPERIMENTALAdult patients, with cystic fibrosis, requiring inhaled tobramycin prophylaxis. Patient will be treated with a single dose of 300 mg tobramycin od for 28 days.
Interventions
inhaled tobramycin 300 mg single dose OD for 28 days
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Milanlead
- Chiesi Farmaceutici S.p.A.collaborator
Study Sites (1)
IRCCS Ospedale Maggiore Policlinico via F. Sforza 35
Milan, 20122, Italy
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Giovanna Pizzamiglio, MD
University of Milan Italy
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of respiratory medicine
Study Record Dates
First Submitted
May 28, 2012
First Posted
May 31, 2012
Study Start
January 1, 2012
Primary Completion
July 1, 2012
Study Completion
July 1, 2012
Last Updated
July 24, 2012
Record last verified: 2012-07