Cystic FibrosisPhase 4NCT01608555
Tobramycin 300 mg Once-a-day (o.d.) Aerosol in Adults With Cystic Fibrosis
A Phase 4 study testing tobramycin in people with Cystic Fibrosis, run by University of Milan at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- tobramycin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2012to Jul 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Tobramycin 300 mg o.d. Aerosol in in Adult Patients With Cystic Fibrosis: Pilot Study on Antimicrobial Activity
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.
Read the 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.
- Conditions
- Cystic Fibrosis
- Being tested
- tobramycin
- Keywords
- cystic fibrosis, bacterial load, inhaled tobramycin
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tobramycinDrug
Also called Bramitob
inhaled tobramycin 300 mg single dose OD for 28 days
| Study group | Role | What they receive |
|---|---|---|
| inhaled tobramycin once-a-day | Experimental | 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. Receives: Drug: tobramycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of bacterial load decrease
Bacterial load in sputum will be evaluated during and at the end of treatment
Measured: 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
Serum levels of biomarker (PCT) will be evaluated during and at the end of treatment
Measured: day7-9 vs day 1, Day 14-16 vs day 7-9, Day 28-30 vs 14-16
Evaluation of serum biomarker
Evaluation of C-reactive protein levels during and at the end of treatment
Measured: day7-9 vs day 1, Day 14-16 vs day 7-9, Day 28-30 vs 14-16
Evaluation of serum biomarker
Evaluation of KL6 levels during and at the end of treatment
Measured: day7-9 vs day 1, Day 14-16 vs day 7-9, Day 28-30 vs 14-16
evaluation of serum biomarker
Evaluation of interleukin 6 during and at the end of treatment
Measured: day7-9 vs day 1, Day 14-16 vs day 7-9, Day 28-30 vs 14-16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2012 (estimated)
- Study startJan 2012
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Milan
- Sponsor type
- University, hospital or other
- Collaborators
- Chiesi Farmaceutici S.p.A.
- Responsible party
- Principal investigator, Francesco Blasi, University of Milan
- Investigators
- Giovanna Pizzamiglio, MD, Principal investigator, University of Milan Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01608555
- Sponsor's protocol ID
- SP2
- Other IDs
- 2011-001821-26
- Status last verified
- Jul 2012
- First submitted
- 28 May 2012
- Last updated
- 24 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tobramycin 300 mg o.d. Aerosol in in Adult Patients With Cystic Fibrosis: Pilot Study on Antimicrobial Activity
- ClinicalTrials.gov ID
- NCT01608555
- Acronym / sponsor ID
- SP2
- Conditions
- Cystic Fibrosis
- Keywords
- cystic fibrosis, bacterial load, inhaled tobramycin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of MilanUniversity, hospital or other
- Collaborators
- Chiesi Farmaceutici S.p.A.
- Study start
- Jan 2012
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 31 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| inhaled tobramycin once-a-day | Experimental | Drug: tobramycinAdult patients, with cystic fibrosis, requiring inhaled tobramycin prophylaxis. Patient will be treated with a single dose of 300 mg tobramycin od for 28 days. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tobramycinAlso: Bramitobinhaled tobramycin 300 mg single dose OD for 28 days | Drug | inhaled tobramycin once-a-day |
Primary outcome
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
4 secondary outcomes
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
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 serum biomarker
Time frame: day7-9 vs day 1, Day 14-16 vs day 7-9, Day 28-30 vs 14-16
evaluation of serum biomarker
Time frame: day7-9 vs day 1, Day 14-16 vs day 7-9, Day 28-30 vs 14-16
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giovanna Pizzamiglio, MD principal investigator
University of Milan Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing tobramycin in people with Cystic Fibrosis, run by University of Milan at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2012; AzTrials last refreshed its copy on 7 Nov 2026.