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

NCT ID: NCT01608555

Last Updated: 2012-07-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2012-07-31

Brief Summary

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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

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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

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Cystic Fibrosis

Keywords

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cystic fibrosis bacterial load inhaled tobramycin

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

tobramycin

Intervention Type DRUG

inhaled tobramycin 300 mg single dose OD for 28 days

Interventions

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tobramycin

inhaled tobramycin 300 mg single dose OD for 28 days

Intervention Type DRUG

Other Intervention Names

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Bramitob

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chiesi Farmaceutici S.p.A.

INDUSTRY

Sponsor Role collaborator

University of Milan

OTHER

Sponsor Role lead

Responsible Party

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Francesco Blasi

Professor of respiratory medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Giovanna Pizzamiglio, MD

Role: PRINCIPAL_INVESTIGATOR

University of Milan Italy

Locations

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IRCCS Ospedale Maggiore Policlinico via F. Sforza 35

Milan, , Italy

Site Status

Countries

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Italy

Other Identifiers

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2011-001821-26

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

SP2

Identifier Type: -

Identifier Source: org_study_id