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

Sponsor
University of Milan (Other)
Overall Status
Completed
CT.gov ID
NCT01608555
Collaborator
Chiesi Farmaceutici S.p.A. (Industry)
10
Enrollment
1
Location
1
Arm
6
Duration (Months)
1.7
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
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.

Study Design

Study Type:
Interventional
Anticipated 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 :
Jan 1, 2012
Actual Primary Completion Date :
Jul 1, 2012
Actual Study Completion Date :
Jul 1, 2012

Arms and Interventions

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 Names:
  • Bramitob

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Evaluation of bacterial load decrease [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 [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 [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 [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 [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 IRCCS Ospedale Maggiore Policlinico via F. Sforza 35 Milan Italy 20122

    Sponsors and Collaborators

    • University of Milan
    • Chiesi Farmaceutici S.p.A.

    Investigators

    • Principal Investigator: Giovanna Pizzamiglio, MD, University of Milan Italy

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Francesco Blasi, Professor of respiratory medicine, University of Milan
    ClinicalTrials.gov Identifier:
    NCT01608555
    Other Study ID Numbers:
    • SP2
    • 2011-001821-26
    First Posted:
    May 31, 2012
    Last Update Posted:
    Jul 24, 2012
    Last Verified:
    Jul 1, 2012
    Keywords provided by Francesco Blasi, Professor of respiratory medicine, University of Milan
    cystic fibrosis
    bacterial load
    inhaled tobramycin
    Additional relevant MeSH terms:
    Cystic Fibrosis
    Fibrosis
    Tobramycin

    Study Results

    No Results Posted as of Jul 24, 2012