Skip to main content
OpenTrials
Completed

NCT Number: NCT01608555

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cystic Fibrosis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Lung Diseases Pancreatic Diseases Respiratory Tract Diseases

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

IRCCS Ospedale Maggiore Policlinico via F. Sforza 35

Milan, 20122, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tobramycin

Drug

inhaled tobramycin 300 mg single dose OD for 28 days

Other names: Bramitob

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

    Serum levels of biomarker (PCT) will be evaluated during and at the end of treatment

  2. 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 C-reactive protein levels during and at the end of treatment

  3. 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 KL6 levels during and at the end of treatment

  4. 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 interleukin 6 during and at the end of treatment

Sponsors and collaborators

Lead sponsor

University of Milan

Other

Collaborators

  • Chiesi Farmaceutici S.p.A.

Registry information

Official study title

Tobramycin 300 mg o.d. Aerosol in in Adult Patients With Cystic Fibrosis: Pilot Study on Antimicrobial Activity

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
May 31, 2012
Registry last updated
Jul 24, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.