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

Cystic Fibrosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01608555
• Other study ID #: SP2
• Secondary ID: 2011-001821-26
• Status: Completed
• Phase: Phase 4
• First received: May 28, 2012
• Last updated: July 23, 2012
• Start date: January 2012
• Est. completion date: July 2012

Study information

• Verified date: July 2012
• Source: University of Milan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

Drug:
• tobramycin
inhaled tobramycin 300 mg single dose OD for 28 days

Locations

Country	Name	City	State
Italy	IRCCS Ospedale Maggiore Policlinico via F. Sforza 35	Milan

Sponsors (2)

Lead Sponsor	Collaborator
University of Milan	Chiesi Farmaceutici S.p.A.

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Evaluation of inflammatory serum biomarker	Serum levels of biomarker (PCT) will be evaluated during and at the end of treatment	day7-9 vs day 1, Day 14-16 vs day 7-9, Day 28-30 vs 14-16	No
Secondary	Evaluation of serum biomarker	Evaluation of C-reactive protein levels during and at the end of treatment	day7-9 vs day 1, Day 14-16 vs day 7-9, Day 28-30 vs 14-16	No
Secondary	Evaluation of serum biomarker	Evaluation of KL6 levels during and at the end of treatment	day7-9 vs day 1, Day 14-16 vs day 7-9, Day 28-30 vs 14-16	No
Secondary	evaluation of serum biomarker	Evaluation of interleukin 6 during and at the end of treatment	day7-9 vs day 1, Day 14-16 vs day 7-9, Day 28-30 vs 14-16	No