Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2011-001821-26 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Chiesi Farmaceutici S.p.A. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tobramycin | Drug | inhaled tobramycin 300 mg single dose OD for 28 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Evaluation of serum biomarker |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Giovanna Pizzamiglio, MD | University of Milan Italy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS Ospedale Maggiore Policlinico via F. Sforza 35 | Milan | 20122 | Italy |
Not provided
| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D014031 | Tobramycin |
| ID | Term |
|---|---|
| D009328 | Nebramycin |
| D007612 | Kanamycin |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 |
| 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 |
| 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 |
| D030342 |
| Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |
| Carbohydrates |