E84.0 B96.5
Conditions
Interventions
Group 1: Sequential therapy with Bramitob and Colistin
Group 2: Monotherapy with Bramitob
Group 3: Monotherapy with Colistin
Sponsors
Chiesi GmbH
Eligibility
Sex/Gender
All
Age
6 Years to No maximum
Inclusion criteria
Inclusion criteria: Established CF diagnosis (sweat chloride test or gentic proof); age = 6 years; chronic lung infection with Pseudomonas aeruginosa; patients requiring more therapeutic escalation based on worsening of symptoms or of lung function; bacteriological susceptibilty of Pseudomas against tobramycin- and/or colistin; normal kidney function; normal hearing.
Exclusion criteria
Exclusion criteria: Known hypersensitivity/allergy against Colistin or other aminogycosids. Pregnancy or breast-feeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency of specific adverse reactions associated with inhalation therapy with Bramitob® (monotherapy) or Colistin (monotherapy) or Bramitob® and Colistin (sequential therapy) such as bronchial obstruction, cough, or hoarseness at baseline and after 6 months of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Change of pulmonary symptoms after 3 months and 6 months of treatment compared to baseline - Number of Exazerbation within 3 months and 6 months of treatment -Need for intravenous antibiotics within 3 months and 6 months of treatment - Forced expiratory volume in 1 second (FEV1) over 6 months of treatment | — |
Countries
Germany
Contacts
Public ContactDagmar Wagenseil
Chiesi GmbH
Outcome results
None listed