Bronchiectasis
Conditions
Brief summary
Proportion of sputum/airway culture negativity (=3 consecutively negative sputum/airway cultures) for PA 28 weeks after randomisation
Detailed description
Change in PA (semi-quantitative) in sputum from baseline to Day 29 of treatment, Rate of pulmonary exacerbations in 28 weeks after randomisation, Rate of severe exacerbations (hospitalizations) in 28 weeks after randomisation, Time to first pulmonary exacerbation after start of treatment, Change from baseline in respiratory symptom domain of the SGRQ ountil 28 weeks after randomization, Change from baseline in quality of life measured by SGRQ until 28 weeks after randomization, Change from baseline in quality of life measured by QOL-B until 28 weeks after randomization, Change from baseline on change in ppFEV1, Change in antibiotic susceptibility in isolated sputum PA until 28 weeks after randomization
Interventions
DRUGColiFin® 2 Millionen I.E. Pulver zur Herstellung
einer Lösung für einen Vernebler
Sponsors
Philipps-Universitaet Marburg
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of sputum/airway culture negativity (=3 consecutively negative sputum/airway cultures) for PA 28 weeks after randomisation | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in PA (semi-quantitative) in sputum from baseline to Day 29 of treatment, Rate of pulmonary exacerbations in 28 weeks after randomisation, Rate of severe exacerbations (hospitalizations) in 28 weeks after randomisation, Time to first pulmonary exacerbation after start of treatment, Change from baseline in respiratory symptom domain of the SGRQ ountil 28 weeks after randomization, Change from baseline in quality of life measured by SGRQ until 28 weeks after randomization, Change from baseline in quality of life measured by QOL-B until 28 weeks after randomization, Change from baseline on change in ppFEV1, Change in antibiotic susceptibility in isolated sputum PA until 28 weeks after randomization | — |
Countries
Germany
Outcome results
None listed