chronic bronchitis COPD
Conditions
Interventions
These patients will be randomized into:
1.Treatment with Levofloxacin inhalation twice daily 240 mg for 28 days
administered via PARI LC PLUS jet nebuliser and oral antibiotics during 7 days
Or
2.S
Sponsors
Amphia Ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - COPD patients, who were 18 years or older, hospitalized with an exacerbation for which they need to receive corticosteroids and antibiotic treatment. - COPD patients with 1 or more exacerbations in the previous year before admission for which they received steroids and/or antibiotic treatment. - FEV1 less than 80% of predicted, FEV1 to FVC ratio < 0.7 and a history of smoking - Procalcitonin value >0.25 µg/L or CRP value > 50 mg/L
Exclusion criteria
Exclusion criteria: - History of fluoroquinolon hypersensitivity or adverse reaction to inhaled fluoroquinolones - A history of other significant respiratory diseases (e.g. asthma, cystic fibrosis), the presence of bronchiectasis assessed by computed tomography (CT), pregnant or lactating women, malignancy of any kind for which the subject received treatment or was being monitored as part of follow up after treatment,
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| time to next exacerbation, mean number of exacerbations in 6 month follow-up | — |
Secondary
| Measure | Time frame |
|---|---|
| Number of exacerbations - Number of hospital admissions in 6 months - Bacterial eradication measured by 3 different negative sputum cultures during 6 months - Lung function: FEV1; FVC - Quality of life | — |
Countries
Netherlands
Outcome results
None listed