Chronic Obstructive Pulmonary Disease
Conditions
Keywords
COPD, Exacerbations, Corticosteroids, Oral, Intravenous, Chronic Obstructive Pulmonary Disease (COPD)
Brief summary
Treatment with systemic corticosteroids for acute exacerbations of COPD results in the improvement of clinical outcomes. The optimal route of administration has not been rigorously studied in COPD. Upon hospitalization, corticosteroids are administered intravenously in many hospitals. Oral administration is more convenient, though, because there is no need for intravenous access, less personnel is required for starting and monitoring therapy, and material costs are smaller. The investigators hypothesized that oral administration is not inferior to intravenous administration of prednisolone in the treatment of patients hospitalized for an acute exacerbation of COPD.
Interventions
Sponsors
Isala
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Inclusion criteria
* Exacerbation of COPD (at least Global Initiative for Chronic Obstructive Lung Disease \[GOLD\] severity stage II) * Smoking history of \> 10 pack years
Exclusion criteria
* Signs of severe exacerbation (arterial pH \< 7.26 or pCO2 \> 9.3 kPa) * History of asthma * Significant or unstable co-morbidity * Participated in another study 4 weeks before admission * Previously randomized to this study * Findings on chest radiography other than those fitting with signs of COPD * Known hypersensitivity to prednisolone * Non-compliant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| and the necessity to intensify pharmacologic treatment | — |
| Treatment failure defined as: death from any cause | — |
| admission to the intensive care unit | — |
| readmission to the hospital because of COPD | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in forced expiratory volume in 1 second (FEV1) | — |
| St. George's Respiratory Questionnaire (SGRQ) scores | — |
| Clinical COPD Questionnaire (CCQ) scores | — |
| and length of hospital stay | — |
Countries
Netherlands
Outcome results
None listed