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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intravenous prednisolone | Drug | |||
| Oral prednisolone | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment failure defined as: death from any cause | ||
| admission to the intensive care unit | ||
| readmission to the hospital because of COPD | ||
| and the necessity to intensify pharmacologic treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in forced expiratory volume in 1 second (FEV1) | ||
| St. George's Respiratory Questionnaire (SGRQ) scores | ||
| Clinical COPD Questionnaire (CCQ) scores |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jan WK van den Berg, MD, PhD | Isala | Principal Investigator |
| Ynze P de Jong, MD | Isala | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Isala Klinieken | Zwolle | Overijssel | 8000 GM | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17646228 | Derived | de Jong YP, Uil SM, Grotjohan HP, Postma DS, Kerstjens HA, van den Berg JW. Oral or IV prednisolone in the treatment of COPD exacerbations: a randomized, controlled, double-blind study. Chest. 2007 Dec;132(6):1741-7. doi: 10.1378/chest.07-0208. Epub 2007 Jul 23. |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| ID | Term |
|---|---|
| D011239 | Prednisolone |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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| and length of hospital stay |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |