Chronic Obstructive Pulmonary Disease
Conditions
Keywords
Acute Exacerbations, Corticosteroids, Chronic Obstructive Pulmonary Disease, Doses
Brief summary
The hypothesis is that in acute exacerbated Chronic Obstructive Pulmonary Disease (AECOPD), personalized variable dose glucocorticoid treatment will result in superior clinical outcome when compared to fixed dose therapy.
Detailed description
Treatment with glucocorticoid for acute exacerbations of COPD results in the improvement of clinical outcomes. However, the optimal doses of glucocorticoid for each individual patient has not been determined. According to GOLD Report 2014, a dose of 40 mg prednisone per day for 5 days is recommended (Evidence B), although there are insufficient data to provide firm conclusions concerning the optimal duration of corticosteroid therapy of acute exacerbations of COPD. The purpose of the current study is to compare clinical outcomes of personalized or fixed dose of glucocorticoid in patients with acute exacerbations of COPD.
Interventions
DRUGGlucocorticoids
DRUGAntibiotics
DRUGLong-Acting Muscarinic Antagonists(LAMA)
DRUGShort-acting beta2-agonist (SABA)
OTHERPhysical treatments
DRUGlong-acting beta2-agonist (LABA)
Sponsors
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Exacerbation of COPD as defined by the presence of at least 2 of the following: change in baseline dyspnea, cough, or sputum quantity or purulence.
Exclusion criteria
* Signs of severe exacerbation (arterial pH \< 7.26 or PaCO2 \> 9.3 kPa) * History of asthma * Significant or unstable co-morbidity * Participated in another study 4 weeks before admission * Previously randomized to this study * Known hypersensitivity to prednisolone * Inability to give written informed consent * Radiological diagnosis of pneumonia * Estimated survival of less than 6 months due to severe comorbidity * Use of glucocorticoid within 1 month before admission
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment failure | 6 months | 1. death from any cause; 2. admission to the intensive care unit; 3. readmission to the hospital because of COPD 4. the necessity to intensify pharmacologic treatment during in-hospital (due to persistence of dyspnoea, bronchospasm, or worsening of other respiratory symptoms) |
Secondary
| Measure | Time frame |
|---|---|
| length of hospital stay | 1 month |
Other
| Measure | Time frame |
|---|---|
| Hospital costs | up to 1 month |
Countries
China
Outcome results
None listed