Personalized Variable Versus Fixed Dose Glucocorticoid Therapy in AECOPD
Not Applicable
Completed
- Conditions
- Chronic Obstructive Pulmonary Disease
- Interventions
- Drug: GlucocorticoidsDrug: AntibioticsDrug: Inhaled corticosteroid (ICS)Drug: Long-Acting Muscarinic Antagonists(LAMA)Drug: Short-acting beta2-agonist (SABA)Other: Physical treatmentsDrug: long-acting beta2-agonist (LABA)
- Registration Number
- NCT02147015
- Lead Sponsor
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 248
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Personalized variable dose of glucocorticoids arm Glucocorticoids Use of personalized variable dose of glucocorticoids according to a rating scale starting from the first day of hospitalization for 5 days, together with other necessary treatments, including antibiotics, Inhaled corticosteroid (ICS), long-acting beta2-agonist (LABA), Long-Acting Muscarinic Antagonists(LAMA), short-acting beta2-agonist (SABA), and other physical treatments. Personalized variable dose of glucocorticoids arm Antibiotics Use of personalized variable dose of glucocorticoids according to a rating scale starting from the first day of hospitalization for 5 days, together with other necessary treatments, including antibiotics, Inhaled corticosteroid (ICS), long-acting beta2-agonist (LABA), Long-Acting Muscarinic Antagonists(LAMA), short-acting beta2-agonist (SABA), and other physical treatments. Personalized variable dose of glucocorticoids arm Inhaled corticosteroid (ICS) Use of personalized variable dose of glucocorticoids according to a rating scale starting from the first day of hospitalization for 5 days, together with other necessary treatments, including antibiotics, Inhaled corticosteroid (ICS), long-acting beta2-agonist (LABA), Long-Acting Muscarinic Antagonists(LAMA), short-acting beta2-agonist (SABA), and other physical treatments. Personalized variable dose of glucocorticoids arm Long-Acting Muscarinic Antagonists(LAMA) Use of personalized variable dose of glucocorticoids according to a rating scale starting from the first day of hospitalization for 5 days, together with other necessary treatments, including antibiotics, Inhaled corticosteroid (ICS), long-acting beta2-agonist (LABA), Long-Acting Muscarinic Antagonists(LAMA), short-acting beta2-agonist (SABA), and other physical treatments. Personalized variable dose of glucocorticoids arm Short-acting beta2-agonist (SABA) Use of personalized variable dose of glucocorticoids according to a rating scale starting from the first day of hospitalization for 5 days, together with other necessary treatments, including antibiotics, Inhaled corticosteroid (ICS), long-acting beta2-agonist (LABA), Long-Acting Muscarinic Antagonists(LAMA), short-acting beta2-agonist (SABA), and other physical treatments. Personalized variable dose of glucocorticoids arm Physical treatments Use of personalized variable dose of glucocorticoids according to a rating scale starting from the first day of hospitalization for 5 days, together with other necessary treatments, including antibiotics, Inhaled corticosteroid (ICS), long-acting beta2-agonist (LABA), Long-Acting Muscarinic Antagonists(LAMA), short-acting beta2-agonist (SABA), and other physical treatments. Personalized variable dose of glucocorticoids arm long-acting beta2-agonist (LABA) Use of personalized variable dose of glucocorticoids according to a rating scale starting from the first day of hospitalization for 5 days, together with other necessary treatments, including antibiotics, Inhaled corticosteroid (ICS), long-acting beta2-agonist (LABA), Long-Acting Muscarinic Antagonists(LAMA), short-acting beta2-agonist (SABA), and other physical treatments. Fixed dose of glucocorticoids arm Glucocorticoids Use of fixed term of glucocorticoids (40mg) starting from the first day of hospitalization for 5 days, together with other necessary treatments, including antibiotics, ICS, LABA, LAMA, SABA, and other physical treatments. Fixed dose of glucocorticoids arm Antibiotics Use of fixed term of glucocorticoids (40mg) starting from the first day of hospitalization for 5 days, together with other necessary treatments, including antibiotics, ICS, LABA, LAMA, SABA, and other physical treatments. Fixed dose of glucocorticoids arm Inhaled corticosteroid (ICS) Use of fixed term of glucocorticoids (40mg) starting from the first day of hospitalization for 5 days, together with other necessary treatments, including antibiotics, ICS, LABA, LAMA, SABA, and other physical treatments. Fixed dose of glucocorticoids arm Long-Acting Muscarinic Antagonists(LAMA) Use of fixed term of glucocorticoids (40mg) starting from the first day of hospitalization for 5 days, together with other necessary treatments, including antibiotics, ICS, LABA, LAMA, SABA, and other physical treatments. Fixed dose of glucocorticoids arm Short-acting beta2-agonist (SABA) Use of fixed term of glucocorticoids (40mg) starting from the first day of hospitalization for 5 days, together with other necessary treatments, including antibiotics, ICS, LABA, LAMA, SABA, and other physical treatments. Fixed dose of glucocorticoids arm Physical treatments Use of fixed term of glucocorticoids (40mg) starting from the first day of hospitalization for 5 days, together with other necessary treatments, including antibiotics, ICS, LABA, LAMA, SABA, and other physical treatments. Fixed dose of glucocorticoids arm long-acting beta2-agonist (LABA) Use of fixed term of glucocorticoids (40mg) starting from the first day of hospitalization for 5 days, together with other necessary treatments, including antibiotics, ICS, LABA, LAMA, SABA, and other physical treatments.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method length of hospital stay 1 month
Trial Locations
- Locations (1)
Daping Hospital
🇨🇳Chongqing, Chongqing, China