Personalized Variable Versus Fixed Dose Glucocorticoid Therapy in AECOPD

Study Overview
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Brief Summary
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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
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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.

Official Title
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Personalized Variable Versus Fixed Dose Corticosteroids Therapy in Hospitalized Patients With Acute Exacerbations of Chronic Obstructive Pulmonary Disease

Conditions
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Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Drug: Glucocorticoids
* Drug: Antibiotics
* Drug: Inhaled corticosteroid (ICS)
* Drug: Long-Acting Muscarinic Antagonists(LAMA)
* Drug: Short-acting beta2-agonist (SABA)
* Other: Physical treatments
* Drug: long-acting beta2-agonist (LABA)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Personalized variable dose of glucocorticoids arm<br>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. | Drug: Glucocorticoids<br> <br> * Other names: methylprednisolone;Drug: Antibiotics<br> <br> Drug: Inhaled corticosteroid (ICS)<br> <br> Drug: Long-Acting Muscarinic Antagonists(LAMA)<br> <br> Drug: Short-acting beta2-agonist (SABA)<br> <br> Other: Physical treatments<br> <br> Drug: long-acting beta2-agonist (LABA)<br> <br> |
| Other: Fixed dose of glucocorticoids arm<br>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. | Drug: Glucocorticoids<br> <br> * Other names: methylprednisolone;Drug: Antibiotics<br> <br> Drug: Inhaled corticosteroid (ICS)<br> <br> Drug: Long-Acting Muscarinic Antagonists(LAMA)<br> <br> Drug: Short-acting beta2-agonist (SABA)<br> <br> Other: Physical treatments<br> <br> Drug: long-acting beta2-agonist (LABA)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment failure | death from any cause; admission to the intensive care unit; readmission to the hospital because of COPD the necessity to intensify pharmacologic treatment during in-hospital (due to persistence of dyspnoea, bronchospasm, or worsening of other respiratory symptoms) | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| length of hospital stay |  | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute Exacerbations, Corticosteroids, Chronic Obstructive Pulmonary Disease, Doses