Personalized Variable Versus Fixed Dose Glucocorticoid Therapy in AECOPD

Daping Hospital and the Research Institute of Surgery of the Third Military Medical University248 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

248

Conditions

Chronic Obstructive Pulmonary Disease

Interventions

GlucocorticoidsDRUG

AntibioticsDRUG

Inhaled corticosteroid (ICS)DRUG

Long-Acting Muscarinic Antagonists(LAMA)DRUG

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

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

Locations (1)

Daping Hospital

Chongqing, Chongqing Municipality, China

Outcomes

Primary Outcomes

Treatment failure

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)

Time frame: 6 months

Secondary Outcomes

length of hospital stay

Time frame: 1 month

Data from ClinicalTrials.gov

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