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Completed

NCT Number: NCT02147015

Personalized Variable Versus Fixed Dose Glucocorticoid Therapy in AECOPD

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.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Daping Hospital

Chongqing, Chongqing Municipality, 400042, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Glucocorticoids

Drug

Other names: methylprednisolone

Antibiotics

Drug

Inhaled corticosteroid (ICS)

Drug

Long-Acting Muscarinic Antagonists(LAMA)

Drug

Short-acting beta2-agonist (SABA)

Drug

Physical treatments

Other

long-acting beta2-agonist (LABA)

Drug

Primary outcomes

  1. Treatment failure

    Time frame: 6 months

    • 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)

Secondary outcomes

  1. length of hospital stay

    Time frame: 1 month

Other outcomes

  1. Hospital costs

    Time frame: up to 1 month

Sponsors and collaborators

Lead sponsor

Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2017
Study completion
2018
First posted
May 26, 2014
Registry last updated
Oct 26, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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