Personalized Variable Versus Fixed Dose Glucocorticoid Therapy in AECOPD

October 22, 2020 updated by: Guoqiang Cao,MD, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

248

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Chongqing
      • Chongqing, Chongqing, China, 400042
        • Daping Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Personalized variable dose of glucocorticoids arm
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: Antibiotics
Drug: Glucocorticoids
Other Names:
  • methylprednisolone
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)
Other: Fixed dose of glucocorticoids arm
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: Antibiotics
Drug: Glucocorticoids
Other Names:
  • methylprednisolone
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment failure
Time Frame: 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)
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
length of hospital stay
Time Frame: 1 month
1 month

Other Outcome Measures

Outcome Measure
Time Frame
Hospital costs
Time Frame: up to 1 month
up to 1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Investigators

  • Principal Investigator: Guoqiang Cao, Medical Doctor, Daping Hospital, Third Military Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2014

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

April 1, 2018

Study Registration Dates

First Submitted

May 22, 2014

First Submitted That Met QC Criteria

May 23, 2014

First Posted (Estimate)

May 26, 2014

Study Record Updates

Last Update Posted (Actual)

October 26, 2020

Last Update Submitted That Met QC Criteria

October 22, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VIP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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