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Personalized Variable Versus Fixed Dose Glucocorticoid Therapy in AECOPD

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Glucocorticoids
Antibiotics
Inhaled corticosteroid (ICS)
Long-Acting Muscarinic Antagonists(LAMA)
Short-acting beta2-agonist (SABA)
Physical treatments
long-acting beta2-agonist (LABA)
Sponsored by
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring Acute Exacerbations, Corticosteroids, Chronic Obstructive Pulmonary Disease, Doses

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Daping Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Personalized variable dose of glucocorticoids arm

Fixed dose of glucocorticoids arm

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

length of hospital stay

Full Information

First Posted
May 22, 2014
Last Updated
October 22, 2020
Sponsor
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT02147015
Brief Title
Personalized Variable Versus Fixed Dose Glucocorticoid Therapy in AECOPD
Official Title
Personalized Variable Versus Fixed Dose Corticosteroids Therapy in Hospitalized Patients With Acute Exacerbations of Chronic Obstructive Pulmonary Disease
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
June 2014 (Actual)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
April 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
Acute Exacerbations, Corticosteroids, Chronic Obstructive Pulmonary Disease, Doses

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
248 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Personalized variable dose of glucocorticoids arm
Arm Type
Experimental
Arm Description
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.
Arm Title
Fixed dose of glucocorticoids arm
Arm Type
Other
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Glucocorticoids
Other Intervention Name(s)
methylprednisolone
Intervention Type
Drug
Intervention Name(s)
Antibiotics
Intervention Type
Drug
Intervention Name(s)
Inhaled corticosteroid (ICS)
Intervention Type
Drug
Intervention Name(s)
Long-Acting Muscarinic Antagonists(LAMA)
Intervention Type
Drug
Intervention Name(s)
Short-acting beta2-agonist (SABA)
Intervention Type
Other
Intervention Name(s)
Physical treatments
Intervention Type
Drug
Intervention Name(s)
long-acting beta2-agonist (LABA)
Primary Outcome Measure Information:
Title
Treatment failure
Description
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)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
length of hospital stay
Time Frame
1 month
Other Pre-specified Outcome Measures:
Title
Hospital costs
Time Frame
up to 1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guoqiang Cao, Medical Doctor
Organizational Affiliation
Daping Hospital, Third Military Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Daping Hospital
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400042
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
10465169
Citation
Davies L, Angus RM, Calverley PM. Oral corticosteroids in patients admitted to hospital with exacerbations of chronic obstructive pulmonary disease: a prospective randomised controlled trial. Lancet. 1999 Aug 7;354(9177):456-60. doi: 10.1016/s0140-6736(98)11326-0.
Results Reference
background
PubMed Identifier
20551406
Citation
Lindenauer PK, Pekow PS, Lahti MC, Lee Y, Benjamin EM, Rothberg MB. Association of corticosteroid dose and route of administration with risk of treatment failure in acute exacerbation of chronic obstructive pulmonary disease. JAMA. 2010 Jun 16;303(23):2359-67. doi: 10.1001/jama.2010.796.
Results Reference
background
PubMed Identifier
23695200
Citation
Leuppi JD, Schuetz P, Bingisser R, Bodmer M, Briel M, Drescher T, Duerring U, Henzen C, Leibbrandt Y, Maier S, Miedinger D, Muller B, Scherr A, Schindler C, Stoeckli R, Viatte S, von Garnier C, Tamm M, Rutishauser J. Short-term vs conventional glucocorticoid therapy in acute exacerbations of chronic obstructive pulmonary disease: the REDUCE randomized clinical trial. JAMA. 2013 Jun 5;309(21):2223-31. doi: 10.1001/jama.2013.5023.
Results Reference
background
PubMed Identifier
34023318
Citation
Li L, Zhao N, Ma X, Sun F, He B, Qin Z, Wu K, Wang X, Zhao Q, Zhang S, Nie N, Luo D, Sun B, Shen Y, He Y, Wen F, Zheng J, Jones P, Cao G. Personalized Variable vs Fixed-Dose Systemic Corticosteroid Therapy in Hospitalized Patients With Acute Exacerbations of COPD: A Prospective, Multicenter, Randomized, Open-Label Clinical Trial. Chest. 2021 Nov;160(5):1660-1669. doi: 10.1016/j.chest.2021.05.024. Epub 2021 May 21.
Results Reference
derived

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Personalized Variable Versus Fixed Dose Glucocorticoid Therapy in AECOPD

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