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Personalized Variable Versus Fixed Dose Glucocorticoid Therapy in AECOPD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02147015
Recruitment Status : Completed
First Posted : May 26, 2014
Last Update Posted : October 26, 2020
Sponsor:
Information provided by (Responsible Party):
Guoqiang Cao,MD, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

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.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease 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) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 248 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Personalized Variable Versus Fixed Dose Corticosteroids Therapy in Hospitalized Patients With Acute Exacerbations of Chronic Obstructive Pulmonary Disease
Actual Study Start Date : June 2014
Actual Primary Completion Date : December 2017
Actual Study Completion Date : April 2018

Resource links provided by the National Library of Medicine


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: Glucocorticoids
Other Name: methylprednisolone

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)
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: Glucocorticoids
Other Name: methylprednisolone

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)



Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. length of hospital stay [ Time Frame: 1 month ]

Other Outcome Measures:
  1. Hospital costs [ Time Frame: up to 1 month ]


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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02147015


Locations
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China, Chongqing
Daping Hospital
Chongqing, Chongqing, China, 400042
Sponsors and Collaborators
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Investigators
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Principal Investigator: Guoqiang Cao, Medical Doctor Daping Hospital, Third Military Medical University
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Guoqiang Cao,MD, Vice Chair of Department of Respiratory Medicine, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
ClinicalTrials.gov Identifier: NCT02147015    
Other Study ID Numbers: VIP
First Posted: May 26, 2014    Key Record Dates
Last Update Posted: October 26, 2020
Last Verified: October 2020
Keywords provided by Guoqiang Cao,MD, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University:
Acute Exacerbations
Corticosteroids
Chronic Obstructive Pulmonary Disease
Doses
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Anti-Bacterial Agents
Methylprednisolone
Glucocorticoids
Cholinergic Agents
Muscarinic Antagonists
Anti-Infective Agents
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents
Protective Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Cholinergic Antagonists