Personalized Variable Versus Fixed Dose Glucocorticoid Therapy in AECOPD

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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

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.

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.

Study Design

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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

MedlinePlus related topics: COPD Lung Diseases Steroids

U.S. FDA Resources

Arms and Interventions

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)

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

Outcome Measures

Primary Outcome Measures :

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 :

length of hospital stay [ Time Frame: 1 month ]

Other Outcome Measures:

Hospital costs [ Time Frame: up to 1 month ]

Eligibility Criteria

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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

Contacts and Locations

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

More Information

Publications:

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.

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.

Leuppi JD, Schuetz P, Bingisser R, Bodmer M, Briel M, Drescher T, Duerring U, Henzen C, Leibbrandt Y, Maier S, Miedinger D, Müller 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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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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

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