Personalized Variable Versus Fixed Dose Glucocorticoid Therapy in AECOPD
NCT ID: NCT02147015
Last Updated: 2020-10-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
248 participants
INTERVENTIONAL
2014-06-30
2018-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
Glucocorticoids
Antibiotics
Inhaled corticosteroid (ICS)
Long-Acting Muscarinic Antagonists(LAMA)
Short-acting beta2-agonist (SABA)
Physical treatments
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.
Glucocorticoids
Antibiotics
Inhaled corticosteroid (ICS)
Long-Acting Muscarinic Antagonists(LAMA)
Short-acting beta2-agonist (SABA)
Physical treatments
long-acting beta2-agonist (LABA)
Interventions
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Glucocorticoids
Antibiotics
Inhaled corticosteroid (ICS)
Long-Acting Muscarinic Antagonists(LAMA)
Short-acting beta2-agonist (SABA)
Physical treatments
long-acting beta2-agonist (LABA)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
40 Years
ALL
No
Sponsors
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Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
OTHER
Responsible Party
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Guoqiang Cao,MD
Vice Chair of Department of Respiratory Medicine
Principal Investigators
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Guoqiang Cao, Medical Doctor
Role: PRINCIPAL_INVESTIGATOR
Daping Hospital, Third Military Medical University
Locations
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Daping Hospital
Chongqing, Chongqing Municipality, China
Countries
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References
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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.
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, 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.
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.
Other Identifiers
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VIP
Identifier Type: -
Identifier Source: org_study_id