Personalized Variable Versus Fixed Dose Glucocorticoid Therapy in AECOPD

NCT02147015 | Completed

• 1 other identifier: VIP
• Study Type: interventional
• Target: 248
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Acute Exacerbations; Corticosteroids; Chronic Obstructive Pulmonary Disease; Doses

Outcome Measures

Primary Outcomes (1)

• Treatment failure

  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 Outcomes (1)

• length of hospital stay

  1 month

Other Outcomes (1)

• Hospital costs

  up to 1 month

Study Arms (2)

Personalized variable dose of glucocorticoids arm

EXPERIMENTAL

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; 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

OTHER

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; 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)

Interventions

Glucocorticoids DRUG

Also known as: methylprednisolone

Fixed dose of glucocorticoids arm; Personalized variable dose of glucocorticoids arm

Antibiotics DRUG

Fixed dose of glucocorticoids arm; Personalized variable dose of glucocorticoids arm

Inhaled corticosteroid (ICS) DRUG

Fixed dose of glucocorticoids arm; Personalized variable dose of glucocorticoids arm

Long-Acting Muscarinic Antagonists(LAMA) DRUG

Fixed dose of glucocorticoids arm; Personalized variable dose of glucocorticoids arm

Short-acting beta2-agonist (SABA) DRUG

Fixed dose of glucocorticoids arm; Personalized variable dose of glucocorticoids arm

Physical treatments OTHER

Fixed dose of glucocorticoids arm; Personalized variable dose of glucocorticoids arm

long-acting beta2-agonist (LABA) DRUG

Fixed dose of glucocorticoids arm; Personalized variable dose of glucocorticoids arm

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Daping Hospital

Chongqing, Chongqing Municipality, 400042, China

Location

Related Publications (4)

• 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.

  PMID: 10465169 BACKGROUND

• 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.

  PMID: 20551406 BACKGROUND

• 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.

  PMID: 23695200 BACKGROUND

• 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.

  PMID: 34023318 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Glucocorticoids; Methylprednisolone; Anti-Bacterial Agents

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Anti-Infective Agents; Therapeutic Uses

Study Officials

• Guoqiang Cao, Medical Doctor

  Daping Hospital, Third Military Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice Chair of Department of Respiratory Medicine

Study Record Dates

• First Submitted: May 22, 2014
• First Posted: May 26, 2014
• Study Start: June 1, 2014
• Primary Completion: December 1, 2017
• Study Completion: April 1, 2018
• Last Updated: October 26, 2020

Record last verified: 2020-10

Locations

CN (1)