Chronic Obstructive Pulmonary DiseaseNCT02147015
Personalized Variable Versus Fixed Dose Glucocorticoid Therapy in AECOPD
A study testing Glucocorticoids, Antibiotics and Inhaled corticosteroid (ICS) in people with Chronic Obstructive Pulmonary Disease, run by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Glucocorticoids, Antibiotics and Inhaled corticosteroid (ICS)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 248 participants
- Where
- 1 siteChina
- Study dates
- Jun 2014to Apr 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Personalized Variable Versus Fixed Dose Corticosteroids Therapy in Hospitalized Patients With Acute Exacerbations of Chronic Obstructive Pulmonary Disease
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.
Read the 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.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Glucocorticoids, Antibiotics, Inhaled corticosteroid (ICS), Long-Acting Muscarinic Antagonists(LAMA), Short-acting beta2-agonist (SABA)
- Keywords
- Acute Exacerbations, Corticosteroids, Chronic Obstructive Pulmonary Disease, Doses
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlucocorticoidsDrug
Also called methylprednisolone
AntibioticsDrug
Inhaled corticosteroid (ICS)Drug
Long-Acting Muscarinic Antagonists(LAMA)Drug
Short-acting beta2-agonist (SABA)Drug
Physical treatmentsOther
long-acting beta2-agonist (LABA)Drug
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 6 months
Secondary outcomes (1)
length of hospital stay
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2014 (estimated)
- Study startJun 2014
- Primary completionDec 2017
- Study completionApr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 248 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guoqiang Cao,MD, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
- Investigators
- Guoqiang Cao, Medical Doctor, Principal investigator, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02147015
- Sponsor's protocol ID
- VIP
- Status last verified
- Oct 2020
- First submitted
- 22 May 2014
- Last updated
- 26 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
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. doi: 10.1016/s0140-6736(98)11326-0.
PubMed 10465169Lindenauer 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.
PubMed 20551406Leuppi 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.
PubMed 23695200Li 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.
PubMed 34023318
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Variable Versus Fixed Dose Corticosteroids Therapy in Hospitalized Patients With Acute Exacerbations of Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT02147015
- Acronym / sponsor ID
- VIP
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Acute Exacerbations, Corticosteroids, Chronic Obstructive Pulmonary Disease, Doses
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 248 participants (actual)
- Lead sponsor
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical UniversityUniversity, hospital or other
- Study start
- Jun 2014 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 26 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Personalized variable dose of glucocorticoids arm | Experimental | 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)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. |
| Fixed dose of glucocorticoids arm | Other | 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)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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GlucocorticoidsAlso: methylprednisolone | Drug | 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 |
Primary outcome
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)
1 secondary outcome
length of hospital stay
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2020.
- Background: PubMed 10465169Davies 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.
- Background: PubMed 20551406Lindenauer 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.
- Background: PubMed 23695200Leuppi 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.
- Derived from this study: PubMed 34023318Li 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guoqiang Cao, Medical Doctor principal investigator
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Glucocorticoids, Antibiotics and Inhaled corticosteroid (ICS) in people with Chronic Obstructive Pulmonary Disease, run by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment failure (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02147015, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2020.