Pulmonary Disease, Chronic ObstructiveADEG-EPOCNCT04237896
Compliance With Clinical Guidelines and Effect on Patient Outcome of Treatment of Hospitalised Exacerbations of COPD
An observational study of Pulmonary Disease, Chronic Obstructive, run by Sociedad Española De Medicina Interna at 1 site in Spain.
Trial summary
Rationale. Currently there are well-established guidelines for the management of stable COPD. However, recommendations on the treatment of COPD exacerbations (E-COPD) are based on observational studies and low-quality clinical trials. Read more about this study
- Who is it for?
- Ages 40 to 100 years
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- How many people
- 400 participants
- Where
- 1 siteSpain
- Study dates
- 27 Jan 2020to 30 Aug 2020
- How long will I take part?
- 3 Months
- Phase
- Observational
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients older than 40 years who have required a hospital stay for an exacerbation of COPD prospectively followed 90 days after discharge.
Who may be able to join
- Age over 40 years.
- COPD patient hospitalized with the main diagnosis of exacerbation of COPD and whose main diagnosis is confirmed by the discharge report and the local investigator.
Who cannot join
- Terminal disease
- Absence of spirometry confirmation of the COPD diagnosis.
- Presence of other diseases that can cause symptoms like those of a COPD exacerbation (e.g. heart failure, pneumonia, etc.), where exacerbation of COPD is not the main cause of admission.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Compliance With Clinical Guidelines and Effect on Patient Outcome of Real-life Treatment of Hospitalised Exacerbations of COPD: a Nationwide Study in Spain
Rationale. Currently there are well-established guidelines for the management of stable COPD. However, recommendations on the treatment of COPD exacerbations (E-COPD) are based on observational studies and low-quality clinical trials. In addition, there are some controversial aspects, such as treatment with systemic steroids. On the other hand, the available information on the adherence to the recommendations of the clinical practice guidelines (CPG) and its impact on the outcome of patients is scarce.
Main objectives. (1) To examine the appropriateness of two clinical guidelines (GOLD and GesEPOC) of the current management of hospitalized exacerbations of COPD; (2) To determine in real-life clinical practice the impact of adherence to CPG recommendations for management of COPD exacerbations as an outcome of the disease (stay, in-hospital mortality, and 90-days post-discharge readmissions and mortality); (3) To examine the appropriateness of two clinical guidelines (GOLD and GesEPOC) of the treatment of stable COPD at admission and after discharge in patients hospitalized with exacerbated COPD; (4) To determinate in real-life clinical practice the impact of the suitability to CPG recommendations for treatment of stable COPD on 90-day post-discharge mortality and readmission of COPD.
Method. National, multicenter, observational and longitudinal study of the first consecutive 20 patients hospitalized for exacerbations of COPD between December 10 and 23, 2019 in the Internal Medicine Services of the participating Centers. Patients will be followed 90 days after discharge. A total of 400 patients will be recruited in 20 Spanish hospitals (20 per center). Independent variables: age, sex, admission service, body mass index, dyspnea (mMRC), obstruction (FEV¬₁), exacerbations in the previous year, comorbidities, bronchodilator treatment prior to admission, criteria of adequacy to the CPG in the clinical evaluation and treatment, hyperglycemia during the first 24 hours of admission, treatment of hyperglycemia and bronchodilator treatment at discharge. Outcomes: in-hospital mortality, mortality at 90 days, re-admission at 90 days. Statistical analysis: Parametric and non-parametric tests, Kaplan-Meier and ROC curves and multiple logistic regression.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- Chronic obstructive pulmonary disease, Acute exacerbation, Inpatients, Clinical practice guidelines, Bronchodilators, Compliance
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Patient Compliance
What is being measured
The primary outcome is the main question the study is designed to answer.
IN-HOSPITAL MORTALITY
death from any cause
Measured: during the admission of the index episode
30-day MORTALITY
death from any cause
Measured: <30 days
90-day MORTALITY
death from any cause
Measured: 31-90 days
30-day READMISSIONS
Readmission for an exacerbation of COPD
Measured: < 30 days
30-day READMISSIONS
Readmission for an exacerbation of COPD
Measured: 31-90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2020
- Study start27 Jan 2020 (estimated)
- Primary completion30 Jul 2020 (estimated)
- Study completion30 Aug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Sociedad Española De Medicina Interna
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Responsible party
- Sponsor
- Investigators
- Francisco J Medrano, Principal investigator, Sociedad Española De Medicina Interna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04237896
- Sponsor's protocol ID
- SEMI-2019-1-COPD
- Acronym
- ADEG-EPOC
- Status last verified
- Jan 2020
- First submitted
- 19 Jan 2020
- Last updated
- 27 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compliance With Clinical Guidelines and Effect on Patient Outcome of Real-life Treatment of Hospitalised Exacerbations of COPD: a Nationwide Study in Spain
- ClinicalTrials.gov ID
- NCT04237896
- Acronym / sponsor ID
- ADEG-EPOC / SEMI-2019-1-COPD
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- Chronic obstructive pulmonary disease, Acute exacerbation, Inpatients, Clinical practice guidelines, Bronchodilators, Compliance
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Sociedad Española De Medicina InternaUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- 27 Jan 2020 (estimated)
- Primary completion
- 30 Jul 2020 (estimated)
- Study completion
- 30 Aug 2020 (estimated)
- First posted
- 23 Jan 2020 (actual)
- 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.
Rationale. Currently there are well-established guidelines for the management of stable COPD. However, recommendations on the treatment of COPD exacerbations (E-COPD) are based on observational studies and low-quality clinical trials. In addition, there are some controversial aspects, such as treatment with systemic steroids. On the other hand, the available information on the adherence to the recommendations of the clinical practice guidelines (CPG) and its impact on the outcome of patients is scarce.
Main objectives. (1) To examine the appropriateness of two clinical guidelines (GOLD and GesEPOC) of the current management of hospitalized exacerbations of COPD; (2) To determine in real-life clinical practice the impact of adherence to CPG recommendations for management of COPD exacerbations as an outcome of the disease (stay, in-hospital mortality, and 90-days post-discharge readmissions and mortality); (3) To examine the appropriateness of two clinical guidelines (GOLD and GesEPOC) of the treatment of stable COPD at admission and after discharge in patients hospitalized with exacerbated COPD; (4) To determinate in real-life clinical practice the impact of the suitability to CPG recommendations for treatment of stable COPD on 90-day post-discharge mortality and readmission of COPD.
Method. National, multicenter, observational and longitudinal study of the first consecutive 20 patients hospitalized for exacerbations of COPD between December 10 and 23, 2019 in the Internal Medicine Services of the participating Centers. Patients will be followed 90 days after discharge. A total of 400 patients will be recruited in 20 Spanish hospitals (20 per center). Independent variables: age, sex, admission service, body mass index, dyspnea (mMRC), obstruction (FEV¬₁), exacerbations in the previous year, comorbidities, bronchodilator treatment prior to admission, criteria of adequacy to the CPG in the clinical evaluation and treatment, hyperglycemia during the first 24 hours of admission, treatment of hyperglycemia and bronchodilator treatment at discharge. Outcomes: in-hospital mortality, mortality at 90 days, re-admission at 90 days. Statistical analysis: Parametric and non-parametric tests, Kaplan-Meier and ROC curves and multiple logistic regression.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
Who may qualify
- Ages
- 40 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients older than 40 years who have required a hospital stay for an exacerbation of COPD prospectively followed 90 days after discharge.
Key inclusion criteria (2 listed)
- Age over 40 years.
- COPD patient hospitalized with the main diagnosis of exacerbation of COPD and whose main diagnosis is confirmed by the discharge report and the local investigator.
Key exclusion criteria (3 listed)
- Terminal disease
- Absence of spirometry confirmation of the COPD diagnosis.
- Presence of other diseases that can cause symptoms like those of a COPD exacerbation (e.g. heart failure, pneumonia, etc.), where exacerbation of COPD is not the main cause of admission.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
IN-HOSPITAL MORTALITY
Time frame: during the admission of the index episode
death from any cause
30-day MORTALITY
Time frame: <30 days
death from any cause
90-day MORTALITY
Time frame: 31-90 days
death from any cause
30-day READMISSIONS
Time frame: < 30 days
Readmission for an exacerbation of COPD
30-day READMISSIONS
Time frame: 31-90 days
Readmission for an exacerbation of COPD
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2020.
- Individual participant dataSharing planned: No
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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.
Francisco J Medrano principal investigator
Sociedad Española De Medicina Interna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Disease, Chronic Obstructive, run by Sociedad Española De Medicina Interna at 1 site in Spain.
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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 27 Jan 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 Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Francisco J Medrano, MD (+34 654824512, medrano@cica.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IN-HOSPITAL MORTALITY (time frame: during the admission of the index episode). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Jan 2020.