Pulmonary Disease, Chronic Obstructive Patients Admitted in Emergency Department for Acute ExacerbationUTAPE BPCONCT01857947
Prognosis Value of Pro-adrenomedullin in Acute Exacerbations of COPD in ER
A study testing AECOPD Mr proADM in people with Pulmonary Disease, Chronic Obstructive Patients Admitted in Emergency Department for Acute Exacerbation, run by ThermoFisher Scientific Brahms Biomarkers France at 2 sites in France.
Trial summary
The purpose of this study is to determine whether pro-adrenomedullin (Mr proADM)in addition to clinical evaluation is effective to predict outcome of acute exacerbations of COPD patients visiting the emergency room(ER). Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive Patients Admitted in Emergency Department for Acute Exacerbation
- What is being tested?
- AECOPD Mr proADM
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 370 participants
- Where
- 2 sitesFrance
- Study dates
- Mar 2013to Dec 2014
- 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
- patients > 40 years old
- Acute exacerbation of COPD
Who cannot join
- Medico social conditions not allowing home discharge
- Other causes of Dyspnea: Pneumothorax, pulmonary embolism, pulmonary oedema, lung cancer
- Pneumonia on chest ray
- acute respiratory distress requiring immediate ICU transfer
Trial locations and contacts
2 sites in 1 country.
France2 sites
Hôpital Lariboisière
Paris, Paris, 75010
Pitié Salpétrière Hospital
Paris, Paris, 75013
About this study
Official title: Usefulness of Pro-adrenomedullin (MR proADM)as a Predictor of Outcome in Acute Exacerbations of COPD Visiting the Emergency Room
The purpose of this study is to determine whether pro-adrenomedullin (Mr proADM)in addition to clinical evaluation is effective to predict outcome of acute exacerbations of COPD patients visiting the emergency room(ER).
Read the detailed description
Acute exacerbation of COPD (AECOPD)are usual and frequent cause of admission in emergency room (ER). No validated clinical or biological predictor of evolution are available.
The main objective is to determine the prognosis value of Mr proADM in addition to the clinical risk stratification for AE COPD patients in ER.
Patients presenting with a AECOPD diagnosis in ER will have a blood sample collected and freezed at their admission. Mr proADM will be assessed at the end of the study. Clinicians in charge of patients will not have the result during the management of their patients. This study implies no change in the patients' management.
Data related to the patients'demographic,current exacerbation and basic COPD characteristics will be collected.
- Being tested
- AECOPD Mr proADM
- Keywords
- AECOPD Mr ProADM Biomarkers ER Outcome
- Medical subject headings
- Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AECOPD Mr proADMOther
| Study group | Role | What they receive |
|---|---|---|
| AECOPD Mr proADM | No intervention | Patients involved in this study will have a simple blood sample collected for Mr proADM assessment at the end of study Receives: Other: AECOPD Mr proADM |
What is being measured
The primary outcome is the main question the study is designed to answer.
composite outcome measure
Death, subsequently transfer to ICU, relapse, need to be ventilated after 24 hours of their admission in ER
Measured: at Day 30
Secondary outcomes (2)
composite outcome
Death, subsequently transfer to ICU, relapse, need to be ventilated after 24 hours of their admission in ER
Measured: at Day 7 of ER admission
correlation between Mr proADM and patients Severity
Correlation between MR proADM and patient's severity
Measured: at Day 7 and Day 30 of ED admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2013 (estimated)
- Study startMar 2013
- Primary completionOct 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Disease, Chronic Obstructive Patients Admitted in Emergency Department for Acute ExacerbationStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 370 participants (actual)
Sponsor and investigators
- Lead sponsor
- ThermoFisher Scientific Brahms Biomarkers France
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Assistance Publique - Hôpitaux de Paris
- Responsible party
- Sponsor
- Investigators
- Nicolas Roche, MD PHD, Study chair, Hotel Dieu Hospital ParisMartin Dres, MD, Study director, Hopital Bicêtre Le Krémlin BicêtrePierre Hausfater, MD PHD, Principal investigator, Pitié Salpétrière Hospital Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01857947
- Sponsor's protocol ID
- UTAPE01
- Acronym
- UTAPE BPCO
- Status last verified
- Dec 2014
- First submitted
- 16 May 2013
- Last updated
- 3 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Usefulness of Pro-adrenomedullin (MR proADM)as a Predictor of Outcome in Acute Exacerbations of COPD Visiting the Emergency Room
- ClinicalTrials.gov ID
- NCT01857947
- Acronym / sponsor ID
- UTAPE BPCO / UTAPE01
- Keywords
- AECOPD Mr ProADM Biomarkers ER Outcome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 370 participants (actual)
- Lead sponsor
- ThermoFisher Scientific Brahms Biomarkers FranceIndustry (pharma, biotech, devices)
- Collaborators
- Assistance Publique - Hôpitaux de Paris
- Study start
- Mar 2013
- Primary completion
- Oct 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 20 May 2013 (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 purpose of this study is to determine whether pro-adrenomedullin (Mr proADM)in addition to clinical evaluation is effective to predict outcome of acute exacerbations of COPD patients visiting the emergency room(ER).
Detailed description
Acute exacerbation of COPD (AECOPD)are usual and frequent cause of admission in emergency room (ER). No validated clinical or biological predictor of evolution are available.
The main objective is to determine the prognosis value of Mr proADM in addition to the clinical risk stratification for AE COPD patients in ER.
Patients presenting with a AECOPD diagnosis in ER will have a blood sample collected and freezed at their admission. Mr proADM will be assessed at the end of the study. Clinicians in charge of patients will not have the result during the management of their patients. This study implies no change in the patients' management.
Data related to the patients'demographic,current exacerbation and basic COPD characteristics will be collected.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AECOPD Mr proADM | No intervention | Other: AECOPD Mr proADMPatients involved in this study will have a simple blood sample collected for Mr proADM assessment at the end of study |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients > 40 years old
- Acute exacerbation of COPD
Key exclusion criteria (4 listed)
- Medico social conditions not allowing home discharge
- Other causes of Dyspnea: Pneumothorax, pulmonary embolism, pulmonary oedema, lung cancer
- Pneumonia on chest ray
- acute respiratory distress requiring immediate ICU transfer
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 |
|---|---|---|
| AECOPD Mr proADM | Other | AECOPD Mr proADM |
Primary outcome
composite outcome measure
Time frame: at Day 30
Death, subsequently transfer to ICU, relapse, need to be ventilated after 24 hours of their admission in ER
2 secondary outcomes
composite outcome
Time frame: at Day 7 of ER admission
correlation between Mr proADM and patients Severity
Time frame: at Day 7 and Day 30 of ED admission
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 3 Dec 2014.
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Recruiting
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Acute Exacerbation of Chronic Obstructive Pulmonary Disease, Hypercapnic Acidosis
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.
Nicolas Roche, MD PHD study chair
Hotel Dieu Hospital Paris
Martin Dres, MD study director
Hopital Bicêtre Le Krémlin Bicêtre
Pierre Hausfater, MD PHD principal investigator
Pitié Salpétrière Hospital Paris
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AECOPD Mr proADM in people with Pulmonary Disease, Chronic Obstructive Patients Admitted in Emergency Department for Acute Exacerbation, run by ThermoFisher Scientific Brahms Biomarkers France at 2 sites in France.
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 4 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 3 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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?
composite outcome measure (time frame: at Day 30). 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 3 Dec 2014.