COPD ExacerbationsNCT02659189
Hospitalary Chronic Obstructive Pulmonary Disease Registry
An observational study of COPD Exacerbations and Death, run by Hospital Italiano de Buenos Aires at 1 site in Argentina.
Trial summary
The purpose of this study is to create an institutional registry of Chronic Obstructive Pulmonary disease through a prospective survey based on epidemiological data, risk factors, diagnosis, prognosis, treatment, monitoring and survival. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- COPD Exacerbations, Death
- How many people
- 300 participants
- Where
- 1 siteArgentina
- Study dates
- Jul 2016to Jan 2020
- How long will I take part?
- 3 Years
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients older than 40 years with a chronic obstructive pulmonary disease diagnosis according to global initiative for chronic obstructive lung disease criteria.
Who may be able to join
- Patients older than 40 years with a chronic obstructive pulmonary disease diagnosis according to global obstructive lung Global initiative for chronic Obstructive Lung Disease criteria.
- Follow up at the Hospital Italiano de Buenos Aires.
Who cannot join
- Refusal to participate or to agree to the informed consent.
- Known non chronic obstructive pulmonary disease respiratory disease (ej: Lung Cancer, Tuberculosis, Pulmonary Fibrosis, Neumoconiosis, Cystic Fibrosis, Sarcoidosis, etc)
- Severe alpha-1 antitripsin deficit (typr SZ or ZZ)
- Previously thoracic surgery (ej: lung volume reduction, lung transplantation).
Trial locations and contacts
1 site in 1 country.
Argentina1 site, 1 recruiting
- Recruiting
Hospital Italiano de Buenos Aires, Peron 4190
Buenos Aires, Buenos Aires F.D., C1199ABB
Diego H Giunta, MD, +54 9 11 5825-6489, diego.giunta@hospitalitaliano.org.ar
Cristina M Elizondo, MD, +54 9 11 5745-8048, cristina.elizondo@hospitalitaliano.org.ar
About this study
The purpose of this study is to create an institutional registry of Chronic Obstructive Pulmonary disease through a prospective survey based on epidemiological data, risk factors, diagnosis, prognosis, treatment, monitoring and survival.
Read the detailed description
The main goal is to describe the characteristics of chronic obstructive pulmonary disease patients, including their clinical, spirometric, exacerbation and mortality characteristics within the population of the Hospital Italiano de Buenos Aires.
- Conditions
- COPD Exacerbations, Death
- Medical subject headings
- Death
What is being measured
The primary outcome is the main question the study is designed to answer.
Death
All cause of death
Measured: At 6 months after enrollment
Secondary outcomes (3)
Morbidity
Saint George respiratory questionnaire
Measured: At 6 months after enrollment
Functional decline (Forced expired volume at one second)
Forced expired volume at one second
Measured: At 12 months after enrollment
Exacerbations (defined as an increase in symptoms that requires treatment)
Number of exacerbations in the timeframe (defined as an increase in symptoms that requires treatment)
Measured: At 12 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2016 (estimated)
- Study startJul 2016
- Primary completionDec 2019 (estimated)
- Study completionJan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for COPD ExacerbationsStudies 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
- 300 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Hospital Italiano de Buenos Aires
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Diego H Giunta, MD, Principal investigator, Hospital Italiano de Buenos Aires
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02659189
- Sponsor's protocol ID
- 2677
- Status last verified
- Aug 2019
- First submitted
- 5 Jan 2016
- Last updated
- 13 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Muiño Adriana, María Victoria López Varela, and Ana María Menezes. Prevalencia de la enfermedad pulmonar obstructiva crónica y sus principales factores de riesgo: proyecto platino en Montevideo. Revista Médica del Uruguay. 2005;21: 37-48
Moreira GL, Gazzotti MR, Manzano BM, Nascimento O, Perez-Padilla R, Menezes AM, Jardim JR. Incidence of chronic obstructive pulmonary disease based on three spirometric diagnostic criteria in Sao Paulo, Brazil: a nine-year follow-up since the PLATINO prevalence study. Sao Paulo Med J. 2015 May-Jun;133(3):245-51. doi: 10.1590/1516-3180.2015.9620902. Epub 2015 Jun 1.
PubMed 26176929
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hospitalary Chronic Obstructive Pulmonary Disease Registry
- ClinicalTrials.gov ID
- NCT02659189
- Acronym / sponsor ID
- 2677
- Conditions
- COPD Exacerbations, Death
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Hospital Italiano de Buenos AiresUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Jan 2020 (estimated)
- First posted
- 20 Jan 2016 (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 create an institutional registry of Chronic Obstructive Pulmonary disease through a prospective survey based on epidemiological data, risk factors, diagnosis, prognosis, treatment, monitoring and survival.
Detailed description
The main goal is to describe the characteristics of chronic obstructive pulmonary disease patients, including their clinical, spirometric, exacerbation and mortality characteristics within the population of the Hospital Italiano de Buenos Aires.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients older than 40 years with a chronic obstructive pulmonary disease diagnosis according to global initiative for chronic obstructive lung disease criteria.
Key inclusion criteria (2 listed)
- Patients older than 40 years with a chronic obstructive pulmonary disease diagnosis according to global obstructive lung Global initiative for chronic Obstructive Lung Disease criteria.
- Follow up at the Hospital Italiano de Buenos Aires.
Key exclusion criteria (4 listed)
- Refusal to participate or to agree to the informed consent.
- Known non chronic obstructive pulmonary disease respiratory disease (ej: Lung Cancer, Tuberculosis, Pulmonary Fibrosis, Neumoconiosis, Cystic Fibrosis, Sarcoidosis, etc)
- Severe alpha-1 antitripsin deficit (typr SZ or ZZ)
- Previously thoracic surgery (ej: lung volume reduction, lung transplantation).
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
Death
Time frame: At 6 months after enrollment
All cause of death
3 secondary outcomes
Morbidity
Time frame: At 6 months after enrollment
Functional decline (Forced expired volume at one second)
Time frame: At 12 months after enrollment
Exacerbations (defined as an increase in symptoms that requires treatment)
Time frame: At 12 months after enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2019.
- BackgroundMuiño Adriana, María Victoria López Varela, and Ana María Menezes. Prevalencia de la enfermedad pulmonar obstructiva crónica y sus principales factores de riesgo: proyecto platino en Montevideo. Revista Médica del Uruguay. 2005;21: 37-48
- Background: PubMed 26176929Moreira GL, Gazzotti MR, Manzano BM, Nascimento O, Perez-Padilla R, Menezes AM, Jardim JR. Incidence of chronic obstructive pulmonary disease based on three spirometric diagnostic criteria in Sao Paulo, Brazil: a nine-year follow-up since the PLATINO prevalence study. Sao Paulo Med J. 2015 May-Jun;133(3):245-51. doi: 10.1590/1516-3180.2015.9620902. Epub 2015 Jun 1.
- Individual participant dataSharing planned: No
Related trials for COPD Exacerbations
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Ensifentrine (MK-5884) Study for the Prevention of Chronic Obstructive Pulmonary Disease (COPD) Exacerbations in Adults With a History of Moderate or Severe Exacerbations While Receiving Standard of Care (SOC) (MK-5884-031/RPL554/ENHANCE-3)
Pulmonary Disease, Chronic Obstructive
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FreeDom: Innovative Strategy for the Management of COPD Exacerbations
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Investigating Senolytic Properties in Pulmonary Rehabilitation and Metformin in COPD Exacerbations
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The AIRWARD Study: A Study to Test Whether Verducatib Helps People With Chronic Obstructive Pulmonary Disease
Chronic Obstructive Pulmonary Disease
RecruitingPhase 4
Genetic Variation in IgG in Alpha 1 Antitrypsin Deficiency
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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.
Diego H Giunta, MD principal investigator
Hospital Italiano de Buenos Aires
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 COPD Exacerbations and Death, run by Hospital Italiano de Buenos Aires at 1 site in Argentina.
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: status not confirmed, as of the sponsor's last update on 13 Aug 2019. 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 Argentina. 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 Diego H Giunta, MD (541149590200 ext. 4806, diego.giunta@hospitalitaliano.org.ar), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Death (time frame: At 6 months after enrollment). 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 NCT02659189, which also lists 2 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 13 Aug 2019.