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Hospitalary Chronic Obstructive Pulmonary Disease Registry

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ClinicalTrials.gov Identifier: NCT02659189
Recruitment Status : Recruiting
First Posted : January 20, 2016
Last Update Posted : August 13, 2019
Sponsor:
Information provided by (Responsible Party):
Hospital Italiano de Buenos Aires

Study Description
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Brief 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.

Condition or disease
COPD Exacerbations Death

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
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: Hospitalary Chronic Obstructive Pulmonary Disease Registry
Study Start Date : July 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Death [ Time Frame: At 6 months after enrollment ]
    All cause of death


Secondary Outcome Measures :
  1. Morbidity [ Time Frame: At 6 months after enrollment ]
    Saint George respiratory questionnaire

  2. Functional decline (Forced expired volume at one second) [ Time Frame: At 12 months after enrollment ]
    Forced expired volume at one second

  3. Exacerbations (defined as an increase in symptoms that requires treatment) [ Time Frame: At 12 months after enrollment ]
    Number of exacerbations in the timeframe (defined as an increase in symptoms that requires treatment)


Eligibility Criteria
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Ages Eligible for Study:   40 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients older than 40 years with a chronic obstructive pulmonary disease diagnosis according to global initiative for chronic obstructive lung disease criteria.
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02659189


Contacts
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Contact: Diego H Giunta, MD 541149590200 ext 4806 diego.giunta@hospitalitaliano.org.ar

Locations
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Argentina
Hospital Italiano de Buenos Aires, Peron 4190 Recruiting
Ciudad Autonoma de Buenos Aires, Capital Federal, Argentina, C1199ABB
Contact: Diego H Giunta, MD    +54 9 11 5825-6489    diego.giunta@hospitalitaliano.org.ar   
Contact: Cristina M Elizondo, MD    +54 9 11 5745-8048    cristina.elizondo@hospitalitaliano.org.ar   
Sponsors and Collaborators
Hospital Italiano de Buenos Aires
Investigators
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Principal Investigator: Diego H Giunta, MD Hospital Italiano de Buenos Aires
More Information
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Additional Information:

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

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Responsible Party: Hospital Italiano de Buenos Aires
ClinicalTrials.gov Identifier: NCT02659189    
Other Study ID Numbers: 2677
First Posted: January 20, 2016    Key Record Dates
Last Update Posted: August 13, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Lung Diseases
Respiratory Tract Diseases