Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Hospitalary Chronic Obstructive Pulmonary Disease Registry

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

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.

Layout table for study information
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




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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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).

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
Layout table for location contacts
Contact: Diego H Giunta, MD 541149590200 ext 4806 diego.giunta@hospitalitaliano.org.ar

Locations
Layout table for location information
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
Layout table for investigator information
Principal Investigator: Diego H Giunta, MD Hospital Italiano de Buenos Aires
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

Layout table for additonal information
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:
Layout table for MeSH terms
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Lung Diseases
Respiratory Tract Diseases