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NCT02659189 Clinical Trial

Hospitalary Chronic Obstructive Pulmonary Disease Registry

Death Clinical Trial

Official title:
Hospitalary Chronic Obstructive Pulmonary Disease Registry

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02659189
Other study ID # 2677
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 2016
Est. completion date January 2020

Study information
Verified date August 2019
Source Hospital Italiano de Buenos Aires
Contact Diego H Giunta, MD
Phone 541149590200
Email diego.giunta@hospitalitaliano.org.ar
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 300
Est. completion date January 2020
Est. primary completion date December 2019
Accepts healthy volunteers No
Gender All
Age group 40 Years to 85 Years
Eligibility 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).

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Argentina Hospital Italiano de Buenos Aires, Peron 4190 Ciudad Autonoma de Buenos Aires Capital Federal

Sponsors (1)
Lead Sponsor Collaborator
Hospital Italiano de Buenos Aires

Country where clinical trial is conducted

Argentina, 

References & Publications (2)

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. — View Citation

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

Outcome
Type Measure Description Time frame Safety issue
Primary Death All cause of death At 6 months after enrollment
Secondary Morbidity Saint George respiratory questionnaire At 6 months after enrollment
Secondary Functional decline (Forced expired volume at one second) Forced expired volume at one second At 12 months after enrollment
Secondary 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) At 12 months after enrollment
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