Clinical trial NCT02659189: Hospitalary Chronic Obstructive Pulmonary Disease Registry
Official title: Hospitalary Chronic Obstructive Pulmonary Disease Registry
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COPD Exacerbations
Death
Lead sponsor: Hospital Italiano de Buenos Aires
Sponsor class: OTHER
First posted: 2016-01-20
Enrollment: 300
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility 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).

Primary outcomes:
measure: Death
timeFrame: At 6 months after enrollment
Secondary outcomes:
measure: Morbidity
timeFrame: At 6 months after enrollment
measure: Functional decline (Forced expired volume at one second)
timeFrame: At 12 months after enrollment
measure: Exacerbations (defined as an increase in symptoms that requires treatment)
timeFrame: At 12 months after enrollment
Other outcomes:
Locations:
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Hospital Italiano de Buenos Aires, Peron 4190
state: Capital Federal
Study officials:
affiliation: Hospital Italiano de Buenos Aires
name: Diego H Giunta, MD
role: PRINCIPAL_INVESTIGATOR
References:
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
citation: 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.