Hospitalary Chronic Obstructive Pulmonary Disease Registry

• Conditions: COPD Exacerbations; Death

• Registration Number: NCT02659189
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2016-01-05
• Study First Submitted QC: 2016-01-19
• Study First Posted: 2016-01-20
• Study Start: 2016-07
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-09
• Last Update Posted: 2019-08-13
• Primary Completion: 2019-12
• Study Completion: 2020-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Death	At 6 months after enrollment	All cause of death

Secondary Outcome Measures

Name	Time	Method
Exacerbations (defined as an increase in symptoms that requires treatment)	At 12 months after enrollment	Number of exacerbations in the timeframe (defined as an increase in symptoms that requires treatment)
Morbidity	At 6 months after enrollment	Saint George respiratory questionnaire
Functional decline (Forced expired volume at one second)	At 12 months after enrollment	Forced expired volume at one second

Trial Locations

Locations (1)

Hospital Italiano de Buenos Aires, Peron 4190; 🇦🇷 Ciudad Autonoma de Buenos Aires, Capital Federal, Argentina