NCT02659189

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 5, 2016

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 20, 2016

Completed
5 months until next milestone

Study Start

First participant enrolled

July 1, 2016

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

August 13, 2019

Status Verified

August 1, 2019

Enrollment Period

3.4 years

First QC Date

January 5, 2016

Last Update Submit

August 9, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Death

    All cause of death

    At 6 months after enrollment

Secondary Outcomes (3)

  • Morbidity

    At 6 months after enrollment

  • Functional decline (Forced expired volume at one second)

    At 12 months after enrollment

  • Exacerbations (defined as an increase in symptoms that requires treatment)

    At 12 months after enrollment

Eligibility Criteria

Age40 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Italiano de Buenos Aires, Peron 4190

Buenos Aires, Buenos Aires F.D., C1199ABB, Argentina

RECRUITING

Related Publications (2)

  • 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

    BACKGROUND
  • 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.

    PMID: 26176929BACKGROUND

MeSH Terms

Conditions

Death

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Diego H Giunta, MD

    Hospital Italiano de Buenos Aires

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 5, 2016

First Posted

January 20, 2016

Study Start

July 1, 2016

Primary Completion

December 1, 2019

Study Completion

January 1, 2020

Last Updated

August 13, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations