Chronic Obstructive Pulmonary Disease Markers and Prognosis - Full Text View

Sponsored by:	UPECLIN HC FM Botucatu Unesp
Information provided by:	UPECLIN HC FM Botucatu Unesp
ClinicalTrials.gov Identifier:	NCT00605540

Purpose

The study aim is to verify the association between the changes in markers of disease and patient´s prognosis in chronic obstructive pulmonary disease.

Condition
Chronic Obstructive Pulmonary Disease

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease)

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Three-Years Follow-up of Diagnostic and Prognostic Markers in Chronic Obstructive Pulmonary Disease

Further study details as provided by UPECLIN HC FM Botucatu Unesp:

Primary Outcome Measures:

Changes in COPD disease markers [ Time Frame: Three years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Exacerbation occurence [ Time Frame: Three years ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	120
Study Start Date:	January 2008
Estimated Study Completion Date:	December 2009

Groups/Cohorts
Observation COPD patients

Detailed Description:

In a previous study, 120 COPD patients were followed-up during the period of one-year. Analyses of the association between baseline characteristic and the occurence of disease exacerbation was performed. In this study, the patients included in the previous research will be contacted and invited to participate in a complete evaluation after a three-year period. The association of the changes in dyspnea perception, spirometry variables, body composition, quality of life and exercise tolerance measures with disease prognostic will studied.

Eligibility

Ages Eligible for Study:	40 Years to 95 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Pulmonary outpatient clinic

Criteria

Inclusion Criteria:

COPD diagnosis according to the GOLD criteria

Exclusion Criteria:

Asthma
Inability to perform pulmonary function and exercise tolerance tests
Recent myocardial infarction or unstable angina
Congestive heart failure: class III/IV

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00605540

Contacts

Contact: Irma de Godoy, PhD, MD	55-14-38822969	irma@fmb.unesp.br
Contact: Renata Ferrari, BS	55-14-38822969	renataferrarifisio@gmail.com

Locations

Brazil, SP
Botucatu School of Medicine	Recruiting
Botucatu, SP, Brazil, 18618-000
Principal Investigator: Irma de Godoy, PhD, MD

Sponsors and Collaborators

UPECLIN HC FM Botucatu Unesp

Investigators

Study Chair:

Irma de Godoy, PhD, MD

Botucatu School of Medicine

More Information

Responsible Party:	Botucatu School of Medicine ( Irma de Godoy )
Study ID Numbers:	upeclin/HC/FMB-Unesp-06
Study First Received:	January 18, 2008
Last Updated:	October 27, 2008
ClinicalTrials.gov Identifier:	NCT00605540
Health Authority:	Brazil: National Committee of Ethics in Research

Keywords provided by UPECLIN HC FM Botucatu Unesp:

COPD
Survival
Exacerbation
Disease markers

Study placed in the following topic categories:

Lung Diseases, Obstructive
Respiratory Tract Diseases
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive

ClinicalTrials.gov processed this record on January 14, 2009