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Chronic Obstructive Pulmonary Disease Markers and Prognosis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by UPECLIN HC FM Botucatu Unesp.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
UPECLIN HC FM Botucatu Unesp
ClinicalTrials.gov Identifier:
NCT00605540
First received: January 18, 2008
Last updated: June 3, 2009
Last verified: June 2009
History of Changes
  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

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

Resource links provided by NLM:

U.S. FDA Resources

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 ]

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
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

No publications provided by UPECLIN HC FM Botucatu Unesp

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Irma de Godoy, Botucatu School of Medicine
ClinicalTrials.gov Identifier: NCT00605540     History of Changes
Other Study ID Numbers: upeclin/HC/FMB-Unesp-06
Study First Received: January 18, 2008
Last Updated: June 3, 2009
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by UPECLIN HC FM Botucatu Unesp:
COPD
Survival
Exacerbation
Disease markers

Additional relevant MeSH terms:
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 23, 2013