Chronic Obstructive Pulmonary Disease Markers and Prognosis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Irma de Godoy, UPECLIN HC FM Botucatu Unesp
ClinicalTrials.gov Identifier:
NCT00605540
First received: January 18, 2008
Last updated: September 2, 2014
Last verified: May 2014
  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:


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

Primary Outcome Measures:
  • Forced Expiratory Volume in the First Second (FEV1) [ Time Frame: Baseline and after three years ] [ Designated as safety issue: Yes ]
    FEV1 values were measured by Spirometry using the KOKO Spirometer, before and 15 minutes after the inhalation of 400mcg of salbutamol.

  • Exercise Tolerance [ Time Frame: Baseline and after three years ] [ Designated as safety issue: Yes ]
    Tolerance exercise was evaluated by six-minute walking distance(6MWD)according to the American Thoracic Society guidelines.Patients were instructed to walk, attempting to cover as much ground as possible within 6 min. A research assistant timed the walk, and standardized verbal encouragement was given.

  • Body Composition [ Time Frame: Baseline and after three years ] [ Designated as safety issue: Yes ]
    Body composition was evaluated by Body Mass Index (BMI), which is dividing weight in kilograms by height in square meters.

  • Dyspnea [ Time Frame: Baseline and after three years ] [ Designated as safety issue: Yes ]
    Dyspnea was evaluated by Medical Research Council scale (MRC). MRC scale consists of only five items and it is based on activities that cause dyspnea. The patient reports the degree of dyspnea by choosing a value between 1 and 5. A higher number indicates greater sensation of dyspnea.

  • Health Status [ Time Frame: Baseline and after three years ] [ Designated as safety issue: Yes ]
    Saint George's Respiratory Questionnaire (SGRQ)was used to evaluate patient's health status. SGRQ includes three domains: symptoms, activities and impact of the disease. Each domain has a minimum score (zero) and maximum (662.5, 1209.1, and 2117.8, respectively). A total score is also calculated based on the results of three domains, with a score maximum of 3989.4. The total score is referred to as the percentage achieved by the patient related to this maximum score. Minimum score means there is no impairment in the health status and high score means maximum dysfunction.


Enrollment: 133
Study Start Date: January 2008
Study Completion Date: February 2012
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Study COPD population
Patients with diagnosis of mild to very severe chronic obstructive pulmonary disease

Detailed Description:

In a previous study, 133 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 be 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Brazil
Botucatu School of Medicine
Botucatu, SP, Brazil, 18618-000
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, PhD, UPECLIN HC FM Botucatu Unesp
ClinicalTrials.gov Identifier: NCT00605540     History of Changes
Other Study ID Numbers: upeclin/HC/FMB-Unesp-06
Study First Received: January 18, 2008
Results First Received: June 22, 2009
Last Updated: September 2, 2014
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
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 14, 2014