Chronic Obstructive Pulmonary Disease Markers and Prognosis


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

Full Title of Study: “Three-years Follow-up of Diagnostic and Prognostic Markers in Chronic Obstructive Pulmonary Disease”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: March 2010

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.

Arms, Groups and Cohorts

  • Study COPD population
    • Patients with diagnosis of mild to very severe chronic obstructive pulmonary disease

Clinical Trial Outcome Measures

Primary Measures

  • Forced Expiratory Volume in the First Second (FEV1)
    • Time Frame: Baseline and after three years
    • 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
    • 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
    • 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
    • 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
    • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 40 Years

Maximum Age: 95 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • UPECLIN HC FM Botucatu Unesp
  • Provider of Information About this Clinical Study
    • Principal Investigator: Irma de Godoy, PhD – UPECLIN HC FM Botucatu Unesp
  • Overall Official(s)
    • Irma de Godoy, PhD, MD, Study Chair, Botucatu School of Medicine

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