ClinicalTrials.gov
ClinicalTrials.gov Menu

Chronic Obstructive Pulmonary Disease Markers and Prognosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00605540
Recruitment Status : Completed
First Posted : January 31, 2008
Results First Posted : September 3, 2014
Last Update Posted : September 3, 2014
Sponsor:
Information provided by (Responsible Party):
Irma de Godoy, UPECLIN HC FM Botucatu Unesp

Brief Summary:
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 or disease
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.

Study Type : Observational
Actual Enrollment : 133 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Three-years Follow-up of Diagnostic and Prognostic Markers in Chronic Obstructive Pulmonary Disease
Study Start Date : January 2008
Actual Primary Completion Date : March 2010
Actual Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases
U.S. FDA Resources

Group/Cohort
Study COPD population
Patients with diagnosis of mild to very severe chronic obstructive pulmonary disease



Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   40 Years to 95 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: January 31, 2008    Key Record Dates
Results First Posted: September 3, 2014
Last Update Posted: September 3, 2014
Last Verified: May 2014

Keywords provided by Irma de Godoy, UPECLIN HC FM Botucatu Unesp:
COPD
Survival
Exacerbation
Disease markers

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