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Chronic Obstructive Pulmonary Disease Markers and Prognosis

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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

Tracking Information
First Submitted Date January 18, 2008
First Posted Date January 31, 2008
Results First Submitted Date June 22, 2009
Results First Posted Date September 3, 2014
Last Update Posted Date September 3, 2014
Study Start Date January 2008
Actual Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 2, 2014)
  • 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.
Original Primary Outcome Measures
 (submitted: January 18, 2008)
Changes in COPD disease markers [ Time Frame: Three years ]
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures
 (submitted: January 18, 2008)
Exacerbation occurence [ Time Frame: Three years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Chronic Obstructive Pulmonary Disease Markers and Prognosis
Official Title Three-years Follow-up of Diagnostic and Prognostic Markers in Chronic Obstructive Pulmonary Disease
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.
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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Pulmonary outpatient clinic
Condition Chronic Obstructive Pulmonary Disease
Intervention Not Provided
Study Groups/Cohorts Study COPD population
Patients with diagnosis of mild to very severe chronic obstructive pulmonary disease
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: September 2, 2014)
133
Original Estimated Enrollment
 (submitted: January 18, 2008)
120
Actual Study Completion Date February 2012
Actual Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 40 Years to 95 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Brazil
Removed Location Countries  
 
Administrative Information
NCT Number NCT00605540
Other Study ID Numbers upeclin/HC/FMB-Unesp-06
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Irma de Godoy, UPECLIN HC FM Botucatu Unesp
Study Sponsor UPECLIN HC FM Botucatu Unesp
Collaborators Not Provided
Investigators
Study Chair: Irma de Godoy, PhD, MD Botucatu School of Medicine
PRS Account UPECLIN HC FM Botucatu Unesp
Verification Date May 2014