Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
Three-years Follow-up of Diagnostic and Prognostic Markers in Chronic Obstructive Pulmonary Disease
Verified date | May 2014 |
Source | UPECLIN HC FM Botucatu Unesp |
Contact | n/a |
Is FDA regulated | No |
Health authority | Brazil: National Committee of Ethics in Research |
Study type | Observational |
The study aim is to verify the association between the changes in markers of disease and patient´s prognosis in chronic obstructive pulmonary disease.
Status | Completed |
Enrollment | 133 |
Est. completion date | February 2012 |
Est. primary completion date | March 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 40 Years to 95 Years |
Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Brazil | Botucatu School of Medicine | Botucatu | SP |
Lead Sponsor | Collaborator |
---|---|
UPECLIN HC FM Botucatu Unesp |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Forced Expiratory Volume in the First Second (FEV1) | FEV1 values were measured by Spirometry using the KOKO Spirometer, before and 15 minutes after the inhalation of 400mcg of salbutamol. | Baseline and after three years | Yes |
Primary | Exercise Tolerance | 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. | Baseline and after three years | Yes |
Primary | Body Composition | Body composition was evaluated by Body Mass Index (BMI), which is dividing weight in kilograms by height in square meters. | Baseline and after three years | Yes |
Primary | Dyspnea | 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. | Baseline and after three years | Yes |
Primary | Health Status | 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. | Baseline and after three years | Yes |
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