Chronic Obstructive Pulmonary Disease Markers and Prognosis

Completed

• Conditions: Chronic Obstructive Pulmonary Disease

• Registration Number: NCT00605540
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-01-18
• Study First Submitted QC: 2008-01-18
• Study First Posted: 2008-01-31
• Results First Submitted: 2009-06-22
• Primary Completion: 2010-03
• Study Completion: 2012-02
• Status Verified: 2014-05
• Results First Submitted QC: 2014-09-02
• Last Update Submitted: 2014-09-02
• Results First Posted: 2014-09-03
• Last Update Posted: 2014-09-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 133

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Body Composition	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	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	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.
Exercise Tolerance	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.
Forced Expiratory Volume in the First Second (FEV1)	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.

Trial Locations

Locations (1)

Botucatu School of Medicine; 🇧🇷 Botucatu, SP, Brazil