Chronic Obstructive Pulmonary Disease Markers and Prognosis

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

Three-years Follow-up of Diagnostic and Prognostic Markers in Chronic Obstructive Pulmonary Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00605540
• Other study ID #: upeclin/HC/FMB-Unesp-06
• Status: Completed
• Phase: N/A
• First received: January 18, 2008
• Last updated: September 2, 2014
• Start date: January 2008
• Est. completion date: February 2012

Study information

• 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

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Locations

Country	Name	City	State
Brazil	Botucatu School of Medicine	Botucatu	SP

Sponsors (1)

Lead Sponsor	Collaborator
UPECLIN HC FM Botucatu Unesp

Country where clinical trial is conducted

Brazil, 

Outcome

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