Chronic Obstructive Pulmonary Disease Markers and Prognosis

September 2, 2014 updated by: Irma de Godoy, UPECLIN HC FM Botucatu Unesp

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

The study aim is to verify the association between the changes in markers of disease and patient´s prognosis in chronic obstructive pulmonary disease.

Study Overview

Status

Completed

Conditions

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

Enrollment (Actual)

133

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • SP
      • Botucatu, SP, Brazil, 18618-000
        • Botucatu School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 95 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Pulmonary outpatient clinic

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and after three years
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.
Baseline and after three years
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.
Baseline and after three years
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.
Baseline and after three years
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.
Baseline and after three years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UPECLIN HC FM Botucatu Unesp

Investigators

  • Study Chair: Irma de Godoy, PhD, MD, Botucatu School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

March 1, 2010

Study Completion (Actual)

February 1, 2012

Study Registration Dates

First Submitted

January 18, 2008

First Submitted That Met QC Criteria

January 18, 2008

First Posted (Estimate)

January 31, 2008

Study Record Updates

Last Update Posted (Estimate)

September 3, 2014

Last Update Submitted That Met QC Criteria

September 2, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • upeclin/HC/FMB-Unesp-06

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Chronic Obstructive Pulmonary Disease

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kuwait

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe