Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Chronic Obstructive Pulmonary Disease Markers and Prognosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Chronic Obstructive Pulmonary Disease
Enrollment 133
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Chronic Obstructive Pulmonary Disease Markers Over Three Years
Hide Arm/Group Description All patients were evaluated at baseline and attended at the clinics every six months for three years or until death.
Period Title: Overall Study
Started 133
Completed 95
Not Completed 38
Reason Not Completed
Death             15
Lost to Follow-up             23
Arm/Group Title Chronic Obstructive Pulmonary Disease Markers Over Three Years
Hide Arm/Group Description All patients were evaluated at baseline and attended at the clinics every six months for three years or until death.
Overall Number of Baseline Participants 133
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 133 participants
<=18 years
0
   0.0%
Between 18 and 65 years
66
  49.6%
>=65 years
67
  50.4%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 133 participants
64.8  (9.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 133 participants
Female
41
  30.8%
Male
92
  69.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Brazil Number Analyzed 133 participants
133
1.Primary Outcome
Title Forced Expiratory Volume in the First Second (FEV1)
Hide Description FEV1 values were measured by Spirometry using the KOKO Spirometer, before and 15 minutes after the inhalation of 400mcg of salbutamol.
Time Frame Baseline and after three years
Hide Outcome Measure Data
Hide Analysis Population Description
The sampling frame for this study was consecutive COPD patients recruited from the outpatient clinic of Botucatu Medical School.
Arm/Group Title Chronic Obstructive Pulmonary Disease Markers Over Three Years
Hide Arm/Group Description:
All patients were evaluated at baseline and attended at the clinics every six months for three years or until death.
Overall Number of Participants Analyzed 95
Median (Inter-Quartile Range)
Unit of Measure: Percentage predicted
Baseline assessment
54
(41 to 73)
After three-year assessment
54
(40 to 70)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Chronic Obstructive Pulmonary Disease Markers Over Three Years
Comments All data were analyzed using SigmaStat 3.2 (Inc., USA) software. Mean ± SD or median interquartile range (25-75%) was used depending on the data distribution. Wilcoxon test was applied to compare the characteristics at baseline to those observed after 3 years.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.09
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
2.Primary Outcome
Title Exercise Tolerance
Hide Description 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.
Time Frame Baseline and after three years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Chronic Obstructive Pulmonary Disease Markers Over Three Years
Hide Arm/Group Description:
All patients were evaluated at baseline and attended at the clinics every six months for three years or until death.
Overall Number of Participants Analyzed 95
Mean (Standard Deviation)
Unit of Measure: meters
Baseline assessment 438  (86)
After three-year assessment 412  (100)
3.Primary Outcome
Title Body Composition
Hide Description Body composition was evaluated by Body Mass Index (BMI), which is dividing weight in kilograms by height in square meters.
Time Frame Baseline and after three years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Chronic Obstructive Pulmonary Disease Markers Over Three Years
Hide Arm/Group Description:
All patients were evaluated at baseline and attended at the clinics every six months for three years or until death.
Overall Number of Participants Analyzed 95
Median (Inter-Quartile Range)
Unit of Measure: Kg/m^2
Baseline assessment
25
(22 to 29)
After three-year assessment
25
(22 to 29)
4.Primary Outcome
Title Dyspnea
Hide Description 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.
Time Frame Baseline and after three years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Chronic Obstructive Pulmonary Disease Markers Over Three Years
Hide Arm/Group Description:
All patients were evaluated at baseline and attended at the clinics every six months for three years or until death.
Overall Number of Participants Analyzed 95
Median (Inter-Quartile Range)
Unit of Measure: Scores on a scale
Baseline assessment
1
(1 to 2)
After three-year assessment
2
(1 to 3)
5.Primary Outcome
Title Health Status
Hide Description 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.
Time Frame Baseline and after three years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Chronic Obstructive Pulmonary Disease Markers Over Three Years
Hide Arm/Group Description:
All patients were evaluated at baseline and attended at the clinics every six months for three years or until death.
Overall Number of Participants Analyzed 95
Mean (Standard Deviation)
Unit of Measure: Percentage of total score
Baseline assessment 42  (19)
After three-year assessment 44  (19)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Chronic Obstructive Pulmonary Disease
Hide Arm/Group Description [Not Specified]
All-Cause Mortality
Chronic Obstructive Pulmonary Disease
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Chronic Obstructive Pulmonary Disease
Affected / at Risk (%)
Total   0/133 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Chronic Obstructive Pulmonary Disease
Affected / at Risk (%)
Total   0/133 (0.00%) 
We excluded patients with comorbidities; therefore, many patients seen in clinical practice may not have been well represented in our study.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Renata Ferrari
Organization: HC/FMB-Unesp
Phone: 55 14 38116213
EMail: renataferrarifisio@gmail.com
Layout table for additonal information
Responsible Party: Irma de Godoy, UPECLIN HC FM Botucatu Unesp
ClinicalTrials.gov Identifier: NCT00605540    
Other Study ID Numbers: upeclin/HC/FMB-Unesp-06
First Submitted: January 18, 2008
First Posted: January 31, 2008
Results First Submitted: June 22, 2009
Results First Posted: September 3, 2014
Last Update Posted: September 3, 2014