Trial Outcomes & Findings for Chronic Obstructive Pulmonary Disease Markers and Prognosis (NCT NCT00605540)

NCT ID: NCT00605540

Last Updated: 2014-09-03

Results Overview

FEV1 values were measured by Spirometry using the KOKO Spirometer, before and 15 minutes after the inhalation of 400mcg of salbutamol.

• Recruitment status: COMPLETED
• Target enrollment: 133 participants
• Primary outcome timeframe: Baseline and after three years
• Results posted on: 2014-09-03

Participant Flow

Participant milestones

Measure	Chronic Obstructive Pulmonary Disease Markers Over Three Years All patients were evaluated at baseline and attended at the clinics every six months for three years or until death.
Overall Study STARTED	133
Overall Study COMPLETED	95
Overall Study NOT COMPLETED	38

Reasons for withdrawal

Measure	Chronic Obstructive Pulmonary Disease Markers Over Three Years All patients were evaluated at baseline and attended at the clinics every six months for three years or until death.
Overall Study Death	15
Overall Study Lost to Follow-up	23

Baseline Characteristics

Chronic Obstructive Pulmonary Disease Markers and Prognosis

Baseline characteristics by cohort

Measure	Chronic Obstructive Pulmonary Disease Markers Over Three Years n=133 Participants All patients were evaluated at baseline and attended at the clinics every six months for three years or until death.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	66 Participants n=5 Participants
Age, Categorical >=65 years	67 Participants n=5 Participants
Age, Continuous	64.8 years STANDARD_DEVIATION 9.5 • n=5 Participants
Sex: Female, Male Female	41 Participants n=5 Participants
Sex: Female, Male Male	92 Participants n=5 Participants
Region of Enrollment Brazil	133 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and after three years

Population: The sampling frame for this study was consecutive COPD patients recruited from the outpatient clinic of Botucatu Medical School.

FEV1 values were measured by Spirometry using the KOKO Spirometer, before and 15 minutes after the inhalation of 400mcg of salbutamol.

Outcome measures

Measure	Chronic Obstructive Pulmonary Disease Markers Over Three Years n=95 Participants All patients were evaluated at baseline and attended at the clinics every six months for three years or until death.
Forced Expiratory Volume in the First Second (FEV1) Baseline assessment	54 Percentage predicted Interval 41.0 to 73.0
Forced Expiratory Volume in the First Second (FEV1) After three-year assessment	54 Percentage predicted Interval 40.0 to 70.0

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Chronic Obstructive Pulmonary Disease Markers Over Three Years n=95 Participants All patients were evaluated at baseline and attended at the clinics every six months for three years or until death.
Exercise Tolerance Baseline assessment	438 meters Standard Deviation 86
Exercise Tolerance After three-year assessment	412 meters Standard Deviation 100

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Chronic Obstructive Pulmonary Disease Markers Over Three Years n=95 Participants All patients were evaluated at baseline and attended at the clinics every six months for three years or until death.
Body Composition Baseline assessment	25 Kg/m^2 Interval 22.0 to 29.0
Body Composition After three-year assessment	25 Kg/m^2 Interval 22.0 to 29.0

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Chronic Obstructive Pulmonary Disease Markers Over Three Years n=95 Participants All patients were evaluated at baseline and attended at the clinics every six months for three years or until death.
Dyspnea Baseline assessment	1 Scores on a scale Interval 1.0 to 2.0
Dyspnea After three-year assessment	2 Scores on a scale Interval 1.0 to 3.0

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Chronic Obstructive Pulmonary Disease Markers Over Three Years n=95 Participants All patients were evaluated at baseline and attended at the clinics every six months for three years or until death.
Health Status Baseline assessment	42 Percentage of total score Standard Deviation 19
Health Status After three-year assessment	44 Percentage of total score Standard Deviation 19

Adverse Events

Chronic Obstructive Pulmonary Disease

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Renata Ferrari

HC/FMB-Unesp

Phone: 55 14 38116213

Email: renataferrarifisio@gmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place