Chronic Obstructive Pulmonary DiseaseNCT00605540
Chronic Obstructive Pulmonary Disease Markers and Prognosis
An observational study of Chronic Obstructive Pulmonary Disease, run by UPECLIN HC FM Botucatu Unesp at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 40 to 95 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- How many people
- 133 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2008to Feb 2012
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Pulmonary outpatient clinic
Who may be able to join
- COPD diagnosis according to the GOLD criteria
Who cannot join
- Asthma
- Inability to perform pulmonary function and exercise tolerance tests
- Recent myocardial infarction or unstable angina
- Congestive heart failure: class III/IV
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD, Survival, Exacerbation, Disease markers
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Study COPD population | Patients with diagnosis of mild to very severe chronic obstructive pulmonary disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and after three years
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.
Measured: Baseline and after three years
Body Composition
Body composition was evaluated by Body Mass Index (BMI), which is dividing weight in kilograms by height in square meters.
Measured: Baseline and after three years
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.
Measured: Baseline and after three years
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.
Measured: Baseline and after three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2008 (estimated)
- Study startJan 2008
- Primary completionMar 2010
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 133 participants (actual)
Sponsor and investigators
- Lead sponsor
- UPECLIN HC FM Botucatu Unesp
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Irma de Godoy, UPECLIN HC FM Botucatu Unesp
- Investigators
- Irma de Godoy, PhD, MD, Study chair, Botucatu School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00605540
- Sponsor's protocol ID
- upeclin/HC/FMB-Unesp-06
- Status last verified
- May 2014
- First submitted
- 18 Jan 2008
- Last updated
- 3 Sep 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Ferrari R, Tanni SE, Caram LM, Correa C, Correa CR, Godoy I. Three-year follow-up of Interleukin 6 and C-reactive protein in chronic obstructive pulmonary disease. Respir Res. 2013 Feb 20;14(1):24. doi: 10.1186/1465-9921-14-24.
PubMed 23425215Ferrari R, Tanni SE, Caram LM, Naves CR, Godoy I. Predictors of health status do not change over three-year periods and exacerbation makes difference in chronic obstructive pulmonary disease. Health Qual Life Outcomes. 2011 Dec 9;9:112. doi: 10.1186/1477-7525-9-112.
PubMed 22152155
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Three-years Follow-up of Diagnostic and Prognostic Markers in Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT00605540
- Acronym / sponsor ID
- upeclin/HC/FMB-Unesp-06
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD, Survival, Exacerbation, Disease markers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 133 participants (actual)
- Lead sponsor
- UPECLIN HC FM Botucatu UnespUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Mar 2010 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 31 Jan 2008 (estimated)
- Results
- Posted 3 Sep 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study COPD population | – | –Patients with diagnosis of mild to very severe chronic obstructive pulmonary disease |
Who may qualify
- Ages
- 40 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pulmonary outpatient clinic
Key inclusion criteria (1 listed)
- COPD diagnosis according to the GOLD criteria
Key exclusion criteria (4 listed)
- Asthma
- Inability to perform pulmonary function and exercise tolerance tests
- Recent myocardial infarction or unstable angina
- Congestive heart failure: class III/IV
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
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.
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23425215Ferrari R, Tanni SE, Caram LM, Correa C, Correa CR, Godoy I. Three-year follow-up of Interleukin 6 and C-reactive protein in chronic obstructive pulmonary disease. Respir Res. 2013 Feb 20;14(1):24. doi: 10.1186/1465-9921-14-24.
- Derived from this study: PubMed 22152155Ferrari R, Tanni SE, Caram LM, Naves CR, Godoy I. Predictors of health status do not change over three-year periods and exacerbation makes difference in chronic obstructive pulmonary disease. Health Qual Life Outcomes. 2011 Dec 9;9:112. doi: 10.1186/1477-7525-9-112.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Irma de Godoy, PhD, MD study chair
Botucatu School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease, run by UPECLIN HC FM Botucatu Unesp at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Sep 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Forced Expiratory Volume in the First Second (FEV1) (time frame: Baseline and after three years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00605540, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2014.