COPDNCT01888705
Complexity of the Airflow in COPD
An observational study of COPD, run by Rio de Janeiro State University at 1 site in Brazil.
Trial summary
Recently, there has been a growing interest in the study of nonlinear dynamics as a methodology for complementary analysis to characterize the respiratory pattern. These methods are well established in studies of heart rate. Read more about this study
- Who is it for?
- Ages 40 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- COPD
- Type of treatment
- Injection or infusion
- How many people
- 90 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2010to Dec 2013
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
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 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The control group will consist of healthy subjects, nonsmokers, who had no episode of respiratory infection thirty days before the examinations. The group of patients with COPD will be comprised of individuals treated at the Department of Pneumology (Hospital Universitário Pedro Ernesto), at different levels of airflow obstruction.
Who may be able to join
- volunteers with COPD for Patients Group;
- volunteers without any respiratory disease for the control group.
Who cannot join
- individuals with history of tuberculosis or other lung disease,
- heart disease in general and
- disability in the exams.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Laboratório de Instrumentação Biomédica
Rio de Janeiro, Rio de Janeiro, 21550-013
Karla Dames, Principal Investigator, : (5521)97456496, kkdames@gmail.com
Karla Dames, MSc.
About this study
Official title: Complexity of the Airflow at Different Levels of Bronchial Obstruction of COPD.
Recently, there has been a growing interest in the study of nonlinear dynamics as a methodology for complementary analysis to characterize the respiratory pattern. These methods are well established in studies of heart rate. The analyzes evaluate complex signals, including large-scale fractal correlations and distributions in time series, and can provide relevant clinical information.
Measures such as approximate entropy and sample entropy have shown great potential in the evaluation of the complexity of the respiratory system, providing information relevant to the understanding of physiological and pathophysiological processes. These measures are based on the concept of non-linearity in the presence of a high number of interconnections, resulting in the complex behavior exhibited by physiological systems.
Read more
The approximate entropy (ApEn) is related to the amount of clutter, complexity or unpredictability of a data series over time. In a complementary way, the sample entropy (SampEn), is a far more elaborate than the ApEn, to reduce possible biased estimates due to self-similarity.
A study conducted by our group in asthma patients with different levels of bronchial obstruction demonstrated a significant reduction in airflow approximate entropy (ApEnV´) in asthmatic subjects. Investigators believe that in COPD, similar to that which occurs in asthma disorders that are associated with complex changes in the pathophysiology triggering breath control, possibly resulting in changes in air flow (V´).
Considering the development "silent" changes of mechanical ventilation in COPD patients and its clinical relevance, as well as the difficulty of identifying such changes through conventional methods, we observed the need to obtain more detailed information, including the complexity of the system breathing for better understanding of factors that contribute to the illness.
In this context, the objectives of this study were: (1) analyze the influence of airway obstruction in the complexity of the patterns of airflow in patients with COPD, (2) evaluate the diagnostic power of the test in identifying the changes caused by COPD.
- Conditions
- COPD
- Keywords
- COPD, Complexity, Entropy Sampling, Variability, Respiratory Mechanics, FOT
- 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 |
|---|---|---|
| Control group | Group of nonsmokers individuals without respiratory disease. | |
| NE | Smokers wiht normal spirometry. | |
| LV | Patients with COPD level I, mild. | |
| MOD | Patients with COPD level II, moderate. | |
| GV | Patients with COPD level III, severe. | |
| MGV | Patients with COPD level IV, very severe. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory Impedance in Different Phases of the Cycle Ventilation in Patients with Chronic Obstructive Pulmonary Disease
The aim of the study was to analyze the changes in the respiratory system impedance (Zrs) in the different phases of the respiratory cycle of patients with Chronic Obstructive Pulmonary Disease (COPD). This research was conducted using a monofrequency version of the forced oscillation technique (mFOT) and consisted of a controlled observational study where 31 individuals were analyzed, 8 controls and 23 individuals with COPD. The patients presented different degrees of airway obstruction.
Measured: up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2013 (estimated)
- Study startMar 2010
- Primary completionJul 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COPDStudies 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
- Time perspective
- Cross-sectional
- Enrolment
- 90 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Rio de Janeiro State University
- Sponsor type
- University, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico, Rio de Janeiro State Research Supporting Foundation (FAPERJ)
- Responsible party
- Principal investigator, Karla Dames, Rio de Janeiro State University
- Investigators
- Pedro L de Melo, DSc., Study director, State University of Rio de Janeiro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01888705
- Sponsor's protocol ID
- UERJ-DPOC-01
- Status last verified
- Jun 2013
- First submitted
- 21 Jun 2013
- Last updated
- 28 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Silva KK, Faria AC, Lopes AJ, Melo PL. Within-breath respiratory impedance and airway obstruction in patients with chronic obstructive pulmonary disease. Clinics (Sao Paulo). 2015 Jul;70(7):461-9. doi: 10.6061/clinics/2015(07)01. Epub 2015 Jul 1.
PubMed 26222814
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Complexity of the Airflow at Different Levels of Bronchial Obstruction of COPD.
- ClinicalTrials.gov ID
- NCT01888705
- Acronym / sponsor ID
- UERJ-DPOC-01
- Conditions
- COPD
- Keywords
- COPD, Complexity, Entropy Sampling, Variability, Respiratory Mechanics, FOT
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Rio de Janeiro State UniversityUniversity, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico, Rio de Janeiro State Research Supporting Foundation (FAPERJ)
- Study start
- Mar 2010
- Primary completion
- Jul 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 28 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Recently, there has been a growing interest in the study of nonlinear dynamics as a methodology for complementary analysis to characterize the respiratory pattern. These methods are well established in studies of heart rate. The analyzes evaluate complex signals, including large-scale fractal correlations and distributions in time series, and can provide relevant clinical information.
Measures such as approximate entropy and sample entropy have shown great potential in the evaluation of the complexity of the respiratory system, providing information relevant to the understanding of physiological and pathophysiological processes. These measures are based on the concept of non-linearity in the presence of a high number of interconnections, resulting in the complex behavior exhibited by physiological systems.
The approximate entropy (ApEn) is related to the amount of clutter, complexity or unpredictability of a data series over time. In a complementary way, the sample entropy (SampEn), is a far more elaborate than the ApEn, to reduce possible biased estimates due to self-similarity.
A study conducted by our group in asthma patients with different levels of bronchial obstruction demonstrated a significant reduction in airflow approximate entropy (ApEnV´) in asthmatic subjects. Investigators believe that in COPD, similar to that which occurs in asthma disorders that are associated with complex changes in the pathophysiology triggering breath control, possibly resulting in changes in air flow (V´).
Considering the development "silent" changes of mechanical ventilation in COPD patients and its clinical relevance, as well as the difficulty of identifying such changes through conventional methods, we observed the need to obtain more detailed information, including the complexity of the system breathing for better understanding of factors that contribute to the illness.
In this context, the objectives of this study were: (1) analyze the influence of airway obstruction in the complexity of the patterns of airflow in patients with COPD, (2) evaluate the diagnostic power of the test in identifying the changes caused by COPD.
Study design
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Control group | – | –Group of nonsmokers individuals without respiratory disease. |
| NE | – | –Smokers wiht normal spirometry. |
| LV | – | –Patients with COPD level I, mild. |
| MOD | – | –Patients with COPD level II, moderate. |
| GV | – | –Patients with COPD level III, severe. |
| MGV | – | –Patients with COPD level IV, very severe. |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The control group will consist of healthy subjects, nonsmokers, who had no episode of respiratory infection thirty days before the examinations. The group of patients with COPD will be comprised of individuals treated at the Department of Pneumology (Hospital Universitário Pedro Ernesto), at different levels of airflow obstruction.
Key inclusion criteria (2 listed)
- volunteers with COPD for Patients Group;
- volunteers without any respiratory disease for the control group.
Key exclusion criteria (3 listed)
- individuals with history of tuberculosis or other lung disease,
- heart disease in general and
- disability in the exams.
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
Respiratory Impedance in Different Phases of the Cycle Ventilation in Patients with Chronic Obstructive Pulmonary Disease
Time frame: up to 3 years
The aim of the study was to analyze the changes in the respiratory system impedance (Zrs) in the different phases of the respiratory cycle of patients with Chronic Obstructive Pulmonary Disease (COPD). This research was conducted using a monofrequency version of the forced oscillation technique (mFOT) and consisted of a controlled observational study where 31 individuals were analyzed, 8 controls and 23 individuals with COPD. The patients presented different degrees of airway obstruction.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2013.
- Derived from this study: PubMed 26222814Silva KK, Faria AC, Lopes AJ, Melo PL. Within-breath respiratory impedance and airway obstruction in patients with chronic obstructive pulmonary disease. Clinics (Sao Paulo). 2015 Jul;70(7):461-9. doi: 10.6061/clinics/2015(07)01. Epub 2015 Jul 1.
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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.
Pedro L de Melo, DSc. study director
State University of Rio de Janeiro
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 COPD, run by Rio de Janeiro State University 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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 28 Jun 2013. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respiratory Impedance in Different Phases of the Cycle Ventilation in Patients with Chronic Obstructive Pulmonary Disease (time frame: up to 3 years). 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 NCT01888705, which also lists 1 linked publication.
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 28 Jun 2013.