Bronchiectasis AdultNCT04234789
Predictors of Physical Activity Performance and Dynamic Hyperinflation in Patients With Bronchiectasis
A study testing cardiopulmonary exercise testing with dynamic hyperinflation maneuver, spirometry and pletysmography in people with Bronchiectasis Adult, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
Bronchiectasis is characterized by abnormal and irreversible airway dilation and can be caused by a wide variety of diseases, including congenital diseases, mechanical bronchial obstruction, respiratory infections, and immunodeficiencies. It is a chronic condition with varying severity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bronchiectasis Adult
- What is being tested?
- cardiopulmonary exercise testing with dynamic hyperinflation maneuver, spirometry and pletysmography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 208 participants
- Where
- 1 siteBrazil
- Study dates
- May 2014to Oct 2017
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients over 18 years of age followed at the Bronchiectasis Outpatient Clinic of the Pulmonology Department of the University of São Paulo who meet the following criteria will be included in the study:
- Have a diagnosis of bronchiectasis confirmed by chest CT.
- Sign the free and informed consent form for participation in the study.
Who cannot join
- Diagnosis of Cystic Fibrosis.
- Asthma diagnosis.
- Diagnosis of COPD.
- Pregnancy
- Inability to perform pulmonary function test.
- Recent treatment (<30 days) of infectious exacerbation with oral corticosteroid or antibiotic.
Show all 13Show fewer
- Contraindication to exercise tests.
- Exercise limitation not related to lung disease (orthopedic or cardiovascular problems).
- History of pulmonary resection.
- Current smoking or previous smoking load greater than 10 years / pack.
- Patients on prolonged home oxygen therapy.
- Allergic bronchopulmonary aspergillosis.
- Active mycobacteriosis.
Trial locations and contacts
1 site in 1 country.
About this study
Bronchiectasis is characterized by abnormal and irreversible airway dilation and can be caused by a wide variety of diseases, including congenital diseases, mechanical bronchial obstruction, respiratory infections, and immunodeficiencies. It is a chronic condition with varying severity. Although some patients remain stable for years, the natural history of the disease is progressive deterioration of lung function, Regarding pulmonary function in this group of patients, there are several changes. In a study of 304 patients with bronchiectasis, spirometry was performed in 274 patients. Most of these patients (46.7%) had an obstructive ventilatory disorder, a small percentage of patients (8%) had restrictive disorder and a portion of patients (23.7%) had mixed disorder. The remaining patients (21.5%) had normal spirometry. Dyspnea in this situation occurs due to neuromechanical dissociation, that is, the respiratory drive is increased, but the inspiratory muscles show a reduction in their ability to produce effective ventilation. Besides not knowing if dynamic hyperinflation (DH) is present in patients with bronchiectasis, the mechanism responsible for its onset is also unknown. Exercise capacity is reduced in many patients with bronchiectasis, but there is little information about the exercise response in this population.
The primary objective of this study is to evaluate the prevalence of dynamic hyperinflation in patients with bronchiectasis
Read the detailed description
Bronchiectasis is characterized by abnormal and irreversible airway dilation and can be caused by a wide variety of diseases, including congenital diseases, mechanical bronchial obstruction, respiratory infections, and immunodeficiencies.
It is a chronic condition with varying severity. Although some patients remain stable for years, the natural history of the disease is progressive deterioration of lung function, chronic respiratory failure, pulmonary hypertension, and right ventricular failure.
Bronchiectasis is a consequence of injury and remodeling with destruction of structural components of the bronchial wall by inflammation and chronic or recurrent infection.The best-known model of developing bronchiectasis is the hypothesis of Cole's vicious cycle. An environmental insult associated with a genetic predisposition impairs mucociliary transport resulting in persistence of microorganisms in the bronchial tree. The infection causes inflammation resulting in tissue damage and further impairing ciliary motility. This leads to further infection, inflammation and lung damage.The patient with bronchiectasis has a cough, chronic sputum, hemoptysis and progressive dyspnea. The clinical course is marked by recurrent infectious exacerbations and over time the patient develops progressive airway obstruction with functional loss.
Regarding pulmonary function in this group of patients, there are several changes. In a study of 304 patients with bronchiectasis, spirometry was performed in 274 patients. Most of these patients (46.7%) had an obstructive ventilatory disorder, a small percentage of patients (8%) had restrictive disorder and a portion of patients (23.7%) had mixed disorder. The remaining patients (21.5%) had normal spirometry.
Dynamic hyperinflation (DH) is characterized by progressive air trapping, which leads to increased end-expiratory lung volume (equivalent to dynamic functional residual capacity) associated with decreased inspiratory capacity (IC) in situations where ventilation is increased, such as exercise. . Dynamic hyperinflation is one of the mechanisms responsible for dyspnea and reduced exercise tolerance in patients with conditions that lead to expiratory flow limitation, such as asthma and COPD.
Studies evaluating dynamic hyperinflation were performed in chronic obstructive pulmonary disease (COPD) patients, demonstrating that the progressive reduction of IC during the maximal or constant load test, on the treadmill or on the cycle ergometer, or through measurements performed before and after the test. The 6-minute walk showed a good correlation with the degree of dyspnea (including the Borg scale) and lower exercise tolerance . Since the total lung capacity (TLC) does not vary or has little non-significant variation during exercise or after bronchodilation, the reduction in IC reflects increased end-expiratory lung volume (VPFE) . In COPD patients, the prevalence of DH is high, around 80% in patients with an average forced expiratory volume in first second (FEV1) of 37%, according to a 2001 study. Asthmatic patients, even with normal spirometry, stable clinical status and no exercise-induced asthma may present limitation to expiratory flow and dynamic hyperinflation during exertion, justifying the presence of dyspnea and less ability to perform exercises In individuals with expiratory flow limitation, the additional elevation of tidal volume (VT) on exertion is limited because operative lung volumes are progressively closer to TLC, in a higher region of the pressure volume curve, where pulmonary compliance is lower. Secondarily, there is a reduction in inspiratory reserve volume (VRI) and, when this volume approaches 500 ml (critical VRI), dyspnea increases considerably, being referred to as inspiratory difficulty. The increase in minute volume is now determined by increased respiratory rate (RR), which further aggravates the situation due to reduced expiratory time (ET), with less time available for elimination of previously inhaled air volume, causing progressive air trapping and worsening pulmonary hyperinflation, entering a vicious cycle (9,10,13,21). Additionally, this mechanism promotes increased elastic overload on the inspiratory muscles by shortening the fibers, reducing their capacity to generate force, determining increased respiratory work, oxygen consumption and the risk of muscle fatigue, as well as adverse hemodynamic effects . Dyspnea in this situation occurs due to neuromechanical dissociation, that is, the respiratory drive is increased, but the inspiratory muscles show a reduction in their ability to produce effective ventilation.
The most commonly used option for dynamic hyperinflation assessment is the serial measurement of IC during maneuvers that promote hyperventilation, such as by performing an incremental or constant-load stress test on the cycle ergometer or treadmill, performing the 6-minute test..
Besides not knowing if DH is present in patients with bronchiectasis, the mechanism responsible for its onset is also unknown. Exercise capacity is reduced in many patients with bronchiectasis, but there is little information about the exercise response in this population. A study was published in 2009 investigating exercise capacity and possible exercise limiting factors in patients with bilateral bronchiectasis. Approximately 50% of patients had reduced exercise capacity, and this was observed in those who had expiratory flow limitation and reduced FEV1 values. Ventilatory limitation, desaturation, and impaired oxygen transport or utilization appear to be the main factors involved in exercise limitation. However, the sample was very small (15 patients) and no DH evaluation was performed.
There are no studies evaluating the presence of DH in patients with bronchiectasis and there are few studies on the physiology of dyspnea in this population. DH is an important mechanism of exercise limitation in COPD and may explain exercise dyspnea and decreased exercise tolerance in patients with bronchiectasis.
Study hypothesis:
Dynamic hyperinflation is present in patients with bronchiectasis.
Objectives:
- Primary
- To evaluate the prevalence of dynamic hyperinflation in patients with bronchiectasis
- Secondary
- Evaluate aerobic capacity in a population with bronchiectasis
- To evaluate predictors of dynamic hyperinflation and aerobic limitation in patients with bronchiectasis. Anthropometric data, clinical, functional and tomographic variables will be evaluated.
- Conditions
- Bronchiectasis Adult
- Being tested
- cardiopulmonary exercise testing with dynamic hyperinflation maneuver, spirometry, pletysmography, forced oscillometry technique
- Keywords
- dynamic hyperinflation, oscillometry, pletysmography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cardiopulmonary exercise testing with dynamic hyperinflation maneuverDiagnostic test
test performed as recommended by ATS guidelines
spirometryDiagnostic test
test performed as recommended by ATS guidelines
pletysmographyDiagnostic test
test performed as recommended by ATS guidelines
forced oscillometry techniqueDiagnostic test
test performed as recommended by ATS guidelines
| Study group | Role | What they receive |
|---|---|---|
| Cardiopulmonary exercising test | Other | All patients underwent to diagnostic tests protocol Receives: Diagnostic Test: cardiopulmonary exercise testing with dynamic hyperinflation maneuver; Diagnostic Test: spirometry; Diagnostic Test: pletysmography; Diagnostic Test: forced oscillometry technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of dynamic hyperinflation during cardiopulmonary exercise testing
During cardiopulmonary exercising testing, patients were asked to perform inspiratory capacity maneuvers every 2 minutes. Dynamic hyperinflation was considered as present when the patient had a reduction of 10% or more of the inspiratory capacity.
Measured: Day 1 (single visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2020
- Study startMay 2014
- Primary completionMay 2014
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bronchiectasis AdultStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Cross-sectional study. All patients underwent to diagnostic tests protocol.
- Masking
- None (open label)
- Enrolment
- 208 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Sponsor
- Investigators
- Rodrigo A Athanazio, MD, PhD, Principal investigator, Medical Assistant
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04234789
- Sponsor's protocol ID
- SDC 4245/15/072
- Other IDs
- 2015/14638-2, 2015
- Status last verified
- Jan 2020
- First submitted
- 8 Jan 2020
- Last updated
- 21 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of Physical Activity Performance and Dynamic Hyperinflation in Patients With Bronchiectasis
- ClinicalTrials.gov ID
- NCT04234789
- Acronym / sponsor ID
- SDC 4245/15/072
- Conditions
- Bronchiectasis Adult
- Keywords
- dynamic hyperinflation, oscillometry, pletysmography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 208 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- May 2014 (actual)
- Primary completion
- May 2014 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 21 Jan 2020 (actual)
- 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.
Bronchiectasis is characterized by abnormal and irreversible airway dilation and can be caused by a wide variety of diseases, including congenital diseases, mechanical bronchial obstruction, respiratory infections, and immunodeficiencies. It is a chronic condition with varying severity. Although some patients remain stable for years, the natural history of the disease is progressive deterioration of lung function, Regarding pulmonary function in this group of patients, there are several changes. In a study of 304 patients with bronchiectasis, spirometry was performed in 274 patients. Most of these patients (46.7%) had an obstructive ventilatory disorder, a small percentage of patients (8%) had restrictive disorder and a portion of patients (23.7%) had mixed disorder. The remaining patients (21.5%) had normal spirometry. Dyspnea in this situation occurs due to neuromechanical dissociation, that is, the respiratory drive is increased, but the inspiratory muscles show a reduction in their ability to produce effective ventilation. Besides not knowing if dynamic hyperinflation (DH) is present in patients with bronchiectasis, the mechanism responsible for its onset is also unknown. Exercise capacity is reduced in many patients with bronchiectasis, but there is little information about the exercise response in this population.
The primary objective of this study is to evaluate the prevalence of dynamic hyperinflation in patients with bronchiectasis
Detailed description
Bronchiectasis is characterized by abnormal and irreversible airway dilation and can be caused by a wide variety of diseases, including congenital diseases, mechanical bronchial obstruction, respiratory infections, and immunodeficiencies.
It is a chronic condition with varying severity. Although some patients remain stable for years, the natural history of the disease is progressive deterioration of lung function, chronic respiratory failure, pulmonary hypertension, and right ventricular failure.
Bronchiectasis is a consequence of injury and remodeling with destruction of structural components of the bronchial wall by inflammation and chronic or recurrent infection.The best-known model of developing bronchiectasis is the hypothesis of Cole's vicious cycle. An environmental insult associated with a genetic predisposition impairs mucociliary transport resulting in persistence of microorganisms in the bronchial tree. The infection causes inflammation resulting in tissue damage and further impairing ciliary motility. This leads to further infection, inflammation and lung damage.The patient with bronchiectasis has a cough, chronic sputum, hemoptysis and progressive dyspnea. The clinical course is marked by recurrent infectious exacerbations and over time the patient develops progressive airway obstruction with functional loss.
Regarding pulmonary function in this group of patients, there are several changes. In a study of 304 patients with bronchiectasis, spirometry was performed in 274 patients. Most of these patients (46.7%) had an obstructive ventilatory disorder, a small percentage of patients (8%) had restrictive disorder and a portion of patients (23.7%) had mixed disorder. The remaining patients (21.5%) had normal spirometry.
Dynamic hyperinflation (DH) is characterized by progressive air trapping, which leads to increased end-expiratory lung volume (equivalent to dynamic functional residual capacity) associated with decreased inspiratory capacity (IC) in situations where ventilation is increased, such as exercise. . Dynamic hyperinflation is one of the mechanisms responsible for dyspnea and reduced exercise tolerance in patients with conditions that lead to expiratory flow limitation, such as asthma and COPD.
Studies evaluating dynamic hyperinflation were performed in chronic obstructive pulmonary disease (COPD) patients, demonstrating that the progressive reduction of IC during the maximal or constant load test, on the treadmill or on the cycle ergometer, or through measurements performed before and after the test. The 6-minute walk showed a good correlation with the degree of dyspnea (including the Borg scale) and lower exercise tolerance . Since the total lung capacity (TLC) does not vary or has little non-significant variation during exercise or after bronchodilation, the reduction in IC reflects increased end-expiratory lung volume (VPFE) . In COPD patients, the prevalence of DH is high, around 80% in patients with an average forced expiratory volume in first second (FEV1) of 37%, according to a 2001 study. Asthmatic patients, even with normal spirometry, stable clinical status and no exercise-induced asthma may present limitation to expiratory flow and dynamic hyperinflation during exertion, justifying the presence of dyspnea and less ability to perform exercises In individuals with expiratory flow limitation, the additional elevation of tidal volume (VT) on exertion is limited because operative lung volumes are progressively closer to TLC, in a higher region of the pressure volume curve, where pulmonary compliance is lower. Secondarily, there is a reduction in inspiratory reserve volume (VRI) and, when this volume approaches 500 ml (critical VRI), dyspnea increases considerably, being referred to as inspiratory difficulty. The increase in minute volume is now determined by increased respiratory rate (RR), which further aggravates the situation due to reduced expiratory time (ET), with less time available for elimination of previously inhaled air volume, causing progressive air trapping and worsening pulmonary hyperinflation, entering a vicious cycle (9,10,13,21). Additionally, this mechanism promotes increased elastic overload on the inspiratory muscles by shortening the fibers, reducing their capacity to generate force, determining increased respiratory work, oxygen consumption and the risk of muscle fatigue, as well as adverse hemodynamic effects . Dyspnea in this situation occurs due to neuromechanical dissociation, that is, the respiratory drive is increased, but the inspiratory muscles show a reduction in their ability to produce effective ventilation.
The most commonly used option for dynamic hyperinflation assessment is the serial measurement of IC during maneuvers that promote hyperventilation, such as by performing an incremental or constant-load stress test on the cycle ergometer or treadmill, performing the 6-minute test..
Besides not knowing if DH is present in patients with bronchiectasis, the mechanism responsible for its onset is also unknown. Exercise capacity is reduced in many patients with bronchiectasis, but there is little information about the exercise response in this population. A study was published in 2009 investigating exercise capacity and possible exercise limiting factors in patients with bilateral bronchiectasis. Approximately 50% of patients had reduced exercise capacity, and this was observed in those who had expiratory flow limitation and reduced FEV1 values. Ventilatory limitation, desaturation, and impaired oxygen transport or utilization appear to be the main factors involved in exercise limitation. However, the sample was very small (15 patients) and no DH evaluation was performed.
There are no studies evaluating the presence of DH in patients with bronchiectasis and there are few studies on the physiology of dyspnea in this population. DH is an important mechanism of exercise limitation in COPD and may explain exercise dyspnea and decreased exercise tolerance in patients with bronchiectasis.
Study hypothesis:
Dynamic hyperinflation is present in patients with bronchiectasis.
Objectives:
- Primary
- To evaluate the prevalence of dynamic hyperinflation in patients with bronchiectasis
- Secondary
- Evaluate aerobic capacity in a population with bronchiectasis
- To evaluate predictors of dynamic hyperinflation and aerobic limitation in patients with bronchiectasis. Anthropometric data, clinical, functional and tomographic variables will be evaluated.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Cross-sectional study. All patients underwent to diagnostic tests protocol.
| Arm | Type | Receives |
|---|---|---|
| Cardiopulmonary exercising test | Other | Diagnostic Test: cardiopulmonary exercise testing with dynamic hyperinflation maneuver, Diagnostic Test: spirometry, Diagnostic Test: pletysmography, Diagnostic Test: forced oscillometry techniqueAll patients underwent to diagnostic tests protocol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients over 18 years of age followed at the Bronchiectasis Outpatient Clinic of the Pulmonology Department of the University of São Paulo who meet the following criteria will be included in the study:
- Have a diagnosis of bronchiectasis confirmed by chest CT.
- Sign the free and informed consent form for participation in the study.
Key exclusion criteria (13 listed)
- Diagnosis of Cystic Fibrosis.
- Asthma diagnosis.
- Diagnosis of COPD.
- Pregnancy
- Inability to perform pulmonary function test.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cardiopulmonary exercise testing with dynamic hyperinflation maneuvertest performed as recommended by ATS guidelines | Diagnostic test | Cardiopulmonary exercising test |
| spirometrytest performed as recommended by ATS guidelines | Diagnostic test | Cardiopulmonary exercising test |
| pletysmographytest performed as recommended by ATS guidelines | Diagnostic test | Cardiopulmonary exercising test |
| forced oscillometry techniquetest performed as recommended by ATS guidelines | Diagnostic test | Cardiopulmonary exercising test |
Primary outcome
Prevalence of dynamic hyperinflation during cardiopulmonary exercise testing
Time frame: Day 1 (single visit)
During cardiopulmonary exercising testing, patients were asked to perform inspiratory capacity maneuvers every 2 minutes. Dynamic hyperinflation was considered as present when the patient had a reduction of 10% or more of the inspiratory capacity.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2020.
- Individual participant dataSharing planned: No
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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.
Rodrigo A Athanazio, MD, PhD principal investigator
Medical Assistant
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cardiopulmonary exercise testing with dynamic hyperinflation maneuver, spirometry and pletysmography in people with Bronchiectasis Adult, run by University of Sao Paulo General Hospital 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 3 inclusion and 13 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 21 Jan 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Prevalence of dynamic hyperinflation during cardiopulmonary exercise testing (time frame: Day 1 (single visit)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Jan 2020.