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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

Brazil1 site
  • University of São Paulo

    São Paulo, São Paulo, 05403-900

Other trials in Brazil

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:

  1. Primary
  • To evaluate the prevalence of dynamic hyperinflation in patients with bronchiectasis
  1. 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.
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 groups in NCT04234789
Study groupRoleWhat they receive
Cardiopulmonary exercising testOtherAll 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.

  1. 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.

  1. First posted21 Jan 2020
  2. Study startMay 2014
  3. Primary completionMay 2014
  4. Study completionOct 2017

Resources

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)
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

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.

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