BronchiectasisNCT02509637
Acute Effects of a Flutter Device and Chest Wall Compression on Respiratory System Impedance in Bronchiectasis Patients
A study testing Flutter, Chest Compression and Impulse Oscillometric in people with Bronchiectasis, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
Bronchiectasis is characterized pathologically by the abnormal and permanent dilation of bronchi caused mainly by the perpetuation of inflammation and impaired clearance of secretions. Physical therapy is essential in the treatment of these patients, using its various techniques and devices. Read more about this study
- Who is it for?
- Ages 30 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Bronchiectasis
- What is being tested?
- Flutter, Chest Compression and Impulse Oscillometric
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2015to Sep 2016
- 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 30 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- aged between 30 and 80 years
- diagnosed with bronchiectasis not resulting from cystic fibrosis, defined by history and full clinical examination and confirmed by computed tomography.
Who cannot join
- Chest pain
- acute hemoptysis
- recent history rib fracture and pneumothorax
- respiratory infection in the last 4 weeks prior to study
- cystic fibrosis
- asthma
- fistula.
- chronic obstructive pulmonary disease
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Ribeirão Preto Medicine School, University of São Paulo
Ribeirão Preto, São Paulo, 14049-900
About this study
Bronchiectasis is characterized pathologically by the abnormal and permanent dilation of bronchi caused mainly by the perpetuation of inflammation and impaired clearance of secretions. Physical therapy is essential in the treatment of these patients, using its various techniques and devices. The aim of this study is to evaluate the impedance of the respiratory system, by impulse oscillometry, after breathing exercises with chest compression or flutter in patients with bronchiectasis, considering that there are no results in the literature on the effect of these techniques in the small airways of these patients.
Read the detailed description
Bronchiectasis patients and healthy subjects will be evaluated before and after a 30 minutes session of control, breathing exercises with flutter valve, that is a device that produces oscillation and positive pressure during the expiratory phase, or chest compression, that is a manual manoeuvre in the right and left sides of the lower chest, all of them in a sitting position. The main outcome will be obtained by impulse oscillometry, that is a method to access large and small airways, to evaluate the resistance (R), reactance (X), reactance area (AX) and resonant frequency (Fres) of respiratory system for the whole breath and for inspiratory and expiratory phase. Additionally, will be analysed the dyspnea using the Medical Research Council scale; acceptability and tolerability scale; pulse oxymetry; difficulty of expectoration score; and volume, adhesivity and purulence of sputum.
- Conditions
- Bronchiectasis
- Being tested
- Flutter, Chest Compression, Control, Impulse Oscillometric, Dyspnea scale
- Keywords
- Respiratory System, Physical Therapy Modalities
- Medical subject headings
- Bronchiectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FlutterDevice
Flutter is a small device, simple, like a plastic pipe with a mouthpiece at one end and a perforated cover on the other, containing a steel ball resting in a plastic cone inside. When the patient exhales through the flutter expiratory flow causes movement of the ball, creating an oscillatory positive pressure.
Chest CompressionOther
Manual chest compression is based on the application of forces resulting from the action of respiratory muscles or physiotherapist manual action in order to increase the alveolar pressure creating a pressure gradient to promote change in pulmonary flow and volume.It consists of vigorous compression of the chest at the beginning of expiration or during expiration.
ControlOther
Impulse OscillometricOther
For this measure will be used IOS Jaeger (Jaeger, Wurzburg, Germany). to minimize the effect of the bad positioning of the tongue will use a mouth "free-flow", which contains a depressant for keeping the tongue in the mouth soil, stabilizing it and reducing oral resistance. Volunteers will support hands firmly on the cheeks to reduce the effect of oscillation thereof. The measures will be carried out with the volunteer sitting, using nasal, relaxed and your head in neutral clip, breathing normally through the mouthpiece to his lips tightly sealed to prevent air leaks.
Dyspnea scaleOther
Dyspnea will be evaluated across the range Medical Research Council (MRC) for use in patients with chronic obstructive pulmonary disease in Brazil.
Acceptability and toleranceOther
patients will complete scales 1-7, 1: extremely and 7: none) on usefulness, ease to understand the instructions, easy to perform the exercises, degree of fatigue and discomfort
Pulse oximetryDevice
During therapy the patient will remain monitored with digital oximeter and the information will be recorded before and after the procedures
Difficulty sputumOther
Patients inform the ease or difficulty sputum according to a scale of 1 to 5, where 1 = no difficulty and 5 = extremely difficult.
| Study group | Role | What they receive |
|---|---|---|
| Flutter Intervention | Active comparator | After initial evaluation, the subjects will perform breathing exercises with quiet inspiration and prolonged expiration on the device for thirty minutes, with breaks of one minute every four minutes. Immediately after the exercise will be performed new assessment against Impulse Oscillometry. Then patients will be kept for 30 minutes at rest and at the end will be applied the acceptability and tolerance scale and a third evaluation with Impulse Oscillometry. The secretions expectorated during the protocol will be evaluated for weight, adhesiveness and purulence. Receives: Device: Flutter; Other: Impulse Oscillometric; Other: Dyspnea scale; Other: Acceptability and tolerance; Device: Pulse oximetry; Other: Difficulty sputum |
| Chest Compression Intervention | Active comparator | After initial evaluation, the subjects will be instructed to perform deep breaths between three quiet inspiration brought, and expiration will be accompanied by bilateral compression with the therapist's hands on the lower ribs during thirty minutes with one minute intervals of rest every four minutes. Immediately after the exercise will be performed new assessment against Impulse Oscillometry. Then patients will be kept for 30 minutes at rest and at the end will be applied the acceptability and tolerance scale and a third evaluation with Impulse Oscillometry. The secretions expectorated during the protocol will be evaluated for weight, adhesiveness and purulence. Receives: Other: Chest Compression; Other: Impulse Oscillometric; Other: Dyspnea scale; Other: Acceptability and tolerance; Device: Pulse oximetry; Other: Difficulty sputum |
| Crontrol Intervention | Active comparator | After initial evaluation, patients will be remain seated quiet breathing without any guidance for thirty minutes. Immediately after this time will be held reassessment with Impulse Oscillometry. Then patients will be kept for 30 minutes at rest and at the end will be applied to acceptance and tolerance scale and a third evaluation with Impulse Oscillometry. The secretions expectorated during the protocol will be evaluated for wight, adhesiveness and purulence. Receives: Other: Control; Other: Impulse Oscillometric; Other: Dyspnea scale; Other: Acceptability and tolerance; Device: Pulse oximetry; Other: Difficulty sputum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory System Impedance
Will be evaluated the resistance (R), reactance (X), reactance area (AX) and resonance frequency (Fres) before, immediately after the intervention and after 30 minutes of rest in order of identifying changes in the components of resistance of airways of individuals.
Measured: In the primary evaluation, and after seven and fourteen days.
Difficulty sputum
Patients inform the ease or difficulty in expectoration in accordance with a scale of 1 to 5, where 1 = no difficulty and 5 = extremely difficult. (Burioka, 1998). The scale will be applied at baseline and always after the intervention to assess whether there is difference in the difficulty of sputum between sessions.
Measured: In the primary evaluation, and after seven and fourteen days.
Secretions weight
The secretions are collected in the universal and heavy collectors on a precision balance.They will be evaluated in the total weight measurements and a dry weight and wet mucus. The weight of mucus of each interventions are compared to determine a technique with improved efficiency for removal of secretions.
Measured: In the primary evaluation, and after seven and fourteen days.
Secondary outcomes (4)
Pulse oximetry
During therapy the patient will remain monitored with digital oximeter and the information will be recorded before and after the procedures
Measured: In the primary evaluation, and after seven and fourteen days.
Acceptability and tolerance
30 minutes after the treatment session or control, patients will complete scales 1-7, 1: extremely and 7: none) on usefulness, ease to understand the instructions, easy to perform the exercises, degree of fatigue and discomfort (adapted EATON, 2007).
Measured: In the primary evaluation, and after seven and fourteen days.
Dyspnea scale:
Dyspnea will be evaluated across the range Medical Research Council (MRC) for use in patients with chronic obstructive pulmonary disease in Brazil. The MRC scale comprises only five items, and the patient chooses the item corresponding to as dyspnea limits their activities of daily living. The patient reports its subjective degree of dyspnea choosing a value ranging from 1 to 5, with 1 (only suffers from shortness of breath during intense exercise), 2 (suffers from shortness of breath when walking briskly or climbing a slight slope) 3 (walks slower than people of the same age because of breathlessness or has to stop for breath even when walking slowly), 4 (stops for breath after walking less than 100 m or after a few minutes) and 5 (feel so short of breath that does not go over the house, or feel short of breath when getting dressed) (KOLEVIS et al., 2008).
Measured: In the primary evaluation, and after seven and fourteen days.
Adhesiveness of expectorated secretion:
Immediately after the separation of secretion with saliva, mucus will be evaluated for its adhesion award a note according to visual scale described by Lopez-Vidriero et al., 1973. Test samples giving the adhesive index between 1 (fully adhered) and 2 (small movement under gravity) will be classified as adhesive and between 3 (slow moving mass) and 4 (easy handling) will be classified as non-adhesive.
Measured: In the primary evaluation, and after seven and fourteen days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2015 (estimated)
- Study startAug 2015
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for BronchiectasisStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ada Clarice Gastaldi, University of Sao Paulo
- Investigators
- Ada C Gastaldi, PhD, Principal investigator, Ribeirão Preto Medicine School - University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02509637
- Sponsor's protocol ID
- USP 2015-3
- Status last verified
- Feb 2017
- First submitted
- 3 Jul 2015
- Last updated
- 23 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Tambascio J, de Souza LT, Lisboa RM, Passarelli Rde C, de Souza HC, Gastaldi AC. The influence of Flutter(R)VRP1 components on mucus transport of patients with bronchiectasis. Respir Med. 2011 Sep;105(9):1316-21. doi: 10.1016/j.rmed.2011.04.017.
PubMed 21641196Oostveen E, MacLeod D, Lorino H, Farre R, Hantos Z, Desager K, Marchal F; ERS Task Force on Respiratory Impedance Measurements. The forced oscillation technique in clinical practice: methodology, recommendations and future developments. Eur Respir J. 2003 Dec;22(6):1026-41. doi: 10.1183/09031936.03.00089403.
PubMed 14680096Murray MP, Pentland JL, Turnbull K, MacQuarrie S, Hill AT. Sputum colour: a useful clinical tool in non-cystic fibrosis bronchiectasis. Eur Respir J. 2009 Aug;34(2):361-4. doi: 10.1183/09031936.00163208.
PubMed 19648517McCarren B, Alison JA, Herbert RD. Manual vibration increases expiratory flow rate via increased intrapleural pressure in healthy adults: an experimental study. Aust J Physiother. 2006;52(4):267-71. doi: 10.1016/s0004-9514(06)70006-x.
PubMed 17132121Eaton T, Young P, Zeng I, Kolbe J. A randomized evaluation of the acute efficacy, acceptability and tolerability of flutter and active cycle of breathing with and without postural drainage in non-cystic fibrosis bronchiectasis. Chron Respir Dis. 2007;4(1):23-30. doi: 10.1177/1479972306074481.
PubMed 17416150de Souza Simoni LH, Dos Santos DO, de Souza HCD, Baddini-Martinez JA, Santos MK, Gastaldi AC. Acute Effects of Oscillatory PEP and Thoracic Compression on Secretion Removal and Impedance of the Respiratory System in Non-Cystic Fibrosis Bronchiectasis. Respir Care. 2019 Jul;64(7):818-827. doi: 10.4187/respcare.06025. Epub 2019 May 28.
PubMed 31138732
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects of a Flutter Device and Chest Wall Compression on Respiratory System Impedance in Bronchiectasis Patients
- ClinicalTrials.gov ID
- NCT02509637
- Acronym / sponsor ID
- USP 2015-3
- Conditions
- Bronchiectasis
- Keywords
- Respiratory System, Physical Therapy Modalities
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Aug 2015 (actual)
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 28 Jul 2015 (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.
Bronchiectasis is characterized pathologically by the abnormal and permanent dilation of bronchi caused mainly by the perpetuation of inflammation and impaired clearance of secretions. Physical therapy is essential in the treatment of these patients, using its various techniques and devices. The aim of this study is to evaluate the impedance of the respiratory system, by impulse oscillometry, after breathing exercises with chest compression or flutter in patients with bronchiectasis, considering that there are no results in the literature on the effect of these techniques in the small airways of these patients.
Detailed description
Bronchiectasis patients and healthy subjects will be evaluated before and after a 30 minutes session of control, breathing exercises with flutter valve, that is a device that produces oscillation and positive pressure during the expiratory phase, or chest compression, that is a manual manoeuvre in the right and left sides of the lower chest, all of them in a sitting position. The main outcome will be obtained by impulse oscillometry, that is a method to access large and small airways, to evaluate the resistance (R), reactance (X), reactance area (AX) and resonant frequency (Fres) of respiratory system for the whole breath and for inspiratory and expiratory phase. Additionally, will be analysed the dyspnea using the Medical Research Council scale; acceptability and tolerability scale; pulse oxymetry; difficulty of expectoration score; and volume, adhesivity and purulence of sputum.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Flutter Intervention | Active comparator | Device: Flutter, Other: Impulse Oscillometric, Other: Dyspnea scale, Other: Acceptability and tolerance, Device: Pulse oximetry, Other: Difficulty sputumAfter initial evaluation, the subjects will perform breathing exercises with quiet inspiration and prolonged expiration on the device for thirty minutes, with breaks of one minute every four minutes. Immediately after the exercise will be performed new assessment against Impulse Oscillometry. Then patients will be kept for 30 minutes at rest and at the end will be applied the acceptability and tolerance scale and a third evaluation with Impulse Oscillometry. The secretions expectorated during the protocol will be evaluated for weight, adhesiveness and purulence. |
| Chest Compression Intervention | Active comparator | Other: Chest Compression, Other: Impulse Oscillometric, Other: Dyspnea scale, Other: Acceptability and tolerance, Device: Pulse oximetry, Other: Difficulty sputumAfter initial evaluation, the subjects will be instructed to perform deep breaths between three quiet inspiration brought, and expiration will be accompanied by bilateral compression with the therapist's hands on the lower ribs during thirty minutes with one minute intervals of rest every four minutes. Immediately after the exercise will be performed new assessment against Impulse Oscillometry. Then patients will be kept for 30 minutes at rest and at the end will be applied the acceptability and tolerance scale and a third evaluation with Impulse Oscillometry. The secretions expectorated during the protocol will be evaluated for weight, adhesiveness and purulence. |
| Crontrol Intervention | Active comparator | Other: Control, Other: Impulse Oscillometric, Other: Dyspnea scale, Other: Acceptability and tolerance, Device: Pulse oximetry, Other: Difficulty sputumAfter initial evaluation, patients will be remain seated quiet breathing without any guidance for thirty minutes. Immediately after this time will be held reassessment with Impulse Oscillometry. Then patients will be kept for 30 minutes at rest and at the end will be applied to acceptance and tolerance scale and a third evaluation with Impulse Oscillometry. The secretions expectorated during the protocol will be evaluated for wight, adhesiveness and purulence. |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- aged between 30 and 80 years
- diagnosed with bronchiectasis not resulting from cystic fibrosis, defined by history and full clinical examination and confirmed by computed tomography.
Key exclusion criteria (8 listed)
- Chest pain
- acute hemoptysis
- recent history rib fracture and pneumothorax
- respiratory infection in the last 4 weeks prior to study
- cystic fibrosis
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 |
|---|---|---|
| FlutterFlutter is a small device, simple, like a plastic pipe with a mouthpiece at one end and a perforated cover on the other, containing a steel ball resting in a plastic cone inside. When the patient exhales through the flutter expiratory flow causes movement of the ball, creating an oscillatory positive pressure. | Device | Flutter Intervention |
| Chest CompressionManual chest compression is based on the application of forces resulting from the action of respiratory muscles or physiotherapist manual action in order to increase the alveolar pressure creating a pressure gradient to promote change in pulmonary flow and volume.It consists of vigorous compression of the chest at the beginning of expiration or during expiration. | Other | Chest Compression Intervention |
| Control | Other | Crontrol Intervention |
| Impulse OscillometricFor this measure will be used IOS Jaeger (Jaeger, Wurzburg, Germany). to minimize the effect of the bad positioning of the tongue will use a mouth "free-flow", which contains a depressant for keeping the tongue in the mouth soil, stabilizing it and reducing oral resistance. Volunteers will support hands firmly on the cheeks to reduce the effect of oscillation thereof. The measures will be carried out with the volunteer sitting, using nasal, relaxed and your head in neutral clip, breathing normally through the mouthpiece to his lips tightly sealed to prevent air leaks. | Other | Chest Compression Intervention, Crontrol Intervention, Flutter Intervention |
| Dyspnea scaleDyspnea will be evaluated across the range Medical Research Council (MRC) for use in patients with chronic obstructive pulmonary disease in Brazil. | Other | Chest Compression Intervention, Crontrol Intervention, Flutter Intervention |
| Acceptability and tolerancepatients will complete scales 1-7, 1: extremely and 7: none) on usefulness, ease to understand the instructions, easy to perform the exercises, degree of fatigue and discomfort | Other | Chest Compression Intervention, Crontrol Intervention, Flutter Intervention |
| Pulse oximetryDuring therapy the patient will remain monitored with digital oximeter and the information will be recorded before and after the procedures | Device | Chest Compression Intervention, Crontrol Intervention, Flutter Intervention |
| Difficulty sputumPatients inform the ease or difficulty sputum according to a scale of 1 to 5, where 1 = no difficulty and 5 = extremely difficult. | Other | Chest Compression Intervention, Crontrol Intervention, Flutter Intervention |
Primary outcome
Respiratory System Impedance
Time frame: In the primary evaluation, and after seven and fourteen days.
Will be evaluated the resistance (R), reactance (X), reactance area (AX) and resonance frequency (Fres) before, immediately after the intervention and after 30 minutes of rest in order of identifying changes in the components of resistance of airways of individuals.
Difficulty sputum
Time frame: In the primary evaluation, and after seven and fourteen days.
Patients inform the ease or difficulty in expectoration in accordance with a scale of 1 to 5, where 1 = no difficulty and 5 = extremely difficult. (Burioka, 1998). The scale will be applied at baseline and always after the intervention to assess whether there is difference in the difficulty of sputum between sessions.
Secretions weight
Time frame: In the primary evaluation, and after seven and fourteen days.
The secretions are collected in the universal and heavy collectors on a precision balance.They will be evaluated in the total weight measurements and a dry weight and wet mucus. The weight of mucus of each interventions are compared to determine a technique with improved efficiency for removal of secretions.
4 secondary outcomes
Pulse oximetry
Time frame: In the primary evaluation, and after seven and fourteen days.
Acceptability and tolerance
Time frame: In the primary evaluation, and after seven and fourteen days.
Dyspnea scale:
Time frame: In the primary evaluation, and after seven and fourteen days.
Adhesiveness of expectorated secretion:
Time frame: In the primary evaluation, and after seven and fourteen days.
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 23 Feb 2017.
- Background: PubMed 21641196Tambascio J, de Souza LT, Lisboa RM, Passarelli Rde C, de Souza HC, Gastaldi AC. The influence of Flutter(R)VRP1 components on mucus transport of patients with bronchiectasis. Respir Med. 2011 Sep;105(9):1316-21. doi: 10.1016/j.rmed.2011.04.017.
- Background: PubMed 14680096Oostveen E, MacLeod D, Lorino H, Farre R, Hantos Z, Desager K, Marchal F; ERS Task Force on Respiratory Impedance Measurements. The forced oscillation technique in clinical practice: methodology, recommendations and future developments. Eur Respir J. 2003 Dec;22(6):1026-41. doi: 10.1183/09031936.03.00089403.
- Background: PubMed 19648517Murray MP, Pentland JL, Turnbull K, MacQuarrie S, Hill AT. Sputum colour: a useful clinical tool in non-cystic fibrosis bronchiectasis. Eur Respir J. 2009 Aug;34(2):361-4. doi: 10.1183/09031936.00163208.
- Background: PubMed 17132121McCarren B, Alison JA, Herbert RD. Manual vibration increases expiratory flow rate via increased intrapleural pressure in healthy adults: an experimental study. Aust J Physiother. 2006;52(4):267-71. doi: 10.1016/s0004-9514(06)70006-x.
- Results publication: PubMed 17416150Eaton T, Young P, Zeng I, Kolbe J. A randomized evaluation of the acute efficacy, acceptability and tolerability of flutter and active cycle of breathing with and without postural drainage in non-cystic fibrosis bronchiectasis. Chron Respir Dis. 2007;4(1):23-30. doi: 10.1177/1479972306074481.
- Derived from this study: PubMed 31138732de Souza Simoni LH, Dos Santos DO, de Souza HCD, Baddini-Martinez JA, Santos MK, Gastaldi AC. Acute Effects of Oscillatory PEP and Thoracic Compression on Secretion Removal and Impedance of the Respiratory System in Non-Cystic Fibrosis Bronchiectasis. Respir Care. 2019 Jul;64(7):818-827. doi: 10.4187/respcare.06025. Epub 2019 May 28.
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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.
Ada C Gastaldi, PhD principal investigator
Ribeirão Preto Medicine School - University of São Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Flutter, Chest Compression and Impulse Oscillometric in people with Bronchiectasis, run by University of Sao Paulo 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 8 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 23 Feb 2017. 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?
Respiratory System Impedance (time frame: In the primary evaluation, and after seven and fourteen days.). The study lists 3 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 NCT02509637, which also lists 6 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 23 Feb 2017.