BronchiectasisPhase 1FLUTTER®VRP1NCT01209546
Study of the Effect of FLUTTER® VRP1 (PEP and Oscillating High Frequency).
A Phase 1 study testing Flutter group and PEP group in people with Bronchiectasis, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
The research sought to assess the effects of Flutter ® VRP1 in patients with bronchiectasis. Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Bronchiectasis
- What is being tested?
- Flutter group and PEP group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- Jul 2007to Dec 2010
- Phase
- Phase 1
- 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 20 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Non Cystic Fibrosis Bronchiectasis
- Amount of secretion sufficient for analysis
- Capable of fulfilling the experimental protocol
Who cannot join
- Acute pulmonary disease
- Presence of any respiratory infection in the last four weeks
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Faculty of Medicine of Ribeirão Preto, University of Sao Paulo
Ribeirão Preto, São Paulo, 14049-900
About this study
Official title: Study of the Effect of FLUTTER VRP1 in Patients With Bronchiectasis.
The research sought to assess the effects of Flutter ® VRP1 in patients with bronchiectasis.
Read the detailed description
Bronchiectasis is an airway disease with many etiologies characterized pathologically by the abnormal permanent dilatation of bronchi, caused mainly by the perpetuation of inflammatory processes induced by frequent episodes of bacterial infections, with consequent change in the ciliated epithelial lining and compromising the effectiveness of mucociliary clearance that can favor the hypersecretive state found in these patients.
In addition to drug therapy or surgical treatment, patients with bronchiectasis also have physiotherapy, which is an important part in treatment. The patients present impaired mucus transport, and can enjoy the benefits provided by respiratory therapy, which features intended to increase the removal of airway secretions and thus reduce the obstruction to improve ventilation and oxygenation.
One of the instruments commonly used in respiratory therapy is the Flutter ® VRP1 (VarioRaw SA, Switzerland), which is a simple equipment, small, similar to a pipe that combines two techniques: positive expiratory pressure (PEP) and high-frequency oscillations.
Some previous studies have shown beneficial effects after use of this device in patients with bronchiectasis. However, it is unclear whether the mechanism of action is related to the combination of PEP and the techniques of high frequency oscillation, or just one of those components.
- Conditions
- Bronchiectasis
- Being tested
- control group, Flutter group, PEP group, Group Sham
- Keywords
- Bronchiectasis, Pulmonary function, Respiratory muscle strength, Respiratory secretions
- Medical subject headings
- Bronchiectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
control groupOther
Also called group without therapy
In placebo patients were assessed and were not subjected to any respiratory physical therapy technique.
Flutter groupOther
Also called Futter VRP1 device without modification
Patients have done exercise sessions with Flutter ®VRP1 for 30 minutes daily in a randomized, crossover, with four weeks of treatment with a therapy, a week of wash-out followed by four more weeks with the other modality (PEP).
PEP groupOther
Also called Flutter VRP1 without the ball inside
Patients have done exercise sessions with Flutter® VRP1 without the steel ball inside, with the closure of so many holes as necessary to produce a positive expiratory pressure equivalent to pressure achieved by patients during the performance with the ball in the Flutter®VRP1 for 30 minutes daily in a randomized, crossover, with four weeks of treatment with a therapy, a week of wash-out followed by four more weeks with the other modality (Flutter®VRP1).
Group ShamOther
Patients have done exercise sessions with Flutter ®VRP1 for 30 minutes without the ball inside daily in a randomized, crossover, with four weeks of treatment with a therapy, a week of wash-out followed by four more weeks with the other modality (PEP)
| Study group | Role | What they receive |
|---|---|---|
| Flutter group | Active comparator | In Flutter group the exercise used the Flutter ®VRP1 (VarioRaw SA, Switzerland). Receives: Other: Flutter group |
| PEP group | Active comparator | In PEP group the exercise used the Flutter ®VRP1 (VarioRaw SA, Switzerland) without the steel ball inside, with the closure of so many holes as necessary to produce a positive expiratory pressure equivalent to pressure achieved by patients during the performance with the ball in the Flutter®VRP1. Receives: Other: PEP group |
| control group | Placebo comparator | In placebo patients were assessed as pulmonary function, respiratory muscle strength and transport properties of respiratory secretions Receives: Other: control group |
| Group Sham | Sham comparator | Exercise with Flutter®VRP1 without the ball inside Receives: Other: Group Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Effect of FLUTTER VRP1 on respiratory mucus transport
30 patients with bronchiectasis will receive sessions with the Flutter®VRP1 or PEP for 30 minutes daily in a randomized, crossover study. Weekly secretion samples will be collected and evaluated for mucociliary relative transport velocity(RTV), displacement in a simulated cough machine(SCM) and contact angle measurement(CAM).
Measured: five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2010 (estimated)
- Study startJul 2007
- Primary completionJan 2008
- Study completionDec 2010
Why it stopped: The protocol finished.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 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, doctor, Study chair, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01209546
- Sponsor's protocol ID
- USP 2010-2
- Acronym
- FLUTTER®VRP1
- Status last verified
- Sep 2010
- First submitted
- 12 Jul 2010
- Last updated
- 28 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
App EM, Kieselmann R, Reinhardt D, Lindemann H, Dasgupta B, King M, Brand P. Sputum rheology changes in cystic fibrosis lung disease following two different types of physiotherapy: flutter vs autogenic drainage. Chest. 1998 Jul;114(1):171-7. doi: 10.1378/chest.114.1.171.
PubMed 9674466Fahy JV, Schuster A, Ueki I, Boushey HA, Nadel JA. Mucus hypersecretion in bronchiectasis. The role of neutrophil proteases. Am Rev Respir Dis. 1992 Dec;146(6):1430-3. doi: 10.1164/ajrccm/146.6.1430.
PubMed 1280928Thompson CS, Harrison S, Ashley J, Day K, Smith DL. Randomised crossover study of the Flutter device and the active cycle of breathing technique in non-cystic fibrosis bronchiectasis. Thorax. 2002 May;57(5):446-8. doi: 10.1136/thorax.57.5.446.
PubMed 11978924Tambascio J, de Souza HCD, Martinez R, Baddini-Martinez JA, Barnes PJ, Gastaldi AC. Effects of an Airway Clearance Device on Inflammation, Bacteriology, and Mucus Transport in Bronchiectasis. Respir Care. 2017 Aug;62(8):1067-1074. doi: 10.4187/respcare.05214.
PubMed 28733314
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Effect of FLUTTER VRP1 in Patients With Bronchiectasis.
- ClinicalTrials.gov ID
- NCT01209546
- Acronym / sponsor ID
- FLUTTER®VRP1 / USP 2010-2
- Conditions
- Bronchiectasis
- Keywords
- Bronchiectasis, Pulmonary function, Respiratory muscle strength, Respiratory secretions
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The protocol finished.
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Jul 2007
- Primary completion
- Jan 2008 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 27 Sep 2010 (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.
The research sought to assess the effects of Flutter ® VRP1 in patients with bronchiectasis.
Detailed description
Bronchiectasis is an airway disease with many etiologies characterized pathologically by the abnormal permanent dilatation of bronchi, caused mainly by the perpetuation of inflammatory processes induced by frequent episodes of bacterial infections, with consequent change in the ciliated epithelial lining and compromising the effectiveness of mucociliary clearance that can favor the hypersecretive state found in these patients.
In addition to drug therapy or surgical treatment, patients with bronchiectasis also have physiotherapy, which is an important part in treatment. The patients present impaired mucus transport, and can enjoy the benefits provided by respiratory therapy, which features intended to increase the removal of airway secretions and thus reduce the obstruction to improve ventilation and oxygenation.
One of the instruments commonly used in respiratory therapy is the Flutter ® VRP1 (VarioRaw SA, Switzerland), which is a simple equipment, small, similar to a pipe that combines two techniques: positive expiratory pressure (PEP) and high-frequency oscillations.
Some previous studies have shown beneficial effects after use of this device in patients with bronchiectasis. However, it is unclear whether the mechanism of action is related to the combination of PEP and the techniques of high frequency oscillation, or just one of those components.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Flutter group | Active comparator | Other: Flutter groupIn Flutter group the exercise used the Flutter ®VRP1 (VarioRaw SA, Switzerland). |
| PEP group | Active comparator | Other: PEP groupIn PEP group the exercise used the Flutter ®VRP1 (VarioRaw SA, Switzerland) without the steel ball inside, with the closure of so many holes as necessary to produce a positive expiratory pressure equivalent to pressure achieved by patients during the performance with the ball in the Flutter®VRP1. |
| control group | Placebo comparator | Other: control groupIn placebo patients were assessed as pulmonary function, respiratory muscle strength and transport properties of respiratory secretions |
| Group Sham | Sham comparator | Other: Group ShamExercise with Flutter®VRP1 without the ball inside |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Non Cystic Fibrosis Bronchiectasis
- Amount of secretion sufficient for analysis
- Capable of fulfilling the experimental protocol
Key exclusion criteria (2 listed)
- Acute pulmonary disease
- Presence of any respiratory infection in the last four weeks
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 |
|---|---|---|
| control groupAlso: group without therapyIn placebo patients were assessed and were not subjected to any respiratory physical therapy technique. | Other | control group |
| Flutter groupAlso: Futter VRP1 device without modificationPatients have done exercise sessions with Flutter ®VRP1 for 30 minutes daily in a randomized, crossover, with four weeks of treatment with a therapy, a week of wash-out followed by four more weeks with the other modality (PEP). | Other | Flutter group |
| PEP groupAlso: Flutter VRP1 without the ball insidePatients have done exercise sessions with Flutter® VRP1 without the steel ball inside, with the closure of so many holes as necessary to produce a positive expiratory pressure equivalent to pressure achieved by patients during the performance with the ball in the Flutter®VRP1 for 30 minutes daily in a randomized, crossover, with four weeks of treatment with a therapy, a week of wash-out followed by four more weeks with the other modality (Flutter®VRP1). | Other | PEP group |
| Group ShamPatients have done exercise sessions with Flutter ®VRP1 for 30 minutes without the ball inside daily in a randomized, crossover, with four weeks of treatment with a therapy, a week of wash-out followed by four more weeks with the other modality (PEP) | Other | Group Sham |
Primary outcome
The Effect of FLUTTER VRP1 on respiratory mucus transport
Time frame: five years
30 patients with bronchiectasis will receive sessions with the Flutter®VRP1 or PEP for 30 minutes daily in a randomized, crossover study. Weekly secretion samples will be collected and evaluated for mucociliary relative transport velocity(RTV), displacement in a simulated cough machine(SCM) and contact angle measurement(CAM).
Results and safety
The study was stopped early (reason given: The protocol finished.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2012.
- Results publication: PubMed 9674466App EM, Kieselmann R, Reinhardt D, Lindemann H, Dasgupta B, King M, Brand P. Sputum rheology changes in cystic fibrosis lung disease following two different types of physiotherapy: flutter vs autogenic drainage. Chest. 1998 Jul;114(1):171-7. doi: 10.1378/chest.114.1.171.
- Results publication: PubMed 1280928Fahy JV, Schuster A, Ueki I, Boushey HA, Nadel JA. Mucus hypersecretion in bronchiectasis. The role of neutrophil proteases. Am Rev Respir Dis. 1992 Dec;146(6):1430-3. doi: 10.1164/ajrccm/146.6.1430.
- Results publication: PubMed 11978924Thompson CS, Harrison S, Ashley J, Day K, Smith DL. Randomised crossover study of the Flutter device and the active cycle of breathing technique in non-cystic fibrosis bronchiectasis. Thorax. 2002 May;57(5):446-8. doi: 10.1136/thorax.57.5.446.
- Derived from this study: PubMed 28733314Tambascio J, de Souza HCD, Martinez R, Baddini-Martinez JA, Barnes PJ, Gastaldi AC. Effects of an Airway Clearance Device on Inflammation, Bacteriology, and Mucus Transport in Bronchiectasis. Respir Care. 2017 Aug;62(8):1067-1074. doi: 10.4187/respcare.05214.
- University of São Paulo linkLink provided by the sponsor.
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Bronchiectasis
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, doctor study chair
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Flutter group and PEP group 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 3 inclusion and 2 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: stopped early, as of the sponsor's last update on 28 Jun 2012. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The protocol finished.). Results are not available in the source record.
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?
The Effect of FLUTTER VRP1 on respiratory mucus transport (time frame: five 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 NCT01209546, which also lists 4 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 28 Jun 2012.