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Study of the Effect of FLUTTER® VRP1 (PEP and Oscillating High Frequency). (FLUTTER®VRP1)

Primary Purpose

Bronchiectasis

Status
Terminated
Phase
Phase 1
Locations
Brazil
Study Type
Interventional
Intervention
control group
Flutter group
PEP group
Group Sham
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bronchiectasis focused on measuring Bronchiectasis, Pulmonary function, Respiratory muscle strength, Respiratory secretions

Eligibility Criteria

20 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Non Cystic Fibrosis Bronchiectasis
  • Amount of secretion sufficient for analysis
  • Capable of fulfilling the experimental protocol

Exclusion Criteria:

  • Acute pulmonary disease
  • Presence of any respiratory infection in the last four weeks

Sites / Locations

  • Faculty of Medicine of Ribeirão Preto, University of Sao Paulo

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Sham Comparator

Arm Label

Flutter group

PEP group

control group

Group Sham

Arm Description

In Flutter group the exercise used the Flutter ®VRP1 (VarioRaw SA, Switzerland).

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.

In placebo patients were assessed as pulmonary function, respiratory muscle strength and transport properties of respiratory secretions

Exercise with Flutter®VRP1 without the ball inside

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

First Posted
July 12, 2010
Last Updated
June 26, 2012
Sponsor
University of Sao Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT01209546
Brief Title
Study of the Effect of FLUTTER® VRP1 (PEP and Oscillating High Frequency).
Acronym
FLUTTER®VRP1
Official Title
Study of the Effect of FLUTTER VRP1 in Patients With Bronchiectasis.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2010
Overall Recruitment Status
Terminated
Why Stopped
The protocol finished.
Study Start Date
July 2007 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchiectasis
Keywords
Bronchiectasis, Pulmonary function, Respiratory muscle strength, Respiratory secretions

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Flutter group
Arm Type
Active Comparator
Arm Description
In Flutter group the exercise used the Flutter ®VRP1 (VarioRaw SA, Switzerland).
Arm Title
PEP group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
control group
Arm Type
Placebo Comparator
Arm Description
In placebo patients were assessed as pulmonary function, respiratory muscle strength and transport properties of respiratory secretions
Arm Title
Group Sham
Arm Type
Sham Comparator
Arm Description
Exercise with Flutter®VRP1 without the ball inside
Intervention Type
Other
Intervention Name(s)
control group
Other Intervention Name(s)
group without therapy
Intervention Description
In placebo patients were assessed and were not subjected to any respiratory physical therapy technique.
Intervention Type
Other
Intervention Name(s)
Flutter group
Other Intervention Name(s)
Futter VRP1 device without modification
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
PEP group
Other Intervention Name(s)
Flutter VRP1 without the ball inside
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
Group Sham
Intervention Description
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)
Primary Outcome Measure Information:
Title
The Effect of FLUTTER VRP1 on respiratory mucus transport
Description
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).
Time Frame
five years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Non Cystic Fibrosis Bronchiectasis Amount of secretion sufficient for analysis Capable of fulfilling the experimental protocol Exclusion Criteria: Acute pulmonary disease Presence of any respiratory infection in the last four weeks
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ada C. Gastaldi, doctor
Organizational Affiliation
University of Sao Paulo
Official's Role
Study Chair
Facility Information:
Facility Name
Faculty of Medicine of Ribeirão Preto, University of Sao Paulo
City
Ribeirão Preto
State/Province
São Paulo
ZIP/Postal Code
14049-900
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
9674466
Citation
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.
Results Reference
result
PubMed Identifier
1280928
Citation
Fahy 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 Reference
result
PubMed Identifier
11978924
Citation
Thompson 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.
Results Reference
result
PubMed Identifier
28733314
Citation
Tambascio 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.
Results Reference
derived
Links:
URL
http://www.fmrp.usp.br
Description
University of São Paulo link

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Study of the Effect of FLUTTER® VRP1 (PEP and Oscillating High Frequency).

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