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

Bronchiectasis Clinical Trial

— FLUTTER®VRP1  

Official title:

Study of the Effect of FLUTTER VRP1 in Patients With Bronchiectasis.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01209546
• Other study ID #: USP 2010-2
• Status: Terminated
• Phase: Phase 1
• First received: July 12, 2010
• Last updated: June 26, 2012
• Start date: July 2007
• Est. completion date: December 2010

Study information

• Verified date: September 2010
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial Summary

The research sought to assess the effects of Flutter ® VRP1 in patients with bronchiectasis.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 30
• Est. completion date: December 2010
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bronchiectasis

Intervention

Other:
• control group
In placebo patients were assessed and were not subjected to any respiratory physical therapy technique.
• Flutter group
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 group
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 Sham
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)

Locations

Country	Name	City	State
Brazil	Faculty of Medicine of Ribeirão Preto, University of Sao Paulo	Ribeirão Preto	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	five years	No

External Links

•   University of São Paulo link