Clinical trial NCT01209546: Study of the Effect of FLUTTER® VRP1 (PEP and Oscillating High Frequency).
Official title: Study of the Effect of FLUTTER VRP1 in Patients With Bronchiectasis.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Bronchiectasis
Keywords: Bronchiectasis
Pulmonary function
Respiratory muscle strength
Respiratory secretions
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2010-09-27
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: The Effect of FLUTTER VRP1 on respiratory mucus transport
timeFrame: five years
Secondary outcomes:
Other outcomes:
Locations:
city: Ribeirão Preto
country: Brazil
facility: Faculty of Medicine of Ribeirão Preto, University of Sao Paulo
state: São Paulo
Study officials:
affiliation: University of Sao Paulo
name: Ada C. Gastaldi, doctor
role: STUDY_CHAIR
References:
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.
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.
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.
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.