Viewing Study NCT01209546



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Study NCT ID: NCT01209546
Status: TERMINATED
Last Update Posted: 2012-06-28
First Post: 2010-07-12

Brief Title: Study of the Effect of FLUTTER VRP1 PEP and Oscillating High Frequency
Sponsor: University of Sao Paulo
Organization: University of Sao Paulo

Study Overview

Official Title: Study of the Effect of FLUTTER VRP1 in Patients With Bronchiectasis
Status: TERMINATED
Status Verified Date: 2010-09
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: The protocol finished
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: FLUTTERVRP1
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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None