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

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Brief Title

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.

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 Phase

Phase 1

Study Type

Interventional

Primary Outcome

The Effect of FLUTTER VRP1 on respiratory mucus transport

Condition

Bronchiectasis

Intervention

control group

Study Arms / Comparison Groups

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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Other

Estimated Enrollment

30

Start Date

July 2007

Completion Date

December 2010

Primary Completion Date

January 2008

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

Gender

All

Ages

20 Years - 85 Years

Accepts Healthy Volunteers

No

Contacts

Ada C. Gastaldi, doctor, ,

Location Countries

Brazil

Location Countries

Brazil

Administrative Informations

NCT ID

NCT01209546

Organization ID

USP 2010-2

Responsible Party

Principal Investigator

Study Sponsor

University of Sao Paulo

Study Sponsor

Ada C. Gastaldi, doctor, Study Chair, University of Sao Paulo

Verification Date

September 2010