Trial record 1 of 1 for:    NCT01209546
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Study of the Effect of FLUTTER® VRP1 (PEP and Oscillating High Frequency). (FLUTTER®VRP1)

This study has been terminated.
(The protocol finished.)
Sponsor:
Information provided by (Responsible Party):
Ada Clarice Gastaldi, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01209546
First received: July 12, 2010
Last updated: June 26, 2012
Last verified: September 2010
  Purpose

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


Condition Intervention Phase
Bronchiectasis
Other: control group
Other: Flutter group
Other: PEP group
Other: Group Sham
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Study of the Effect of FLUTTER VRP1 in Patients With Bronchiectasis.

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • The Effect of FLUTTER VRP1 on respiratory mucus transport [ Time Frame: five years ] [ Designated as safety issue: No ]
    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).


Enrollment: 30
Study Start Date: July 2007
Study Completion Date: December 2010
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Flutter group
In Flutter group the exercise used the Flutter ®VRP1 (VarioRaw SA, Switzerland).
Other: 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).
Other Name: Futter VRP1 device without modification
Active Comparator: PEP group
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.
Other: 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).
Other Name: Flutter VRP1 without the ball inside
Placebo Comparator: control group
In placebo patients were assessed as pulmonary function, respiratory muscle strength and transport properties of respiratory secretions
Other: control group
In placebo patients were assessed and were not subjected to any respiratory physical therapy technique.
Other Name: group without therapy
Sham Comparator: Group Sham
Exercise with Flutter®VRP1 without the ball inside
Other: 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)
Other Name: Group Sham

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

Ages Eligible for Study:   20 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01209546

Locations
Brazil
Faculty of Medicine of Ribeirão Preto, University of Sao Paulo
Ribeirão Preto, São Paulo, Brazil, 14049-900
Sponsors and Collaborators
University of Sao Paulo
Investigators
Study Chair: Ada C. Gastaldi, doctor University of Sao Paulo
  More Information

Additional Information:
Publications:
Responsible Party: Ada Clarice Gastaldi, Professor Ada Clarice Gastaldi, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01209546     History of Changes
Other Study ID Numbers: USP 2010-2
Study First Received: July 12, 2010
Last Updated: June 26, 2012
Health Authority: Brazil: National Health Surveillance Agency

Keywords provided by University of Sao Paulo:
Bronchiectasis
Pulmonary function
Respiratory muscle strength
Respiratory secretions

Additional relevant MeSH terms:
Bronchiectasis
Bronchial Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 28, 2014