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

NCT01209546 | Terminated Phase 1 DMC

• 1 other identifier: USP 2010-2
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Bronchiectasis

Keywords

Bronchiectasis; Pulmonary function; Respiratory muscle strength; Respiratory secretions

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

Flutter group

ACTIVE COMPARATOR

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

Other: Flutter group

PEP group

ACTIVE COMPARATOR

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

control group

PLACEBO COMPARATOR

In placebo patients were assessed as pulmonary function, respiratory muscle strength and transport properties of respiratory secretions

Other: control group

Group Sham

SHAM COMPARATOR

Exercise with Flutter®VRP1 without the ball inside

Other: Group Sham

Interventions

control group OTHER

In placebo patients were assessed and were not subjected to any respiratory physical therapy technique.

Also known as: group without therapy

control group

Flutter group OTHER

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).

Also known as: Futter VRP1 device without modification

Flutter group

PEP group OTHER

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).

Also known as: Flutter VRP1 without the ball inside

PEP group

Group Sham OTHER

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)

Group Sham

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Non Cystic Fibrosis Bronchiectasis
• Amount of secretion sufficient for analysis
• Capable of fulfilling the experimental protocol

You may not qualify if:

• Acute pulmonary disease
• Presence of any respiratory infection in the last four weeks

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

Faculty of Medicine of Ribeirão Preto, University of Sao Paulo

Ribeirão Preto, São Paulo, 14049-900, Brazil

Location

Related Publications (4)

• 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.

  PMID: 9674466 RESULT

• 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.

  PMID: 1280928 RESULT

• 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.

  PMID: 11978924 RESULT

• 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.

  PMID: 28733314 DERIVED

Related Links

• University of São Paulo link

MeSH Terms

Conditions

Bronchiectasis

Interventions

Control Groups; Population Groups; Therapeutics

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods; Demography; Population Characteristics

Study Officials

• Ada C. Gastaldi, doctor

  University of Sao Paulo

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Ada Clarice Gastaldi

Study Record Dates

• First Submitted: July 12, 2010
• First Posted: September 27, 2010
• Study Start: July 1, 2007
• Primary Completion: January 1, 2008
• Study Completion: December 1, 2010
• Last Updated: June 28, 2012

Record last verified: 2010-09

Locations

BR (1)