Registrations and Clinical Trials

RegistRations

TGA Registration #328314

Registered by the Australian Governments Therapeutic Goods Association (TGA) as a Class 1 Medical Device for providing positive end-expiratory pressure therapy for patients with mucus producing respiratory conditions including; 
Atelectasis, Bronchitis, Bronchiectasis, Cystic Fibrosis, Chronic Obstructive Pulmonary Diseases (COPDs), such as asthma, and other conditions producing retained secretions. 

FDA Registration #12580180464

The U.S. Food and Drug Administration (FDA) requires businesses that are involved in the production and distribution of medical devices intended for use in the United States to be registered with FDA.

CE Registration #20190320488

The CE marking is the manufacturer’s declaration that the product meets the the European Union’s (EU) standards for health, safety, and environmental protection.

Clinical Trials

Turboforte™ Lung Physio and other similar flutter devices have participated in many clinical trials, and have also undertaken rigorous testing in many hospitals and universities world-wide. Below is a representation of a few of the completed studies.    

Study

Oscillatory Positive Expiratory Pressure in Chronic Obstructive Pulmonary Disease

Finding

“In COPD patients with chronic sputum production, PEQ and SGRQ scores, FVC and 6MWD improved post-oPEP. FEV1 and PEQ-ease-bringing-up-sputum improvements were related to improved ventilation providing mechanistic evidence to support oPEP use in COPD.”

Abstract

Evidence-based guidance for the use of airway clearance techniques (ACT) in chronic obstructive pulmonary disease (COPD) is lacking in-part because well-established measurements of pulmonary function such as the forced expiratory volume in 1s (FEV1) are relatively insensitive to ACT. The objective of this crossover study was to evaluate daily use of an oscillatory positive expiratory pressure (oPEP) device for 21-28 days in COPD patients who were self-identified as sputum-producers or non-sputum-producers. COPD volunteers provided written informed consent to daily oPEP use in a randomized crossover fashion. Participants completed baseline, crossover and study-end pulmonary function tests, St. George’s Respiratory Questionnaire (SGRQ), Patient Evaluation Questionnaire (PEQ), Six-Minute Walk Test and (3)He magnetic resonance imaging (MRI) for the measurement of ventilation abnormalities using the ventilation defect percent (VDP). Fourteen COPD patients, self-identified as sputum-producers and 13 COPD-non-sputum-producers completed the study. Post-oPEP, the PEQ-ease-bringing-up-sputum was improved for sputum-producers (p = 0.005) and non-sputum-producers (p = 0.04), the magnitude of which was greater for sputum-producers (p = 0.03). There were significant post-oPEP improvements for sputum-producers only for FVC (p = 0.01), 6MWD (p = 0.04), SGRQ total score (p = 0.01) as well as PEQ-patient-global-assessment (p = 0.02). Clinically relevant post-oPEP improvements for PEQ-ease-bringing-up-sputum/PEQ-patient-global-assessment/SGRQ/VDP were observed in 8/7/9/6 of 14 sputum-producers and 2/0/3/3 of 13 non-sputum-producers. The post-oPEP change in (3)He MRI VDP was related to the change in PEQ-ease-bringing-up-sputum (r = 0.65, p = 0.0004) and FEV1 (r = -0.50, p = 0.009). In COPD patients with chronic sputum production, PEQ and SGRQ scores, FVC and 6MWD improved post-oPEP. FEV1 and PEQ-ease-bringing-up-sputum improvements were related to improved ventilation providing mechanistic evidence to support oPEP use in COPD. Clinical Trials # NCT02282189 and NCT02282202.

https://pubmed.ncbi.nlm.nih.gov/26430763/

Cited

Svenningsen S, Paulin GA, Sheikh K, et al. Oscillatory Positive Expiratory Pressure in Chronic Obstructive Pulmonary Disease. COPD. 2016;13(1):66-74. doi:10.3109/15412555.2015.1043523

Study

Noncystic Fibrosis Bronchiectasis: Regional Abnormalities and Response to Airway Clearance Therapy Using Pulmonary Functional Magnetic Resonance Imaging

Finding

There was CT and MRI evidence of structure-function abnormalities in patients with bronchiectasis; in approximately half, there was evidence of ventilation improvements after airway clearance therapy.”

Abstract

Rationale and objectives: Evidence-based treatment and management for patients with bronchiectasis remain challenging. There is a need for regional disease measurements as focal distribution of disease is common. Our objective was to evaluate the ability of magnetic resonance imaging (MRI) to detect regional ventilation impairment and response to airway clearance therapy (ACT) in patients with noncystic fibrosis (CF) bronchiectasis, providing a new way to objectively and regionally evaluate response to therapy.

Materials and methods: Fifteen participants with non-CF bronchiectasis and 15 age-matched healthy volunteers provided written informed consent to an ethics board-approved Health Insurance Portability and Accountability Act-compliant protocol and underwent spirometry, plethysmography, computed tomography (CT), and hyperpolarized 3He MRI. Bronchiectasis patients also completed a Six-Minute Walk Test, the St. George’s Respiratory questionnaire, and Patient Evaluation Questionnaire (PEQ), and returned for a follow-up visit after 3 weeks of daily oscillatory positive expiratory pressure use. CT evidence of bronchiectasis was qualitatively reported by lobe, and MRI ventilation defect percent (VDP) was measured for the entire lung and individual lobes.

Results: CT evidence of bronchiectasis and abnormal VDP (14 ± 7%) was observed for all bronchiectasis patients and no healthy volunteers. There was CT evidence of bronchiectasis in all lobes for 3 patients and in 3 ± 1 lobes (range = 1-4) for 12 patients. VDP in lobes with CT evidence of bronchiectasis (19 ± 12%) was significantly higher than in lobes without CT evidence of bronchiectasis (8 ± 5%, P = .001). For patients, VDP in lung lobes with (P < .0001) and without CT evidence of bronchiectasis (P = .006) was higher than in healthy volunteers (3 ± 1%). For all patients, mean PEQ-ease-bringing-up-sputum (P = .048) and PEQ-patient-global-assessment (P = .01) were significantly improved post-oscillatory positive expiratory pressure. An improvement in regional VDP greater than the minimum clinical important difference was observed for 8 of the 14 patients evaluated.

Conclusions: There was CT and MRI evidence of structure-function abnormalities in patients with bronchiectasis; in approximately half, there was evidence of ventilation improvements after airway clearance therapy.

https://pubmed.ncbi.nlm.nih.gov/27717759/

Cited

Svenningsen S, Guo F, McCormack DG, Parraga G. Noncystic Fibrosis Bronchiectasis: Regional Abnormalities and Response to Airway Clearance Therapy Using Pulmonary Functional Magnetic Resonance Imaging. Acad Radiol. 2017;24(1):4-12. doi:10.1016/j.acra.2016.08.021

Study

Oscillating Positive Expiratory Pressure on Respiratory Resistance in Chronic Obstructive Pulmonary Disease With a Small Amount of Secretion: A Randomized Clinical Trial

Finding

The use of flutter can decrease the respiratory system resistance and reactance and expiratory flow limitation in stable COPD patients with small amounts of secretions.”

Study Details

Chronic obstructive pulmonary disease (COPD) is characterised by airflow limitation that is not fully reversible, and is usually progressive and associated with an abnormal inflammatory response of the lungs to noxious particles or gases, most commonly cigarette smoking. The disease affects not only the large central airways but also the small, more peripheral airways deeper into the lung, defined as less than 2 mm in diameter.

Besides medical treatment, physiotherapy plays a major role in treatment and various methods have been suggested to remove airway of secretions. The flutter is a simple and small device shaped like a pipe that creates a positive expiratory pressure (PEP) and high frequency oscillation when the expired air passes through it. These vibrations are thought to mobilise airway secretions facilitating their clearance and improving breathing.

Standard blowing tests, like spirometry, where patients blow forcedly into a machine, have previously been used to investigate the efficacy of flutter devices. However, spirometry assesses the damage of larger airways but not small airways, also known as the “silent zone” which, crucially, are specifically damaged in COPD.

In this study the investigators hypothesise that because the flutter helps clear the airways from the excessive thick mucus produced by COPD patients, these patients may find it easier to breathe and have lower resistance to moving air in and out of their lungs.

The main objective of this study is to compare the effect of a flutter or a sham device on small airways damage using impulse oscillometry (IOS), a non-invasive method that, contrary to other common blowing tests, measures small airway resistance during normal breathing.

In addition, because COPD is characterised by inflammation, the investigators would also like to measure a gas the patients blow out, nitric oxide (NO) the levels of which reflect airway inflammation. This will give to investigators an insight into the relationship between airway inflammation and small airway function.

https://clinicaltrials.gov/ct2/show/results/NCT01832961

Cited

Gastaldi AC, Paredi P, Talwar A, Meah S, Barnes PJ, Usmani OS. Oscillating Positive Expiratory Pressure on Respiratory Resistance in Chronic Obstructive Pulmonary Disease With a Small Amount of Secretion: A Randomized Clinical Trial. Medicine (Baltimore). 2015 Oct;94(42):e1845. doi: 10.1097/MD.0000000000001845.

Study

OPEP in lower respiratory tract infections

Finding

In conclusion, OPEP exhibited a greater effectiveness in draining sputum, improving oxygenation and reducing inflammatory status in patients with lower respiratory tract infections..”

Abstract

Oscillatory positive expiratory pressure (OPEP) devices have been utilized as an adjunct therapy to conventional chest physiotherapy (CPT) to promote the clearance of respiratory secretions in individuals with impaired ability to cough, particularly in chronic diseases. However, few studies have focused on the effectiveness of OPEP in lower respiratory tract infection. In the present study, all patients with lower respiratory tract infections hospitalized in the Department of Pulmonary and Critical Care Medicine, Ruijin Hospital (Shanghai, China) between February 2016 and July 2017 were analyzed. Daily sputum quantity and purulence were recorded on the first 7 days of physiotherapy. Oxygenation index, partial pressure carbon dioxide, white blood cell count, neutrophil percentage, C reactive protein (CRP) and procalcitonin (PCT) levels before and after CPT were compared between patients who received OPEP and patients who received mechanical percussion (MP). Sputum was collected prior to and following CPT. A total of 17 patients received OPEP, while 10 received MP. The OPEP group exhibited improved postural drainage compared with the MP group after 7 days of physiotherapy. After 7 days of CPT, patients who received OPEP also exhibited a significantly improved oxygenation index, while the oxygenation index in the MP group did not improve. The improvement of partial pressure carbon dioxide was not significantly different between groups. The OPEP group also exhibited a greater decrease in white blood cell count, neutrophil percentage and CRP levels, compared with the MP group. However, the decrease in PCT level was similar in the OPEP and MP groups. Sputum culture results revealed that the rate of negative conversion was very low in both groups. There was no difference between the two groups in terms of hospitalization outcomes. In conclusion, OPEP exhibited a greater effectiveness in draining sputum, improving oxygenation and reducing inflammatory status in patients with lower respiratory tract infections compared with MP; however, it did not promote the elimination of microbes.

https://pubmed.ncbi.nlm.nih.gov/30214547

Cited

Ni Y, Ding L, Yu Y, Dai R, Chen H, Shi G. Oscillatory positive expiratory pressure treatment in lower respiratory tract infection. Exp Ther Med. 2018;16(4):3241-3248. doi:10.3892/etm.2018.6552

Study

A Functional Respiratory Imaging Approach to the Effect of an Oscillating Positive Expiratory Pressure Device in Chronic Obstructive Pulmonary Disease

Finding

 The utilization of the OPEP device led to a significant increase of 2.88% in specific airway volume after two weeks “

Abstract

Purpose: Chronic obstructive pulmonary disease (COPD) patients are prone to suffer from chronic bronchitis, which ultimately affects their quality of life and overall prognosis. Oscillating positive expiratory pressure (oPEP) devices are designed to aid in the mucus clearance by generating positive pressure pulses in the airways. The main aim of this study was to analyze the impact of a specific oPEP device – Aerobika® – on top of standard of care medication in COPD patients’ lung dynamics and drug deposition.

Patients and methods: In this single-arm pilot study, patients were assessed using standard spirometry tests and functional respiratory imaging (FRI) before and after a period of 15±3 days of using the oPEP device twice daily (before their standard medication).

Results: The utilization of the oPEP device led to a significant increase of 2.88% in specific airway volume after two weeks (1.44 (SE: 0.18) vs 1.48 (SE: 0.19); 95% CI = [0.03%,5.81%]; p=0.048). Moreover, the internal airflow distribution (IAD) was affected by the treatment: patients’ changes ranged from -6.74% to 4.51%. Furthermore, IAD changes at the lower lobes were also directly correlated with variations in forced expiratory volume in one second and peak expiratory flow; conversely, IAD changes at the upper lobes were inversely correlated with these clinical parameters. Interestingly, this change in IAD was significantly correlated with changes in lobar drug deposition (r 2=0.30, p<0.001).

Conclusion: Our results support that the Aerobika device utilization leads to an improved airflow, which in turn causes a shift in IAD and impacts the drug deposition patterns of the concomitant medication in patients with COPD.

https://pubmed.ncbi.nlm.nih.gov/32581531

Cited

Leemans G, Belmans D, Van Holsbeke C, et al. A Functional Respiratory Imaging Approach to the Effect of an Oscillating Positive Expiratory Pressure Device in Chronic Obstructive Pulmonary Disease. Int J Chron Obstruct Pulmon Dis. 2020;15:1261-1268. Published 2020 Jun 4. doi:10.2147/COPD.S242191
 

Study

Effects of an Airway Clearance Device on Inflammation, Bacteriology, and Mucus Transport in Bronchiectasis

Finding

The use of a flutter valve for 30 min/d for at least 4 weeks is enough to change physical properties and improve mucus transport by coughing and can contribute to the reduction of the total number of inflammatory cells of the respiratory secretions of subjects with bronchiectasis. (ClinicalTrials.gov registration NCT01209546.)”

Abstract

Background: Bronchiectasis is characterized by abnormal and permanent dilation of the bronchi, caused by the perpetuation of inflammation and impairment of mucociliary clearance. Physiotherapy techniques can help to decrease the retention of respiratory secretions. The flutter valve combines high-frequency oscillation and positive expiratory pressure to facilitate the removal of secretions. We evaluated the effects of the flutter valve on sputum inflammation, microbiology, and transport of respiratory secretions in patients with bronchiectasis.

Methods: Seventeen participants underwent sessions with flutter or control (flutter-sham), for 30 min/d, in a randomized crossover study, with 4 weeks with one of the therapies, a 2-week wash-out period, and then another 4 weeks with the other modality. Secretion samples were collected every week throughout the protocol and were assessed for the mucociliary transport, displacement in a simulated cough machine, contact angle, and cell cytology with percentage of neutrophil count, eosinophils, and macrophages, and the microbiology was assessed by the number of colony-forming units.

Results: Treatment with flutter resulted in greater displacement in a simulated cough machine and smaller contact angle, comparing the results between the first week (9.94 ± 3.12 cm and 26.5 ± 3.21°, respectively) and fourth week of treatment (13.96 ± 5.76 cm and 22.76 ± 3.64°, respectively) and was associated with a decrease in the total number of inflammatory cells.

Conclusions: The use of a flutter valve for 30 min/d for at least 4 weeks is enough to change physical properties and improve mucus transport by coughing and can contribute to the reduction of the total number of inflammatory cells of the respiratory secretions of subjects with bronchiectasis. (ClinicalTrials.gov registration NCT01209546.).

https://pubmed.ncbi.nlm.nih.gov/28733313

Cited

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;62(8):1067-1074. doi:10.4187/respcare.05214
 

Study

Positive Expiratory Pressure Therapy With And Without Oscillation And Hospital Length Of Stay For Acute Exacerbation Of Chronic Obstructive Pulmonary Disease

Finding

“ Adjunctive therapy with a PEP device versus standard care may reduce hospital LOS in patients admitted for AECOPD.”

Abstract

Introduction: Pharmacologic management of acute exacerbation of chronic obstructive pulmonary disease (AECOPD) is well-established. Our aim in the current study is to determine if therapy with a positive expiratory pressure (PEP) device with or without an oscillatory mechanism (OM) in addition to standard care results in a reduction in hospital length of stay (LOS) among patients hospitalized for AECOPD.

Methods: Two studies were performed and are reported here. Study 1: Patients admitted with AECOPD and sputum production were enrolled in a prospective trial comparing PEP therapy versus Oscillatory PEP (OPEP) therapy. Study 2: A retrospective historical cohort, matched in a 2 to 1 manner by age, gender, and season of admission, was compared with the prospectively collected data to determine the effect of PEP ± OM versus standard care on hospital LOS.

Results: In the prospective trial (Study 1; 91 subjects), median hospital LOS was 3.2 (95% CI 3.0-4.3) days in the OPEP group and 4.8 (95% CI 3.9-6.1) days in the PEP group (p=0.16). In fully adjusted models comparing the prospective trial data with the retrospective cohort (Study 2; 182 subjects), cases had a median hospital LOS of 4.2 days (95% CI 3.8-5.1) versus 5.2 days (95% CI 4.4-6.0) in controls, consistent with a shorter hospital LOS with adjunctive PEP±OM therapy versus standard care (p=0.04).

Conclusion: Adjunctive therapy with a PEP device versus standard care may reduce hospital LOS in patients admitted for AECOPD. Although the addition of an OM component to PEP therapy suggests a further reduction in hospital LOS, comprehensive multicenter randomized controlled trials are needed to confirm these findings.

https://pubmed.ncbi.nlm.nih.gov/31819393

Cited

Milan S, Bondalapati P, Megally M, et al. Positive Expiratory Pressure Therapy With And Without Oscillation And Hospital Length Of Stay For Acute Exacerbation Of Chronic Obstructive Pulmonary Disease. Int J Chron Obstruct Pulmon Dis. 2019;14:2553-2561. Published 2019 Nov 20. doi:10.2147/COPD.S213546
 
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