Oscillatory Positive Expiratory Pressure in Chronic Obstructive Pulmonary Disease

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.

A Real-World Study of 30-Day Exacerbation Outcomes in Chronic Obstructive Pulmonary Disease (COPD) Patients Managed with Aerobika OPEP

“…Despite the availability of a range of therapy options, exacerbations continue to be a common cause of healthcare resource use among COPD patients [14]. The mechanisms for protection from symptomatic exacerbations are not well understood, but improved sputum clearance, reduced variability in airway smooth muscle tone, and increased dyspnea thresholds are possible explanations [9].…”

“…Aerobika (TMI, London, ON) is a handheld mechanical OPEP device where patients exhale against a manually adjusted variable resistance. Aerobika has been shown to significantly improve forced vital capacity (FVC), 6-min walk distance (6MWD), and St. George's Respiratory Questionnaire (SGRQ) score in COPD patients [14]. However, the effectiveness of an OPEP device, such as Aerobika, in reducing the COPD exacerbations has not been studied in a real-world setting.…”

A Real-World Evidence Study Assessing the Impact of Adding the Aerobika Oscillating Positive Expiratory Pressure Device to Standard of Care Upon Healthcare Resource Utilization and Costs in Post-Operative Patients

“…Another study found that the Aerobika OPEP device resulted in a direct medical cost savings of $553 per patient [20]. These data suggest that the reductions in healthcare resource use and costs associated with the Aerobika OPEP device among postoperative patients in our study may result from the beneficial effects of this device on improving airway structure and function [16,17], thus reducing the risk of developing a PPC that warrants rehospitalization.…”

“…Clinical trial results have demonstrated that use of the Aerobika OPEP device significantly improves dyspnea, quality of life, exercise capacity and ease in bringing up sputum in patients with COPD and bronchiectasis [16]. In another clinical trial, the Aerobika OPEP device was further shown to significantly improve ventilation in patients with COPD [17]. In addition, real-world evidence suggests that the use of the Aerobika OPEP device among COPD patients significantly reduces exacerbations by nearly 30% [18].…”

Crossing the Chasm(s): Demonstrating the Clinical Value of Hyperpolarized Gas MRI

“…Here, the authors illustrate yet another important consideration, which is to introduce the concept of minimally important clinical differences in follow-up measurements (11). Although establishing minimally important clinical differences is beyond the scope of one study, the team instead used previously analyzed results of inter-visit variance to establish a smallest detectable difference (12). This value is remarkably small considering the comparable variability of PFT metrics such as FEV 1 is around 6% (13).…”