Antonello Nicolini1, Valentina Mascardi1, Bruna Grecchi2, Maura Ferrari-Bravo3, Paolo Banfi4, Cornelius Barlascini5. 1. Respiratory Diseases Unit, Hospital of Sestri Levante, Italy. 2. Physical Medicine and Rehabilitation, ASL 4 Chiavarese, Italy. 3. Statistics and Biometrics Unit, ASL 4 Chiavarese, Italy. 4. Don Gnocchi Foundation, IRCSS, Milan, Italy. 5. Hygiene and Health Medicine, ASL4 Chiavarese, Italy.
Abstract
INTRODUCTION: In chronic obstructive pulmonary disease (COPD) patients few modalities of airway clearance have demonstrated effectiveness in reducing hypersecretion and bronchial obstruction. Positive expiratory pressure (PEP) is one of these. OBJECTIVE: Our goal was to compare the effectiveness of 2 devices Temporary PEP (T-PEP) and Oscillatory PEP (O-PEP) which use PEP applied at a low expiratory pressure of 1 cm H2 O which creates oscillations that decrease bronchial obstruction in reducing COPD exacerbations and improving respiratory and health status assessment parameters. Each has different mechanism of action. METHODS: A 26 week randomized controlled study evaluated their efficacy in reducing exacerbations and improving health status assessment tests as well as respiratory function parameters in severe to very severe COPD patients. One hundred-twenty patients were enrolled: 40 patients receivedT-PEP therapy; 40 underwent treatment with O-PEP; 40 constituted the control group. The primary outcome was the reduction of exacerbations after 1, 3 and 6 months; secondary outcomes were improvement of lung function and health status assessment tests [Modified Medical Research Council (MMRC) scale, Breathlessness, Cough, and Sputum Scale (BCSS) scale, and COPD Assessment Test (CAT) score]. RESULTS: Only T-PEP statistically reduced the exacerbations after 1 and 3 months compared to the control group. Both the 2 devices improved dyspnea scale (MMRC), lung function parameters, and health status assessment (CAT) tests compared to the control group. Both interventions were well-tolerated by our patients. CONCLUSIONS: O-PEP and T-PEP are useful for COPD treatment but only T-PEP reduces exacerbations. Adding tools for airway clearance to medical therapy can help the management of COPD.
RCT Entities:
INTRODUCTION: In chronic obstructive pulmonary disease (COPD) patients few modalities of airway clearance have demonstrated effectiveness in reducing hypersecretion and bronchial obstruction. Positive expiratory pressure (PEP) is one of these. OBJECTIVE: Our goal was to compare the effectiveness of 2 devices Temporary PEP (T-PEP) and Oscillatory PEP (O-PEP) which use PEP applied at a low expiratory pressure of 1 cm H2 O which creates oscillations that decrease bronchial obstruction in reducing COPD exacerbations and improving respiratory and health status assessment parameters. Each has different mechanism of action. METHODS: A 26 week randomized controlled study evaluated their efficacy in reducing exacerbations and improving health status assessment tests as well as respiratory function parameters in severe to very severe COPDpatients. One hundred-twenty patients were enrolled: 40 patients received T-PEP therapy; 40 underwent treatment with O-PEP; 40 constituted the control group. The primary outcome was the reduction of exacerbations after 1, 3 and 6 months; secondary outcomes were improvement of lung function and health status assessment tests [Modified Medical Research Council (MMRC) scale, Breathlessness, Cough, and Sputum Scale (BCSS) scale, and COPD Assessment Test (CAT) score]. RESULTS: Only T-PEP statistically reduced the exacerbations after 1 and 3 months compared to the control group. Both the 2 devices improved dyspnea scale (MMRC), lung function parameters, and health status assessment (CAT) tests compared to the control group. Both interventions were well-tolerated by our patients. CONCLUSIONS: O-PEP and T-PEP are useful for COPD treatment but only T-PEP reduces exacerbations. Adding tools for airway clearance to medical therapy can help the management of COPD.
Authors: M D Shen; L R Guo; Y W Li; R T Gao; X Sui; Z Du; L Q Xu; H Y Shi; Y Y Ni; X Zhang; Y Pang; W Zhang; T Z Yu; F Li Journal: Trials Date: 2021-03-23 Impact factor: 2.279