Valentina Mascardi1, Bruna Grecchi2, Cornelius Barlascini3, Paolo Banfi4, Antonello Nicolini1. 1. Respiratory Diseases Unit, Hospital of Sestri Levante, Sestri Levante, Italy. 2. Physical Medicine and Rehabilitation, Chiavari, Italy. 3. Hygiene and Health Medicine Hospital of Sestri Levante, Sestri Levante, Italy. 4. Pulmonary Diseases Unit, Don Gnocchi Foundation IRCCS, Milan, Italy.
Abstract
BACKGROUND:Temporary positive airway pressure (T-PEP) is a tool recently introduced in the treatment of chronic obstructive pulmonary disease (COPD) or bronchiectasis. It demonstrated encouraging results also in severe COPD patients. The aim of this study is verify if adding T-PEP to best bronchodilator therapy both in clinic and home administering could reduce disease exacerbations and improve lung function in patients with severe COPD. METHODS: A total of 142 patients with severe COPD (FEV1 <50%) were enrolled; 120 were randomized in three groups: a group treated with T-PEP at home, a group with T-PEP at hospital and a group with medical therapy only (control group). Number of acute exacerbations COPD (AECOPD) after 1 month and 3 months were the primary outcomes. Secondary outcomes were changes in respiratory function parameters (FVC, FEV1, TLC, RV), arterial blood gases, dyspnea and health status assessment scales (Modified Medical Research Council (MMRC), Breathlessness, Cough and Sputum scale (BCSS) and COPD Assessment Test (CAT). The time of daily use of the T-PEP was registered as well as its acceptance using a Likert scale. RESULTS:Ninety-nine patients completed the study. Both the groups who used T-PEP showed a statistical lower number of AECOPD after 1 month and 3 months (P<0.01). Some respiratory functional parameters improved in the two groups treated with T-PEP (FVC, FEV1, RV) (P<0.02) and dyspnea and health status assessment scales (MMRC, BCSS, CAT) (P<0.04; P<0.01; P<0.009). The time of daily using was similar in the two T-PEP groups. Patients treated at home showed a greater acceptance than those treated at hospital (Likert scale 4.7 vs. 5.9) (P<0.01). CONCLUSIONS: Patients treated with T-PEP showed a lower number of AECOPD. T-PEP improves functional respiratory parameters and improves dyspnea and health status assessment scales. No adherence difference in hospital and home treatment was found. Patients preferred home treatment.
RCT Entities:
BACKGROUND: Temporary positive airway pressure (T-PEP) is a tool recently introduced in the treatment of chronic obstructive pulmonary disease (COPD) or bronchiectasis. It demonstrated encouraging results also in severe COPDpatients. The aim of this study is verify if adding T-PEP to best bronchodilator therapy both in clinic and home administering could reduce disease exacerbations and improve lung function in patients with severe COPD. METHODS: A total of 142 patients with severe COPD (FEV1 <50%) were enrolled; 120 were randomized in three groups: a group treated with T-PEP at home, a group with T-PEP at hospital and a group with medical therapy only (control group). Number of acute exacerbations COPD (AECOPD) after 1 month and 3 months were the primary outcomes. Secondary outcomes were changes in respiratory function parameters (FVC, FEV1, TLC, RV), arterial blood gases, dyspnea and health status assessment scales (Modified Medical Research Council (MMRC), Breathlessness, Cough and Sputum scale (BCSS) and COPD Assessment Test (CAT). The time of daily use of the T-PEP was registered as well as its acceptance using a Likert scale. RESULTS: Ninety-nine patients completed the study. Both the groups who used T-PEP showed a statistical lower number of AECOPD after 1 month and 3 months (P<0.01). Some respiratory functional parameters improved in the two groups treated with T-PEP (FVC, FEV1, RV) (P<0.02) and dyspnea and health status assessment scales (MMRC, BCSS, CAT) (P<0.04; P<0.01; P<0.009). The time of daily using was similar in the two T-PEP groups. Patients treated at home showed a greater acceptance than those treated at hospital (Likert scale 4.7 vs. 5.9) (P<0.01). CONCLUSIONS:Patients treated with T-PEP showed a lower number of AECOPD. T-PEP improves functional respiratory parameters and improves dyspnea and health status assessment scales. No adherence difference in hospital and home treatment was found. Patients preferred home treatment.
Entities:
Keywords:
Severe chronic obstructive pulmonary disease; home administering; hospital administering; temporary expiratory pressure (T-PEP)
Authors: M R Miller; J Hankinson; V Brusasco; F Burgos; R Casaburi; A Coates; R Crapo; P Enright; C P M van der Grinten; P Gustafsson; R Jensen; D C Johnson; N MacIntyre; R McKay; D Navajas; O F Pedersen; R Pellegrino; G Viegi; J Wanger Journal: Eur Respir J Date: 2005-08 Impact factor: 16.671