COMET: a multicomponent home-based disease-management programme versus routine care in severe COPD.

The COPD Patient Management European Trial (COMET) investigated the efficacy and safety of a home-based COPD disease management intervention for severe COPD patients.The study was an international open-design clinical trial in COPD patients (forced expiratory volume in 1 s <50% of predicted value) randomised 1:1 to the disease management intervention or to the usual management practices at the study centre. The disease management intervention included a self-management programme, home telemonitoring, care coordination and medical management. The primary end-point was the number of unplanned all-cause hospitalisation days in the intention-to-treat (ITT) population. Secondary end-points included acute care hospitalisation days, BODE (body mass index, airflow obstruction, dyspnoea and exercise) index and exacerbations. Safety end-points included adverse events and deaths.For the 157 (disease management) and 162 (usual management) patients eligible for ITT analyses, all-cause hospitalisation days per year (mean±sd) were 17.4±35.4 and 22.6±41.8, respectively (mean difference -5.3, 95% CI -13.7 to -3.1; p=0.16). The disease management group had fewer per-protocol acute care hospitalisation days per year (p=0.047), a lower BODE index (p=0.01) and a lower mortality rate (1.9% versus 14.2%; p<0.001), with no difference in exacerbation frequency. Patient profiles and hospitalisation practices varied substantially across countries.The COMET disease management intervention did not significantly reduce unplanned all-cause hospitalisation days, but reduced acute care hospitalisation days and mortality in severe COPD patients.

Inspiratory muscle training during rehabilitation in successfully weaned hypercapnic patients with COPD.

BACKGROUND: This study is aimed to evaluate the effect of inspiratory muscle training (IMT) added to rehabilitation in patients with chronic obstructive pulmonary disease (COPD) who remain hypercapnic and use non-invasive ventilation after successful weaning. METHODS: Patients received rehabilitation and were randomized to inspiratory muscle or sham training for 4 weeks. The primary outcome was distance walked within 6 min. Secondary outcomes were inspiratory muscle strength, endurance, lung function, and blood gas levels. RESULTS: Twenty-nine patients participated in this study. Walking distance of the sham group increased from 93 ± 52 m at baseline to 196 ± 85 m at week 4 (p = 0.019, 95% CI: 11-196 m). Patients in the IMT group significantly improved their walking distance from 94 ± 32 to 290 ± 75 m (p < 0.0001 [107-286 m]; p = 0.04 [3-186 m] for between-group comparison). Patients in the IMT group increased their maximal inspiratory pressure from -35 ± 8 to -55 ± 11 cmH2O (p = 0.001; -6 to -33 cmH2O), while the increase in the sham group failed to reach significance (-29 ± 10 to -37 ± 13 cmH2O [-22 to 6 cmH2O]). Inspiratory power increased from 9.6 ± 5.4 to 20.7 ± 9.7 joules/min (2.6-19.5 joules/min, p = 0.003) in the IMT group, while no significant change occurred in the sham group (7.6 ± 4.2 joules/min at study entry and 11.1 ± 6.9 joules/min [-5.2-12.3 joules/min] at study end). CONCLUSIONS: Rehabilitation of successfully weaned patients with COPD and persistent hypercapnia significantly improves functional exercise capacity. Additional IMT significantly enhances functional exercise capacity and increases respiratory muscle strength and power.