Changes in lung function
ITT baseline | n | Completers baseline | n | Completers 12 months | n | Change over 1 year | n | |
---|---|---|---|---|---|---|---|---|
FEV1 (litres) | ||||||||
NIV | 0.67 (0.23) | 99 | 0.70 (0.24) | 48 | 0.71 (0.30) | 48 | 0.01 (−0.05 to 0.08) | 48 |
Controls | 0.65 (0.23) | 95 | 0.72 (0.26) | 46 | 0.76 (0.32) | 46 | 0.04 (−0.03 to 0.11) | 46 |
Treatment effect | −0.024 (−0.12 to 0.07) | |||||||
VC (litres) | ||||||||
NIV | 2.1 (0.7) | 98 | 2.1 (0.70) | 49 | 2.2 (0.78) | 49 | 0.09 (−0.09 to 0.27) | 49 |
Controls | 2.3 (0.8) | 95 | 2.3 (0.75) | 46 | 2.4 (0.74) | 46 | 0.13 (−0.08 to 0.34) | 46 |
Treatment effect | −0.036 (−0.31 to 0.23) |
Data presented as means (±SD) and mean change (95% CIs); controls, standard treatment. There were no significant changes after 12 months in lung function within or between the groups.
FEV1, forced expiratory volume in one second, postbronchodilator; ITT, intention-to-treat; n, numbers for analysis; NIV, non-invasive positive pressure ventilation; VC, vital capacity.