Variable | Nedocromil sodium | Placebo | p value | ||||||||
---|---|---|---|---|---|---|---|---|---|---|---|
End of baseline | Change at final visit (end of week 12) | End of baseline | Change at final visit (end of week 12) | Baseline | Final visit—baseline | ||||||
Daytime asthma | 2.29 (0.927) | −1.03 (1.571) | 2.12 (0.748) | −0.36 (1.959) | 0.607 | 0.149 | |||||
Night time asthma | 2.18 (0.865) | −1.0 (1.904) | 2.10 (1.044) | −0.22 (2.282) | 0.790 | 0.120 | |||||
FEV1 (l) | 1.45 (0.497) | 0.14 (0.234) | 1.54 (0.549) | 0.06 (0.187) | 0.448 | 0.150 | |||||
FVC (l) | 1.91 (0.582) | 0.22 (0.347) | 2.00 (0.593) | 0.23 (0.440) | 0.469 | 0.859 | |||||
PEF (l/min) | 215.32 (65.702) | 14.29 (41.672) | 216.78 (69.316) | 13.93 (31.89) | 0.925 | 0.739 | |||||
Investigator opinion of efficacy | |||||||||||
Very effective | 6 | 2 | |||||||||
Moderately effective | 9 | 11 | |||||||||
Slightly effective | 8 | 7 | 0.180 | ||||||||
No effect | 6 | 7 | |||||||||
Made condition worse | 4 | 8 | |||||||||
Not recorded | 5 | 5 |
FEV1 = forced expiratory volume in one second; FVC = forced vital capacity; PEF = peak expiratory flow.
p values are for comparisons between nedocromil and placebo groups.