Mean (SD) baseline values and changes from baseline in diary card primary variables during primary period (last six weeks of treatment)
| Variable | Nedocromil sodium | Placebo | p value | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline (n = 38) | Weeks 6 to 12—baseline (n = 33) | Baseline (n = 40) | Weeks 6 to 12—baseline (n = 36) | Baseline | Weeks 6 to 12—baseline | ||||||
| Daytime asthma | 1.6 (0.72) | −0.8 (1.04) | 1.4 (0.62) | −0.4 (0.74) | 0.331 | 0.030 | |||||
| Night time asthma | 1.6 (0.63) | −1.0 (0.66) | 1.3 (0.46) | −0.3 (0.81) | 0.037 | 0.001 | |||||
| Morning PEF (l/min) | 222.7 (72.12) | 23.8 (28.08) | 227.2 (74.33) | 4.1 (45.47) | 0.778 | 0.036 | |||||
| Evening PEF (l/min) | 231.9 (71.72) | 16.8 (38.82) | 241.2 (75.11) | −5.6 (45.74) | 0.582 | 0.033 | |||||
| Bronchodilator use (doses/24 hours) | 2.3 (1.8) | −0.9 (2.16) | 1.9 (2.00) | −0.1 (1.59) | 0.131 | 0.011 | |||||
| Patient/parent opinion of efficacy: | |||||||||||
| Very effective | 17 | 9 | |||||||||
| Moderately effective | 3 | 9 | |||||||||
| Slightly effective | 5 | 5 | 0.059 | ||||||||
| No effect | 3 | 3 | |||||||||
| Made condition worse | 4 | 9 | |||||||||
| Not recorded | 6 | 6 | |||||||||
PEF = peak expiratory flow.
p values are for comparisons between nedocromil and placebo groups.