Table 1
Characteristics of patients in each of the five multicentre trials by treatment group
| Trial A | Trial B | Trial C | Trial D | Trial E | Integrated data set | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Zafirlukast | Placebo | Zafirlukast | Placebo | Zafirlukast | Placebo | Zafirlukast | Placebo | Zafirlukast | Placebo | Zafirlukast | Placebo | ||||||
| No. patients | 43 | 46 | 514 | 248 | 96 | 95 | 88 | 80 | 231 | 223 | 972 | 692 | |||||
| M/F (%) | 51/49 | 54/46 | 57/43 | 59/41 | 55/45 | 53/47 | 58/42 | 49/51 | 45/55 | 41/59 | 54/46 | 51/49 | |||||
| Mean (SD) age (years) | 35 (11) | 33 (13) | 31 (12) | 31 (13) | 32 (14) | 30 (13) | 34 (13) | 33 (12) | 33 (14) | 32 (13) | 32 (13) | 32 (13) | |||||
| Ethnic origin: white/black/other | 36/4/3 | 38/5/3 | 450/24/40 | 216/12/20 | 84/4/8 | 78/4/13 | 88/0/0 | 80/0/0 | 195/19/17 | 190/17/16 | 853/51/68 | 602/38/52 | |||||
| Mean (SD) FEV1
(% predicted) | 74 (16) | 78 (18) | 78 (16) | 79 (17) | 77 (16) | 78 (17) | 81 (15) | 82 (17) | 67 (11) | 66 (10) | 75 (15) | 75 (16) | |||||
| Mean (SD) daytime asthma symptoms score1-151 | 1.7 (0.4) | 1.6 (0.4) | 1.6 (0.4) | 1.6 (0.4) | 1.7 (0.4) | 1.6 (0.4) | 0.7 (0.5) | 0.8 (0.6) | 1.8 (0.4) | 1.9 (0.4) | 1.6 (0.5) | 1.6 (0.5) | |||||
| Mean (SD) PEF variability (%)* 1-152 | 14.4 (11.2) | 13.2 (10.4) | 13.2 (10.4) | 11.7 (10.2) | 12.4 (8.8) | 14.2 (12.7) | 9.7 (6.6) | 11.0 (8.2) | 3.5 (9.7) | 14.8 (10.2) | 12.9 (9.9) | 13.0 (10.5) | |||||
| Patients with nocturnal awakenings (%) | 63 | 70 | 65 | 56 | 61 | 63 | 41 | 61 | 65 | 65 | 62 | 62 | |||||
↵1-151 In all studies the same 0– 3 scale was used to assess symptoms (0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms, and 3 = severe symptoms). Symptom scores were measured in the week preceding randomisation to study treatment and were recorded by patients on a diary card.
↵1-152
Morning and evening peak expiratory flows (PEF) were measured before β2 agonist use and recorded by patients on a diary card. Baseline values were determined in the week preceding randomisation to study treatment.
