| Study (treatment group) | Study design | ICS agent/total dose/day* | Treatment duration (weeks) | Patients (n)† | Age (y)‡ | Sex (M/F) (%) | FEV1 at baseline‡ (% pred) (SD) |
| Laviolette 199918 Montelukast/ICS Placebo/ICS | RCT, PC, ICS constant | Bec400 μg | 16 | 193200 | 40§ (15–76)39§ (15–78) | 56/4452/48 | 72 (12)71 (12) |
| Riccioni 200219 Montelukast/ICS ICS | RCT, ICS constant | Bud800 μg | 16 | 1515 | 28 (10)27 (12) | 33/6753/47 | 99 (na)97 (na) |
| Vaquerizo 200320 Montelukast/ICS Placebo/ICS | RCT, PC, ICS constant | Bud400–1600 μg | 16 | 326313 | 42 (15)44 (16) | 62/3861/39 | 81 (19)81 (21) |
| Kanniess 200221 | RCT, PC, ICS | Bec¶ | |||||
| Montelukast/ICS | Tapered | 400 μg | 12 | 26 | 38 (12) | 50/50 | 95 (10) |
| Placebo/ICS | 24 | 43 (11) | 46/54 | 92 (9) | |||
| Löfdahl 199922 | RCT, PC, ICS | Various** | |||||
| Montelukast/ICS | Tapered | 300–3000 μg | 12 | 113 | 40 (17–70) | 42/58 | 85 (11) |
| Placebo/ICS | 113 | 41 (16–68) | 54/46 | 82 (13) | |||
| Riccioni 200523 | RCT, | Bud¶ | |||||
| Montelukast/ICS | ICS | 800 μg | 12 | 20†† | 39 (15) | 45/55 | 91 (14) |
| ICS | Tapered | 20†† | 38 (13) | 50/50 | 91 (10) | ||
| Tohda 200224 Montelukast/ICS Placebo/ICS | RCT, PC, ICS tapered | Bec**400–800 μg | 24 | 8484 | na‡‡ | 58/4258/42 | 87 (18)86 (25) |
| Bjermer 200325 42 Montelukast/ICS Salmeterol/ICS | RCT, AC, ICS constant | Flu200 μg | 48 | 747743 | 41 (14)41 (14) | 45/5545/55 | 71 (13)73 (14) |
| Grosclaude 200327 Montelukast/ICS Salmeterol/ICS | RCT, AC, ICS constant | Bec1000 μg (ML)Flu500 μg (AC) | 12 | 127119 | 45 (na)43 (na) | 39/6139/61 | na |
| Ilowite 200428 43 Montelukast/ICS Salmeterol/ICS | RCT, AC, ICS constant | Flu220 μg | 48 | 743730 | 39 (14–73)38 (15–70) | 41/5938/63 | 74 (12)74 (12) |
| Nelson 200029 44 45 Montelukast/ICS Salmeterol/ICS | RCT, AC, ICS constant | Flu200 μg | 12 | 225222 | 43 (14)40 (14) | 40/6039/61 | 71 (8)70 (7) |
| Ringdal 200330 46 47 Montelukast/ICS Salmeterol/ICS | RCT, AC, ICS constant | Flu200 μg | 12 | 369356 | 43 (14–79)43 (15–75) | 45/5546/54 | 74 (16)76 (15) |
| SAM40030 200326 48 Montelukast/ICS Salmeterol/ICS | RCT, AC, ICS constant | Flu200 μg | 12 | 3333 | 34 (8)36 (8) | 58/4245/55 | 76 (7)75 (9) |
*In each treatment group (unless otherwise stated); †number of patients analysed for baseline data; ‡mean (SD or range); §median; ¶tapered according to protocol: dose halved after 6 weeks21; dose halved after 4, 8 and 12 weeks23; **tapered according to clinical symptoms; ††number of patients who completed the study; and ‡‡in the publication, the number of patients per age cohort is given.
References 42–44 and 46 refer to unpublished study reports.
AC, active controlled (salmeterol); Bec, beclamethasone; Bud, budesonide; FEV1, forced expiratory volume in 1 s; Flu, fluticasone; ICS, inhaled corticosteroids; ML, montelukast; na, not available; PC, placebo controlled; RCT, randomised controlled trial.