Table 1.
Trials | No of patients | Publication status | Industry sponsored trials | Mean age (years) | % male | Baseline FEV1 (mean % predicted) | Atopy | Dose optimisation before randomisation | Drug (dose) of anti- leukotrienes‡ | Inhaled glucocorticoids
|
Duration of treatment (weeks) | Intention to treat analyses | Reported outcomes
|
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---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Drug | Intervention group | Control group | Exacerbations requiring systemic steroids | Steroid dose reduction | |||||||||||||||
Anti-leukotrienes versus placebo as add-on therapy to inhaled glucocorticoids | |||||||||||||||||||
Laviolette et al9 | 393 | Yes | Merck | 40 | 54 | 72 | 75 | Montelukast (10 mg once daily) | Beclomethasone diproprionate | 400 μg | 400 μg | 16 | Yes | No | |||||
Simons et al14† |
279 | Yes | Merck | 10 | 67 | 78 | 72 | Montelukast (5 mg once daily) | Budesonide | 400 μg | 400 μg | 4 | Yes | Yes | |||||
Tamaoki et al7 | 79 | Yes | No | 48 | 43 | 80* | Not reported | Pranlukast (450 mg twice daily) | Beclomethasone diproprionate | 750 μg | 750 μg | 6 | Not reported | Yes | |||||
Tomita et al18 | 41 | Yes | Not reported | 50 | 60 | 88* | 66 | Pranlukast (450 mg once daily) | Beclomethasone diproprionate | 400 μg | 400 μg | 8 | Not reported | No | |||||
Virchow et al8 | 368 | Yes | Astra-Zeneca | 48 | 51 | 64 | 46 | Zafirlukast (80 mg twice daily) | Beclomethasone diproprionate | 1598 ± 381 μg | 1650 ± 456 μg | 6 | Yes | Yes | |||||
Wada et al15 | 80 | Yes | No | 50 | 50 | 74 | 53 | Pranlukast (225 mg twice daily) | Beclomethasone diproprionate | 1048 ± 237 μg | 1127 ± 307 μg | 4 | Not reported | No | |||||
Anti-leukotrienes as add-on therapy to inhaled glucocorticoids versus double dose of inhaled glucocorticoids | |||||||||||||||||||
Nayak et al17 | 394 | No | Astra-Zeneca | 39 | 38 | 67 | 94 | Zafirlukast (40 mg or 80 mg twice daily) | Beclomethasone diproprionate | 400 μg | 800 μg | 13 | No | Yes | |||||
Ringdal et al16 | 440 | No | Astra-Zeneca | 41 | 49 | 85 | Not reported | Zafirlukast (20 mg or 80 mg twice daily) | Beclomethasone diproprionate | 400-500 μg | 800-1000 μg | 12 | No | Yes | |||||
Anti-leukotrienes versus placebo as add-on therapy to tapering doses of inhaled glucocorticoids | |||||||||||||||||||
Baba et al21 | 24 | No | Not reported | Not reported | Not reported | Not reported |
Not reported | Not reported | Pranlukast (not reported) | Beclomethasone diproprionate | Not reported | Not reported | Not reported | Not reported | No | No | |||
Bateman et al19 | 359 | No | Astra Zeneca | 42 | 45 | 2.6L | 48 | 0 | Zafirlukast (20 mg twice daily) | Beclomethasone diproprionate or Budesonide | 400-750 μg | 400-750 μg | 20 | Yes | No | Yes | |||
Laitinen et al20 | 262 | No | Astra Zeneca | 44 | 42 | 2.5L | 43 | 2 weeks to 3 months | Zafirlukast (20 mg twice daily) | Beclomethasone diproprionate or Budesonide | 800-2000 μg | 800-2000 μg | 12 | No | No | Yes | |||
Lofdahl et al6 | 226 | Yes | Merck | 40 | 43 | 83 | Not reported | ⩽7 weeks | Montelukast (10 mg once daily) | Various‡ | 300-3000 μg | 300-3000 μg | 12 | Yes | No | Yes | |||
Shingo et al22 | 22 | No | Merck | 39 | 41 | 84 | Not reported | 0 | Montelukast (10 mg once daily) | Various§ | 1600 μg | 1350 μg | 8 | Yes | Yes | No |
FEV1=forced expiratory volume in one second. Anti-leukotriene licensed doses for adults: Montelukast: 10 mg once daily (5 mg for children aged 5 to 14 years), Pranlukast 225 mg twice daily, Zafirlukast 20 mg twice daily. No trial reported use of inhaled glucocorticoids propelled by hydrofluorocarbons. *Reported spirometry before abrupt reduction by half of maintenance dose of inhaled glucocorticoids.† Cross over study. ‡Reported use of beclomethasone dipropionate (16%), budesonide (22%), flunisolide(15%), fluticasone propionate (7%), and triamcinolone acetonide (40%). Corticosteroids dose reduction not been provided in μg of “chlorofluorocarbon propelled beclomethasone diproprionate equivalent” (T R Reiss, personal communication, 2000). §Reported use of triamcinolone acetonide (72%), flunisolide (18%), and beclomethasone dipropionate (9%).