Characteristics of included trials and observational studies
| (A) Randomised controlled trials | ||||||||
|---|---|---|---|---|---|---|---|---|
| Source | Location | Treatment duration | Asthma criteria | Drug and inhaler device | Male % | Mean age (years) | Mean % predicted FEV1 | Prior ICS use (%) |
| CAMP/Kelly et al15 32 | Multicentre US | >208 weeks | Mild-to-moderate asthma defined by symptoms or by use of inhaled bronchodilator ≥ twice weekly or daily medication for asthma. Airway methacholine challenge test | BUD 200 µg bd (n=311) | 58.2 | 9.0 | 93.6 | 40.5 |
| Nedocromil 8 mg daily (n=312) | 66.0 | 8.8 | 93.4 | 36.5 | ||||
| Placebo (n=412) | 56.0 | 9.0 | 94.2 | 35.9 | ||||
| Ferguson et al 200714 | Multicentre—35 centres in 11 countries | 52 weeks | Age 6–9 years persistent asthma ≥6 months; FEV1 ≥ 60% predicted; ↑PEFR of ≥15% after salbutamol. Exclusions: oral corticosteroids on >2 occasions or >12 days or >210 mg prednisolone past 6 months; known growth disorder or glaucoma/cataracts | FP 100 μg bd (n=114) Diskus (dry powder inhaler) | 68 | 7.2 | 90.2 | 25% oral steroids past 6 months |
| BUD 200 μg bd (n=119) Turbuhaler | 70 | 7.4 | 92.3 | 21% oral steroids past 6months | ||||
| Kemp et al16 | Multicentre US | 104 weeks | 6-month history of mild asthma (FEV1 82–85% predicted) able to be managed without steroids for 2 years | FP 88 µg bd (n=55) Metered dose inhaler | 60 | 31.6 | 83 | 0 |
| FP 440 µg bd (n=51) Metered dose inhaler | 59 | 29.0 | 82 | 0 | ||||
| Placebo (n=54) | 59 | 28.4 | 85 | 0 | ||||
| Li et al17 | Multicentre US | 104 weeks | At least 6-month history with diagnosis using American Thoracic Society definition. FEV1 of ≥60% predicted, and limited previous corticosteroid therapy | FP 500 μg bd (n=32) Diskhaler | 91 | 28.0 | 91 | Not reported |
| Placebo bd (n=32) Diskhaler | 81 | 31.1 | 91 | Not reported | ||||
| Maspero et al18 | 50 centres worldwide | 52 weeks | Adults with >3 months history of asthma, and not using ICS past 3 months. FEV1 between 60 and 90% predicted. Must have DEXA scan, and no evidence of low vitamin D | Mometasone 400 µg daily (n=137) | 34 | 30 | 76.5 | 7 |
| Mometasone 200 µg daily (n=140) | 35 | 30 | 74.7 | 7 | ||||
| FP 250 µg bd (n=147) | 39 | 28 | 75.3 | 6 | ||||
| Montelukast 10 mg (n=142) | 38 | 28 | 76.9 | 10 | ||||
| Roux et al19 | 52 respiratory specialist clinics in France | 104 weeks | Exacerbations ≥1×/week but <1× daily; or chronic symptoms requiring daily treatment. Fulfilling: (1) FEV1 or PEFR ≥80% predicted; (2) reversibility ≥15%; (3) daily variability PEFR 20%–30% ≥2 days, or salbutamol use >3 times previous week, or nocturnal symptoms ≥2× during run-in | FP 100 μg bd (n=87) Diskus/Accuhaler dry powder inhaler | 64 | 9.1 | 88.9 | Not reported |
| Nedocromil 4 mg bd (n=87) MDI | 66 | 9.4 | 88.5 | Not reported | ||||
| Turpeinen et al20 | Helsinki University Hospital, Finland | 72 weeks | ‘Newly detected mild asthma’ Excluded if history of inhaled, nasal or oral corticosteroid use in the previous 2 months before enrolment | Continuous BUD (n=50) Turbuhaler BUD 400 μg bd for 1 month, then 200 μg bd for 2nd–6th months, then 100 μg bd for final 12 months. | 60 | 6.9 | Not reported | Not reported |
| BUD/placebo (n=44) Turbuhaler BUD 400 μg bd for 1st month, then 200 μg bd for 2nd to 6th months, then placebo for final 12 months | 66 | 6.7 | Not reported | Not reported | ||||
| Sodium cromoglicate—10 mg tds for 18 months (unblinded) (n=42) MDI | 50 | 7.0 | Not reported | Not reported | ||||
Bd, two times a day; BUD, budesonide; DEXA, dual-energy X-ray absorptiometry; FEV1, forced expiratory volume in 1 s; FP, fluticasone propionate; ICS, inhaled corticosteroids; MDI, metered dose inhaler; PEFR, peak expiratory flow rate.