TABLE 1

Characteristics of 14 Multicenter, Randomized, Double-Blind, and Parallel-Group Trials

Study (Year), Country, SponsorDuration, wkAge, yMale, %Inclusion CriteriaIntervention and ComparisonOutcomes
Allen et al15 (1998); United States; GlaxoSmithKline524–1175Mild-to-moderate asthma-ATS criteria; 46% received ICSs before entry; entry criteria for FEV1: ≥60% predictedFLU Diskhaler 100 μg/d BID (n = 111); FLU Diskhaler 200 μg/d BID (n = 108); placebo (n = 106)Linear growth rate (cm/y), adverse events
Katz et al14 (1998); France, Finland, Israel, Italy, Hong Kong, Portugal, Spain, Singapore, United Arab Emirates; GlaxoSmithKline124–1163.1Mild asthma; no treatment with ICSs 3 mo before entry; mean baseline PEF: 82% predictedFLU DPI 100 μg/d BID (n = 85); FLU DPI 200 μg/d BID (n = 86); placebo (n = 92)FEV1, PEF, asthma symptom score, β2-agonist use, nighttime awakenings, adverse events
Peden et al16 (1998); United States; GlaxoSmithKline124–1162.6Moderate asthma-ATS criteria; all required maintenance treatment before entry; entry criteria for FEV1: 50%–85% predictedFLU Diskus 100 μg/d BID (n = 90); FLU Diskus 200 μg/d BID (n = 87); FLU Diskhaler 100 μg/d BID (n = 91); FLU Diskhaler 200 μg/d BID (n = 83)FEV1, PEF, asthma symptom score, β2-agonist use, nighttime awakenings, adverse events, morning plasma cortisol levels, 24-h urine cortisol/creatinine concentrations
Shapiro et al47 (1998); United States; Astra USA, Inc124–861.8Moderate-to-severe asthma-NIH criteria; all required ICSs before entry; entry criteria for FEV1: ≥50% predictedBUD nebulizer 0.5 mg/d BID (n = 47); BUD nebulizer 1.0 mg/d BID (n = 42); BUD nebulizer 2.0 mg/d BID (n = 45); placebo (n = 44)FEV1, PEF, asthma symptom score, β2-agonist use, adverse events, basal and adrenocorticotrophic hormone–stimulated plasma cortisol levels
Shapiro et al48 (1998); United States; Astra USA, Inc126–1877.7Moderate-to-severe asthma; all required ICSs before entry; entry criteria for FEV1: ≥50% to ≤85% predictedBUD Turbuhaler 200 μg/d BID (n = 102); BUD Turbuhaler 400 μg/d BID (n = 100); BUD Turbuhaler 800 μg/d BID (n = 99); placebo (n = 103)FEV1, PEF, asthma symptom score, β2-agonist use, adverse events, basal and adrenocorticotrophic hormone–stimulated plasma cortisol levels
Verberne et al49 (1998); Netherlands; GlaxoSmithKline546–1658.0Mild-to-moderate asthma-ATS criteria; all received ICSs before enrollment; entry criteria for FEV1: 55%–90% predictedBDP Diskhaler 400 μg/d BID (n = 57); BDP Diskhaler 800 μg/d BID (n = 60); BDP 400 μg/d + SAL 100 μg/d BID (n = 60)FEV1, PEF, asthma symptom score, β2-agonist use, airway hyperresponsiveness, adverse events
Shapiro et al12 (2001); United States; Astra USA, Inc126–1764.9Mild-to-moderate asthma-ATS criteria; all received ICSs before entry; entry criteria for FEV1: ≥65% to ≤90% predictedBUD Turbuhaler 200 μg/d QD (n = 90); BUD Turbuhaler 400 μg/d QD (n = 93); placebo (n = 91)FEV1, PEF, asthma symptom score, β2-agonist use, adverse events
Nayak et al13 (2002); United States; 3M Pharmaceuticals125–1263.5Moderate asthma; entry criteria for FEV1: 50%–80% predictedBDP HFA Autohaler 80 μg/d BID (n = 120); BDP HFA Autohaler 160 μg/d BID (n = 117); placebo (n = 116)FEV1, PEF, asthma symptom score, β2-agonist use, adverse events, morning plasma cortisol levels
Verona et al50 (2003); Bulgaria, Croatia, Hungary, Poland, Russia; GlaxoSmithKline524–1472.0History of asthma requiring high-dose ICSs for ≥4 wk before entry; mean baseline PEF: 255–257 L/minFLU Diskus 200 μg/d BID (n = 267); FLU Diskus 400 μg/d BID (n = 261)PEF, asthma symptom score, β2-agonist use, adverse events, 12-h urine cortisol/creatinine levels
Berger et al44 (2006); United States; Schering-Plough Corp124–1162.9Mild-to-moderate asthma; all received ICSs before entry; entry criteria for FEV1: ≥60% to ≤85% predictedMOM DPI 100 μg/d QD (n = 98); MOM DPI 200 μg/d QD (n = 99); placebo (n = 99)FEV1, PEF, FVC, FEF25%-75%, asthma symptom score, HRQoLQ, adverse events
Gelfand et al45 (2006); United States, Mexico, Poland; Aventis Pharmaceuticals124–11Moderate-to-severe asthma, NIH criteria (59.4% moderate, 24.1% severe); entry criteria for FEV1: ≥40% to ≤90% predictedCIC HFA MDI 40 μg/d QD (n = 252); CIC HFA MDI 80 μg/d QD (n = 259); CIC HFA MDI 160 μg/d QD (n = 253); placebo (n = 254)FEV1, PEF, asthma symptom score, β2-agonist use, HRQoLQ, adverse events, 24-h urine cortisol/creatinine levels
Skoner et al17 (2008); Argentina, Chile, United States, Venezuela; Sanofiaventis, Altana, Nycomed525–8.567.2Mild asthma, NIH criteria; no treatment with ICSs 30 d before entry; entry criteria for FEV1: ≥80% predictedCIC HFA MDI 40 μg/d QD (n = 221); CIC HFA MDI 160 μg/d QD (n = 219); placebo (n = 221)Linear growth rate (cm/y), adverse events, 24-h urine cortisol/creatinine concentrations
Pedersen et al46 (2009); Brazil, Germany, Hungary, Poland, Portugal, South Africa; Nycomed126–1165.4Moderate-to-severe asthma-ATS criteria (32.3% moderate, 54.8% severe); 49.2% used ICSs before entry; entry criteria for FEV1: 50%–90% predictedCIC HFA MDI 80 μg/d QD (n = 252); CIC HFA MDI 160 μg/d QD (n = 242); FLU HFA MDI 176 μg/d BID (n = 250)FEV1, PEF, asthma symptom score, β2-agonist use, airway hyperresponsiveness, HRQoLQ, adverse events, 24-h urine cortisol/creatinine concentrations
FLIP3951; Belgium, Eire, Finland, Israel, Italy, Netherlands, United Kingdom; GlaxoSmithKline126–16Moderate-to-severe asthma; all received ICSs for before entry; entry criteria for PEF: ≤95% predictedFLU DPI 100 μg/d BID (n = 97); FLU DPI 200 μg/d BID (n = 99)FEV1, PEF, asthma symptom score, β2-agonist use, nighttime awakenings, adverse events.
  • ATS indicates American Thoracic Society; FLU, fluticasone; BID, twice daily; NIH, National Institutes of Health; BUD, budesonide; SAL, salmeterol; MOM, mometasone; QD, once daily; HRQoLQ, health-related quality-of-life questionnaire; CIC, ciclesonide; HFA, hydrofluoroalkane; —, data not available.