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Table 2 Results for primary, secondary and selected other endpoints (intent-to-treat population)

From: Efficacy and safety of once-daily fluticasone furoate 50 mcg in adults with persistent asthma: a 12-week randomized trial

  Endpoint Placebo OD PM (N = 111) FF 50 mcg OD PM (N = 111)  
   n Mean (SE) n Mean (SE) Difference (95% CI)
Pre-dose evening FEV1a, L Primary 106 0.038 (0.0333) 108 0.157 (0.0330) 0.120* (0.026, 0.213)
Rescue-free 24-h periodsb, % Secondary (powered) 110 17.1 (2.78) 111 28.7 (2.77) 11.6*(3.8, 19.4)
Evening PEFb, L/min Secondary 110 19.5 (3.72) 111 22.8 (3.70) 3.3 (−7.2, 13.7)
Morning PEFb, L/min Secondary 110 22.9 (3.65) 111 34.5 (3.64) 11.6 (1.4, 21.9)
Symptom-free 24-h periodsb, % Secondary 110 14.0 (2.49) 111 22.6 (2.47) 8.6 (1.6, 15.6)
    Number of patients   Number of patients  
Withdrawal due to lack of efficacyb, % Secondary   14   6  
   n Mean (SE) n Mean (SE) Difference (95% CI)
Asthma Control Test™ (ACT) scorea Other 92 4.0 (0.39) 100 6.2 (0.38) 2.2 (1.1, 3.3)
   n Number of patients n Number of patients Odds Ratio (95% CI)
Patients with ACT score ≥20a, % Other 92 55 100 69 1.88 (0.97, 3.65)
   n Mean (SE) n Mean (SE) Difference (95% CI)
Total Asthma Quality of Life Questionnaire (AQLQ) + 12 scorea Other 92 0.84 (0.097) 100 1.30 (0.093) 0.45 (0.18, 0.72)
  1. Change from baseline: aat Week 12, bduring or averaged over Weeks 1–12. *statistically significant. FEV1 = forced expiratory volume in one second; PEF = peak expiratory flow; FF = fluticasone furoate; OD = once daily; PM = evening; SE = standard error; CI = confidence interval.