TABLE 6

Exploratory subgroup analyses of relative change in forced expiratory volume in 1 s (FEV1) from baseline to 56 days

Subjects nEstimateFEV1# %sep-value
Modified ITT560.03313.30.02590.2074
Modified ITT with study drug compliance ≥100%29−0.0137−1.40.02500.5869
Modified ITT with study drug compliance <100%270.08548.50.04490.0690
Modified ITT age ≤25 years130.09539.50.07180.2115
Modified ITT age >25 years43−0.0072−0.70.02590.7827
Modified ITT on tobramycin150.158515.80.05220.0095
Modified ITT not on tobramycin41−0.0058−0.60.02710.8330
Modified ITT on aztreonam130.08368.40.05050.1264
Modified ITT not on aztreonam430.03613.60.03060.2447
Modified ITT on antibiotics and with study drug compliance <100%240.110111.00.04600.0257
Modified ITT on continuous inhaled antibiotics400.05915.90.02950.0521
Modified ITT on continuous inhaled antibiotics and with study drug compliance <100%190.128212.80.05010.0204
Modified ITT on tobramycin and with study drug compliance <100%90.199620.00.08500.0512
Modified ITT with BMI <20 kg·m2 at screening160.121412.00.06460.0810
Modified ITT with BMI ≥20 kg·m2 at screening400.01691.70.02580.5171
Modified ITT with FEV1 <55% predicted at screening210.03984.00.04690.4066
Modified ITT with FEV1 55–70% predicted at screening190.01661.70.03320.6230
Modified ITT with FEV1 >70% predicted at screening160.06216.20.05760.2992

Estimates of treatment differences from mixed models. ITT: intention-to-treat population; BMI: body mass index. #: percentage change in FEV1 compared to placebo. Tobramycin treatment was always synchronised in the off-cycle.