Table 1

Summary of baseline demographics and clinical characteristics (pooled population from PALLADIUM and IRIDIUM studies; full analysis set)

High-dose MF/IND
(320/150 µg) one time a day (n=1054)
Medium-dose MF/IND
(160/150 µg) one time a day (n=1044)
High-dose FLU/SAL
(500/50 µg) two times a day (n=1056)
PALLADIUM (n=443)
IRIDIUM (n=611)
PALLADIUM (n=437)
IRIDIUM (n=607)
PALLADIUM (n=444)
IRIDIUM (n=612)
Age, years49.9±13.7450.0±13.8551.2±13.39
Gender, n (%)
 Female638 (60.5)621 (59.5)666 (63.1)
Duration of asthma, years*15.9±13.8716.6±14.6116.8±14.56
Baseline ACQ-7 score†2.4±0.562.4±0.522.4±0.53
Number of asthma exacerbations in the 12 months prior to screening, n (%)
 0305 (28.9)308 (29.5)300 (28.4)
 1608 (57.7)566 (54.2)600 (56.8)
 >1141 (13.4)170 (16.3)156 (14.8)
Pre-bronchodilator FEV1 (% predicted) prior to run-in visit59.0±12.9859.4±12.9759.6±12.72
FEV1 reversibility (%) prior to run-in visit‡25.9±17.6225.6±17.2226.0±18.92
Prior asthma treatment; n (%)§
 Medium-/high-dose ICS/LABA634 (59.6)623 (59.0)629 (59.1)
 Low-dose ICS/LABA316 (29.7)299 (28.3)302 (28.4)
 ICS monotherapy107 (10.1)119 (11.3)123 (11.6)
  • Data are presented as mean±SD unless otherwise specified.

  • *Duration of asthma was calculated from the start date of asthma recorded on the eCRF until the date of screening.

  • †The baseline ACQ-7 score was reported at screening, or if missing, at the last visit from run-in.

  • ‡FEV1 reversibility was calculated as increase of FEV1 value after inhalation of bronchodilator (400 µg salbutamol/360 µg albuterol, or equivalent dose) relative to FEV1 value before inhalation of bronchodilator.

  • §The summary of baseline medication is based on randomised set population included in the PALLADIUM and IRIDIUM studies (high-dose MF/IND, n=1063; medium-dose MF/IND, n=1056; high-dose FLU/SAL, n=1064). All other parameters included are based on full analysis set from both the studies.

  • ACQ, Asthma Control Questionnaire; FEV1, forced expiratory volume in 1 s; FLU/SAL, fluticasone propionate/salmeterol xinafoate; ICS, inhaled corticosteroid; LABA, long-acting β2-agonist; MF/IND, mometasone furoate/indacaterol acetate; n, number of patients.