Table 1.
Patient baseline characteristics per study for study A-D and the pilot study
| Study A |
Study B |
Study C |
Study D |
||
|---|---|---|---|---|---|
| Study code |
205.223 |
205.334 |
D5892C00015 |
205.440 |
|
| Sponsor |
BI |
BI |
AZ |
BI |
|
| Reference |
[13] |
[12] |
[30] |
[29] |
|
| ClinicalTrials.gov identifier | NCT00274508 | NCT00530842 | NCT00489853 | NCT01072396 | Pilot study |
| Number of patients | 261 | 344 | 119 | 126 | 15 |
| Age, years | 62 ± 7 | 61 ± 7 | 64 ± 8 | 61 ± 9 | 71 ± 5 |
| Male, % | 72 | 72 | 75 | 52 | 73 |
| Height, cm | 171 ± 9 | 170 ± 8 | 172 ± 8 | 169 ± 9 | 172 ± 9 |
| Weight, kg | 77 ± 17 | 77 ± 17 | 76 ± 16 | 79 ± 14 | 77 ± 12 |
| BMI, kg/m2 | 26 ± 5 | 26 ± 5 | 26 ± 4 | 28 ± 4 | 26 ± 3 |
| Caucasian, % (race) | 100 | 99 | 100 | 91 | 100 |
| Afro-American, % (race) | 0 | 0,6 | 0 | 9 | 0 |
| Current smoker, % | 40 | 44 | 40 | 47 | 7 |
| Pack years | 53 ± 28 | 46 ± 24 | 36 ± 15 | 47 ± 22 | 34 ± 17 |
| COPD duration, years | 9 ± 7 | 8 ± 6 | 10 ± 8 | 5 ± 5 | * |
| LABA user, % | 33 | 52 | 86 | 18 | 53 |
| ICS user, % | 54 | 44 | 39 | 18 | 60 |
| LAMA user, % | 0 | 29 | 44 | 22 | 93 |
| FEV1. L ** | 1.21 ± 0.42 | 1.36 ± 0.40 | 1.12 ± 0.32 | 1.95 ± 0.67 | 1,80 ± 0,44 |
| FEV1. % predicted *** | 39.0 ± 15.6 | 43.8 ± 14.2 | 36.3 ± 18.8 | 66.3 ± 16.7 | 60,3 ± 8,6 |
| FVC. L ** | 2.78 ± 0.83 | 2.85 ± 0.76 | 2.25 ± 0.68 | 3.43 ± 1.05 | 3,62 ± 1,07 |
| FEV1/FVC % ** | 43.9 ± 10.8 | 48.8 ± 11.6 | 51.4 ± 12.6 | 57.1 ± 8.5 | 0,51 ± 0,09 |
Values are mean ± standard deviation unless otherwise specified.
AZ, AstraZeneca; BMI, Body-mass index; BI, Boehringer Ingelheim; FEV1, forced expiratory volume in 1 sec; FVC, Forced vital capacity; ICS, Inhaled corticosteroid; LABA, Long-acting β2 adrenoceptor agonist; LAMA, Long-acting muscarinic receptor antagonist.
* 80% had COPD duration >5 years; 20% had COPD duration 2–5 years
** Pre-bronchodilator (Study A-D); post-bronchodilator (Pilot study).
*** % of predicted normal, calculated according to NHANES III.