Cohort demographics and culture data for baseline samples collected prior to the initiation of chronic TIP/S
Characteristics of patient cohort | Response* | ||
Responder (n=19) (46%) | Non-R† (n=22) (54%) | P value | |
Female | 12 (63) | 11 (50) | 0.4 |
Median age, years (IQR) | 29.2 (24.2–38.6) | 30.4 (23.8–34.5) | 0.6 |
Median BMI (Kg/m2) | 22.1 (20.4–23.6) | 21.1 (19.3–22.4) | 0.3 |
Lung stage‡ | |||
Forced expiratory volume (FEV) predicted | 50 (41–69) | 64 (48–83) | 0.2 |
Mild | 5 (26) | 10 (45) | 0.4 |
Moderate | 9 (47) | 8 (36) | |
Severe | 5 (26) | 4 (18) | |
Genotype§ | |||
ΔF508 homozygous | 9 (47) | 12 (55) | 0.5 |
ΔF508 heterozygous | 7 (37) | 6 (27) | 0.4 |
CF comorbidities | |||
Pancreatic insufficiency | 15 (79) | 21 (95) | 0.1 |
CF-related diabetes | 5 (26) | 7 (32) | 0.7 |
Liver disease | 6 (32) | 3 (14) | 0.2 |
Sinus disease | 5 (26) | 6 (27) | 0.9 |
Traditional cultured CF pathogens | |||
Pseudomonas aeruginosa | 19 (100) | 22 (100) | >0.99 |
Methicillin susceptible Staphylococcus aureus | 6 (32) | 2 (9) | 0.07 |
Methicillin resistant S. aureus | 0 | 0 | NA |
Other¶ | 2 (11) | 3 (14) | 0.8 |
X2 tests were used to determine differences between dichotomous clinical variables. Wilcoxon rank-sum tests were conducted for analysis of continuous variables.
*Response was a priori defined as achieving stable lung function as measured by FEV1 per cent predicted in the year following TIP/S initiation (no net decline).
†Non-R=non-responder.
‡Definitions of lung stage based on forced expiratory volume in one second; mild ≥70%, moderate ≥40 to <70%, severe <40%.
§Genotypic data were unknown for one patient in the non-responder group.
¶Other bacterial species include Escherichia coli, Enterobacter cloacae, Serratia marcescens, Streptococcus Group C, Stenotrophomonas maltophilia.
BMI, body mass index; CF, cystic fibrosis; NA, not applicable; TIP/S, tobramycin inhalational powder/solution.