Table 2. Baseline characteristics.
| Total population (n = 21) | Effectiveness analyses (n = 12) | |
|---|---|---|
| Gender, n (%) | ||
| Male | 13 (61.9) | 8 (66.7) |
| Female | 8 (38.1) | 4 (33.3) |
| Age in years, mean (range) | 29.2 (18.0–50.0) | 32.8 (18.5–50.0) |
| BMI, mean (range) | 21.0 (16.2–31.1) | 22.3 (19.6–31.1) |
| CFTR mutation, n (%) | ||
| Homozygote Phe508del | 13 (61.9) | 7 (58.3) |
| Heterozygote Phe508del | 7 (33.3) | 4 (33.3) |
| Other | 1 (4.8) | 1 (8.3) |
| Comorbidities, n (%) | ||
| Cystic fibrosis-related | 7 (33.3) | 5 (41.7) |
| diabetes (CFRD) | ||
| Cystic fibrosis-related liver | 8 (38.1) | 6 (50.0) |
| disease (CFLD) | ||
| Pancreas insufficiency | 19 (90.5) | 11 (91.7) |
| Osteoporosis | 6 (28.6) | 2 (16.7) |
| Forced Expiratory Volume in one second | ||
| Percentage of predicted, | 52.6 (23–86, ±20.8) | 54.6 (23–82, ±19.7) |
| mean (range, ±SD) | ||
| Absolute, mean (range, ±SD) | 1.99 (0.78–3.1, ±0.8) | 2.03 (0.89–3.1, ±0.74) |
| Azithromycin use | 20 (95.2) | 12 (100.0) |
| Duration Colistin nebulization | ||
| Days (range, ±SD) | 1508 (562–1827, ±2504.2) | |
| Years (range, ±SD) | 4.1 (1.5–5.0, ±1.4) | |
| Duration Twincer | ||
| Days (range, ±SD) | 610 (199–1055, ±302.1) | |
| Years (range, ±SD) | 1.7 (0.6–2.9, ±0.8) | |
| Mean no. of IVAB courses | ||
| Nebulisation (range, ±SD) | 1.51 (0–3.81, ±1.35) | |
| Twincer (range, ±SD) | 1.67 (0–3.48, ±1.55) | |
| Mean no. of all AB courses | ||
| Nebulisation (range, ±SD) | 2.70 (0–8.37, ±2.34) | |
| Twincer (range, ±SD) | 2.28 (0–6.15, ±1.93) |
The data of twelve of the twenty-one patients could be used for effectiveness analyses, as these patients used nebulization therapy >1 year before start with the Twincer (nine patients used colistin nebulizations, one used tobramycin nebulizations, and 2 patients used alternating colistin and tobramycin nebulizations). The other nine patients could not be used for the effectiveness analyses for the following reasons: five patients (23.8%) discontinued the Twincer within two months of commencement, two patients (9.5%) used DPI tobramycin before switching to the Twincer, one patient (4.8%) did not have inhalation therapy before initiation with the Twincer and one patient (4.8%) started with colistin as treatment for an Achromobacter species infection.