Parameter | FCM (n=24) | Placebo (n=24) | Mean treatment effect of FCM (95% CI) | P value | ||||
Baseline | Week 1 | Week 8 | Baseline | Week 1 | Week 8 | |||
Oxygenation | ||||||||
Resting SpO2, % | 94.1±2.3 | 94.5±1.9 | 93.7±2.3 | 94.7±1.6 | 94.4±2.0 | 94.9±1.7 | 0.03 (−0.6 to 0.7) | 0.93 |
Mean nocturnal SpO2, % | 91.8±2.3a | 92.3±1.9a | 92.0±2.1a | 92.0±2.2b | 92.3±2.1b | 92.2±2.5b | 0.4 (−0.3 to 1.0) | 0.32 |
Nocturnal SpO2 <90%, % | 14.7±24.2a | 14.6±18.8a | 13.8±21.1a | 16.4±25.6b | 15.5±23.8b | 15.8±24.6b | −0.3 (−8.1 to 7.6) | 0.94 |
Oxygen desaturation index, per hour | 8.0±9.2a | 7.3±10.6a | 7.8±13.2a | 6.4±5.5b | 6.7±5.7b | 7.5±5.1b | −0.8 (−3.5 to 1.9) | 0.56 |
Capillary PO2, kPa | 9.35±1.13b | 9.14±1.23b | 9.19±1.07b | 9.37±1.19a | 9.27±1.11a | 9.04±0.83a | −0.11 (−0.45 to 0.23) | 0.52 |
Capillary SO2, % | 94.6±2.0b | 94.4±1.9b | 94.4±1.6b | 94.6±2.1a | 94.4±1.6a | 94.1±1.6a | −0.1 (−0.7 to 0.4) | 0.64 |
6 min walk test | ||||||||
Distance, m | 330±89 | 343±93 | 354±92 | 335±92b | 337±101b | 345±104b | 12.6 (1.6 to 23.5) | 0.02 |
SpO2 change, % | −4.1±3.9 | −4.1±3.8 | −4.3±5.0 | −5.6±6.3b | −5.0±5.7b | −5.2±6.6b | −0.1 (−1.7 to 1.5) | 0.91 |
Heart rate change, per minute | 18.4±16.8 | 14.0±15.8 | 19.3±17.6 | 17.7±14.3b | 18.1±16.3b | 17.5±17.8b | −2.5 (−9.8 to 4.9) | 0.50 |
Symptom and quality of life scores* | ||||||||
BODE score | 3.5±2.1a | 3.3±2.1a | 3.4±2.1a | 3.5±2.0c | 3.5±2.0c | 3.5±1.9c | −0.2 (−0.6 to 0.1) | 0.22 |
COPD Assessment Test | 14.5±6.3 | 14.8±7.8 | 16.6±7.3 | 16.5±7.1 | 15.5±8.0 | 18.3±7.5 | 0.03 (−1.6 to 1.6) | 0.97 |
St George’s Respiratory Questionnaire total score | 41.8±15.6 | 39.8±15.7 | 41.5±15.3 | 46.1±17.2 | 44.9±18.0 | 47.9±18.0 | −2.3 (−4.8 to 0.1) | 0.06 |
Modified MRC Dyspnoea Scale | 1.9±0.9 | 1.5±0.8 | 1.8±1.0 | 2.0±1.1 | 2.0±0.9 | 2.0±1.1 | −0.4 (−0.7 to −0.1) | 0.008 |
Dyspnoea-12 Score | 9.0±7.0 | 9.5±8.0 | 10.9±7.7 | 10.1±7.4 | 10.5±8.3 | 11.1±7.8 | 0.6 (−0.9 to 2.1) | 0.43 |
Fatigue Severity Scale | 33.0±15.7 | 31.0±13.7 | 32.0±12.6 | 39.8±16.0 | 37.6±16.8 | 41.1±15.2 | −2.5 (−5.7 to 0.7) | 0.13 |
Hospital Anxiety and Depression Scale-anxiety score | 4.3±4.1 | 4.7±4.2 | 4.5±4.6 | 5.4±4.1 | 5.3±4.1 | 5.1±4.0 | 0.5 (−0.4 to 1.3) | 0.31 |
Hospital Anxiety and Depression Scale-depression score | 4.2±2.4 | 4.2±2.8 | 3.8±2.5 | 5.9±3.7 | 5.8±3.5 | 5.7±3.3 | −0.1 (−0.7 to 0.6) | 0.89 |
Visual Analogue Scales | ||||||||
Dyspnoea | 28.3±19.9 | 32.1±25.0 | 27.6±21.5 | 32.4±23.9 | 39.7±25.2 | 33.8±23.9 | 2.9 (−6.9 to 12.6) | 0.56 |
Cough | 28.6±25.4 | 34.4±26.5 | 34.6±27.5 | 31.3±28.0 | 30.6±26.0 | 29.9±22.7 | 6.1 (−4.3 to 16.5) | 0.25 |
Sputum production | 24.9±26.1 | 21.4±20.1 | 27.5±24.0 | 21.2±22.8 | 24.9±23.7 | 25.6±20.0 | −2.6 (−10.1 to 4.8) | 0.48 |
Sputum purulence | 18.9±20.8c | 17.1±19.4c | 17.7±21.4c | 24.4±27.0c | 19.6±19.4c | 26.0±20.7c | −2.9 (−10.2 to 4.4) | 0.43 |
Spirometry | ||||||||
FEV1, L | 1.08±0.46a | 1.04±0.44a | 1.07±0.44a | 1.25±0.34 | 1.27±0.39 | 1.27±0.38 | −0.03 (−0.08 to 0.01) | 0.12 |
FEV1, % of predicted | 43.6±16.0a | 42.3±15.2a | 43.1±14.5a | 46.0±15.2 | 46.3±16.0 | 46.5±16.5 | −1.3 (−3.0 to 0.4) | 0.13 |
FEV1/FVC, % | 40.4±10.7a | 41.3±10.7a | 41.0±10.0a | 39.8±10.9 | 39.2±11.1 | 39.3±10.4 | 1.1 (−0.8 to 3.0) | 0.24 |
Echocardiography | ||||||||
Tricuspid regurgitant jet measured, n (%) | 8 (33.3) | 8 (33.3) | 6 (25.0) | 7 (29.2) | 7 (29.2) | 6 (25.0) | – | – |
Trans-tricuspid pressure gradient, mm Hg | 28.8±4.5d | 26.8±2.7d | 28.2±2.4d | 35.2±7.3d | 35.8±7.6d | 36.9±12.4d | −2.4 (−5.2 to 0.4) | 0.09 |
All data are reported as mean±SD.
Statistical analysis was performed by linear mixed effects modelling.
P values and mean treatment effect are given for the fixed effect of ‘status post FCM infusion’.
Descriptive data (mean±SD) are reported for participants with a valid measurement at each time point (an=23, bn=22, cn=21, dn=6); cases with partially missing data were excluded. Cases with missing data were still included in the linear mixed effects model.
*Scale ranges: BODE 0–10, COPD Assessment Test 0–40, Dyspnoea-12 Score 0–36, Fatigue Severity Scale 9–63, Hospital Anxiety and Depression Scale 0–21, Likert scale 1–7, modified MRC scale 0–4, St George’s Respiratory Questionnaire 0–100, Visual Analogue Scales 0–100. For all scores a lower value is better.
COPD, chronic obstructive pulmonary disease; FCM, ferric carboxymaltose; FEV1, forced expiratory volume in 1 s; FVC, forced vital capacity; MRC, Medical Research Council; PO2, Partial pressure of oxygen; SO2, Oxygen saturation; SpO2, peripheral oxygen saturation.