Treatment effects in the two groups
| Amoxicillin/clavulanic acid (N=18) | Placebo (N=17) | p Value | |
|---|---|---|---|
| Resolution of AECOPD within 28 days (number (%)) | 15 (83) | 14 (82) | 1.00 |
| Daily AECOPD severity score (median (range)) | 5.7 (4.3–7.8) | 5.4 (2.4–8.4) | 0.70 |
| Number of AECOPD days with a severity score >6 (median (range)) | 3 (0–25) | 3 (0–24) | 0.68 |
| Relapse within 28 days (Number (%)) | 2 (11) | 1 (6) | 1.0 |
| Number of AECOPDs within 4 months after end of study (number (%)) | 0.66 | ||
| 0 | 7 (39) | 10 (59) | |
| 1 | 6 (33) | 4 (24) | |
| 2 | 4 (22) | 3 (18) | |
| 3 | 1 (16) | 0 (0) | |
| Change in CCQ scores from inclusion to day 28 (mean (SD)) | |||
| Total | −2.3 (2.7) | −2.3 (2.7) | 0.88 |
| Mental state | −0.6 (1.5) | −0.3 (1.3) | 0.55 |
| Functional state | −0.6 (1.0) | −0.8 (1.0) | 0.72 |
| Symptom | −1.2 (1.4) | −1.2 (1.4) | 0.92 |
| Change in CRQ scores from inclusion to day 28 (mean (SD)) | |||
| Dyspnoea | 0.5 (1.3) | 0.5 (1.6) | 0.91 |
| Fatigue | 1.2 (1.2) | 0.4 (1.3) | 0.07 |
| Emotional function | 0.1 (0.9) | 0.6 (1.2) | 0.23 |
| Mastery | 0.3 (1.4) | 0.4 (1.4) | 0.94 |
| Change in lung function postbronchodilation from inclusion to day 28 (mean (SD)) | |||
| FEV1 in litres | 0.02 (0.21) | 0.07 (0.27) | 0.51 |
| FEV1% predicted | 1.6 (8.8) | 2.4 (8.9) | 0.80 |
| Change in sputum colour from inclusion to day 28 (mean (SD))* | −0.46 (1.1) | 0.2 (2.7) | 0.39 |
| Change in sputum purulence from inclusion to day 28 (number (%)) | 0.57 | ||
| Mucoid to mucoid | 1 (6) | 2 (12) | |
| Mucoid to purulent | 0 | 2 (12) | |
| Purulent to purulent | 11 (61) | 8 (47) | |
| Purulent to mucoid | 6 (33) | 5 (29) | |
| Procalcitonin level (µg/L) (median (range)) | 0.06 (0.03–0.26) | 0.05 (0.03–0.24) | 0.28 |
| Procalcitonin cut-off level (number (%)) | 0.48 | ||
| <0.1 µg/L | 15 (83) | 16 (94) | |
| 0.1–0.25 µg/L | 2 (11) | 1 (6) | |
| >0.25 µg/L | 1 (6) | 0 | |
To identify treatment effects that differed between the treatment groups, t tests in case of normally distributed variables were performed. For not normally distributed variables this was performed by Mann-Whitney U test. Between-group comparisons of categorical variables were performed by χ2 tests or Fisher's Exact tests as appropriate.
*Score according to the Stockley protocol with the nine-point colour chart (BronkoTest, Heredilab Inc, Salt Lake City, Utah, USA).
AECOPD, acute Exacerbation in COPD; CCQ, Clinical COPD Questionnaire; CRQ, Chronic Respiratory Questionnaire.