Table 2.
Mean change from baseline to outcome, and difference between treatment groups in mean change, in study endpoints after 8 weeks of treatment with AKL1 or placebo
| AKL1 (N=20)
|
Placebo (N=13)
|
Difference in mean change (95% CI) | P-valuea | |||
|---|---|---|---|---|---|---|
| n | Mean (SD) | n | Mean (SD) | |||
| Spirometry, postbronchodilator | ||||||
| FEV1 (L) | 16 | −0.1 (0.2) | 11 | −0.2 (0.2) | 0.09 (−0.07 to 0.25) | 0.27 |
| FEV1 (%predicted) | 17 | −5.4 (13.5) | 12 | −5.0 (7.1) | −0.4 (−9.2 to 8.4) | 0.92 |
| 6-minute walk distance (m) | 19 | −5.5 (61.4) | 13 | −13 (64.5) | 7 (−39 to 54) | 0.74 |
| LCQ score | 19 | 2.3 (4.9) | 13 | 0.6 (3.7) | 1.8 (−1.5 to 5.1) | 0.28 |
| SGRQ total score, units | 13 | −7.7 (11.7) | 9 | 1.5 (9.3) | −9.2 (−19.0 to 0.6) | 0.064 |
| SGRQ – symptoms domain | −6.2 (14.6) | 2.2 (14.5) | −8.5 (−19.3 to 2.4) | |||
| SGRQ – activity domain | −10.0 (17.0) | 1.6 (10.4) | −11.6 (−26.2 to 3.0) | |||
| SGRQ – impact domain | −4.9 (11.7) | 3.5 (11.5) | −8.4 (−18.5 to 1.8) | |||
| CCQ score | 19 | −0.01 (0.6) | 13 | 0.1 (0.7) | −0.07 (−0.5 to 0.4) | 0.76 |
| Modified MRC dyspnea score | 17 | −0.2 (0.8) | 12 | −0.2 (0.6) | not applicable | 0.23 |
Notes: The minimal clinically important differences are as follows: 1.3 for the LCQ (higher score is better);24 4.0 for the SGRQ (lower is better);26 and 0.4 for the CCQ (lower is better).27
Student’s t-test for FEV1 and FEV1 %predicted, 6-minute walk distance, CCQ, LCQ, and SGRQ, and χ2 test for the MRC comparing the two treatment groups for change from baseline to outcome. AKL1: AKL International, Ltd, Guernsey, UK.
Abbreviations: CCQ, Clinical COPD Questionnaire; CI, confidence interval; FEV1, forced expiratory volume in 1 sec; LCQ, Leicester Cough Questionnaire; MRC, Medical Research Council; SD, standard deviation; SGRQ, St George’s Respiratory Questionnaire.