Primary and second efficacy endpoints: within-group change
| Change from baseline to 4 weeks | Change from 4 weeks to 3-month follow-up | |||||||
|---|---|---|---|---|---|---|---|---|
| PSALTI Mean difference (95% CI) | p Value | Control Mean difference (95% CI) | p Value | PSALTI Mean difference (95% CI) | p Value | Control Mean difference (95% CI) | p Value | |
| LCQ total mean | 3.40 (2.26 to 4.55) | <0.001* | 1.66 (0.78 to 2.54) | <0.001* | −0.17 (−1.49 to 1.15) | 0.794 | 0.27 (−0.82 to 1.35) | 0.616 |
| CFper hour (fold change) | 0.55 (0.33 to 0.75) | 0.002* | 0.82 (0.60 to 1.22) | 0.205 | 1.26 (0.84 to 1.90) | 0.236 | 0.91 (0.59 to 1.39) | 0.655 |
| VAS severity | −21.18 (−29.83 to −12.53) | <0.001* | −11.84 (−20.11 to −3.57) | 0.007* | 9.74 (−3.60 to 23.08) | 0.143 | 0.79 (−10.73 to 12.31) | 0.888 |
| C2 (fold change) | 1.28 (0.96 to 1.71) | 0.089 | 1.06 (0.81 to 1.36) | 0.666 | NA | NA | NA | NA |
| C5 (fold change) | 1.24 (1.02 to 1.50) | 0.035* | 1.08 (0.87 to 1.36) | 0.469 | NA | NA | NA | NA |
| SF-36 PCS | 1.62 (−0.96 to 4.21) | 0.208 | 0.50 (−1.30 to 2.31) | 0.574 | 0.54 (−1.82 to 2.89) | 0.639 | 0.76 (−1.66 to 3.18) | 0.522 |
| SF-36 MCS | 0.53 (−2.69 to 3.75) | 0.736 | −0.26 (−2.92 to 2.40) | 0.843 | 1.09 (−1.91 to 4.09) | 0.456 | 0.49 (−2.35 to 3.32) | 0.727 |
| VPQ | 4.04 (0.12 to 7.97) | 0.044* | 0.73 (−1.94 to 3.39) | 0.582 | −1.63 (−4.17 to 0.91) | 0.193 | −0.57 (−3.29 to 2.15) | 0.666 |
| HADS—Anxiety | −1.27 (−2.51 to −0.032) | 0.045* | −0.90 (−1.96 to 0.17) | 0.095 | −0.11 (−1.16 to 0.94) | 0.826 | 0.95 (−0.22 to 2.11) | 0.104 |
| HADS—Depression | −0.68 (−1.57 to 0.21) | 0.126 | −0.21 (−1.11 to 0.69) | 0.641 | 0.06 (−1.42 to 1.53) | 0.937 | 0.05 (−0.66 to 0.76) | 0.878 |
Positive change in LCQ, SF-36 PCS and SF-36 MCS indicates improvement in symptoms. Negative change in VAS, VPQ and HADS indicates improvement in symptoms. Fold change: 0-1 is a reduction and ≥1 is an increase in outcome measure.
*p<0.05
C2, capsaicin cough challenge––concentration that resulted in two or more coughs; C5, capsaicin cough challenge—concentration that resulted in five or more coughs; CFper hour, cough frequency per hour over a 24-hour period; HADS, Hospital Anxiety and Depression Scale; LCQ, Leicester Cough Questionnaire; NA, not assessed at this time point; PCS, physical component score; PSALTI, physiotherapy, and speech and language therapy intervention; SF-36 MCS, mental component score; SF-36, short form 36 questionnaire; VAS, visual analogue scale; VPQ, vocal performance questionnaire.