Primary and secondary efficacy endpoint analysis: change between PSALTI and control groups at baseline to 4 weeks and at 4 weeks to 3 month follow-up
| Between-group difference Baseline to 4 weeks | Between-group difference 4 weeks to 3-month follow-up | |||
|---|---|---|---|---|
| Mean difference (95% CI) | p Value | Mean difference (95% CI) | p Value | |
| LCQ total | 1.53 (0.21 to 2.85) | 0.024* | 0.01 (−1.62 to 1.64) | 0.994 |
| CFper hour (fold change) | 0.59 (0.36 to 0.95) | 0.030* | 1.01 (0.55 to 1.86) | 0.966 |
| VAS severity | −9.72 (−20.80 to 1.36) | 0.084 | 1.6 (−15.48 to 18.74) | 0.848 |
| SF-36 PCS | 0.56 (−2.52 to 3.64) | 0.717 | 0.48 (−3.27 to 3.37) | 0.977 |
| SF-36 MCS | 0.81 (−3.10 to 4.72) | 0.680 | 0.72 (−3.06 to 4.51) | 0.703 |
| VPQ | 3.90 (−0.33 to 8.12) | 0.070 | −0.20 (−3.43 to 3.03) | 0.901 |
| HADS—Anxiety | −0.42 (−1.96 to 1.13) | 0.590 | 0.88 (−0.57 to 2.34) | 0.225 |
| HADS—Depression | −0.44 (−1.69 to 0.81) | 0.486 | −0.18 (−1.36 to 0.99) | 0.753 |
| C2 (fold change) | 1.11 (0.76 to 1.61) | 0.575 | NA | NA |
| C5 (fold change) | 1.11 (0.80 to 1.54) | 0.512 | NA | NA |
Between-group differences were calculated using ANCOVA adjusted for baseline values.
Positive change in LCQ, SF-36 PCS and SF-36 MCS indicates improvement in symptoms. Negative change in VAS, VPQ, HADS indicates improvement in symptoms. Fold change: 0–1 is a reduction and ≥1 is an increase in outcome measure.
*p<0.05.
ANCOVA, analysis of covariance; C2, concentration of capsaicin that caused ≥2 coughs; C5, concentration of capsaicin that caused ≥5 coughs; CFper hour, cough frequency per hour over a 24-hour period; HADS, Hospital Anxiety and Depression Scale; LCQ, Leicester Cough Questionnaire; MCS, mental component score; NA, not assessed at this time point; PCS, physical component score; PSALTI, physiotherapy, and speech and language therapy intervention; SF-36, short form 36 questionnaire; VAS, visual analogue scale; VPQ, vocal performance questionnaire.