Table 4

Primary and second efficacy endpoints: within-group change

 Change from baseline to 4 weeksChange from 4 weeks to 3-month follow-up
PSALTI
Mean difference (95% CI)
p ValueControl
Mean difference (95% CI)
p ValuePSALTI
Mean difference (95% CI)
p ValueControl
Mean difference (95% CI)
p Value
LCQ total mean3.40 (2.26 to 4.55)<0.001*1.66 (0.78 to 2.54)<0.001*−0.17 (−1.49 to 1.15)0.7940.27 (−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)0.2051.26 (0.84 to 1.90)0.2360.91 (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)0.1430.79 (−10.73 to 12.31)0.888
C2 (fold change)1.28 (0.96 to 1.71)0.0891.06 (0.81 to 1.36)0.666NANANANA
C5 (fold change)1.24 (1.02 to 1.50)0.035*1.08 (0.87 to 1.36)0.469NANANANA
SF-36 PCS1.62 (−0.96 to 4.21)0.2080.50 (−1.30 to 2.31)0.5740.54 (−1.82 to 2.89)0.6390.76 (−1.66 to 3.18)0.522
SF-36 MCS0.53 (−2.69 to 3.75)0.736−0.26 (−2.92 to 2.40)0.8431.09 (−1.91 to 4.09)0.4560.49 (−2.35 to 3.32)0.727
VPQ4.04 (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)0.8260.95 (−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)0.6410.06 (−1.42 to 1.53)0.9370.05 (−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.