Shionogi, phase II [29] | Pirfenidone versus placebo | Hugh–Jones | Tertiary | ns | No difference in worsening of HRQoL |
CRQ | ns |
IFIGENIA phase III, NCT00639496; 2008 [30] | N-acetylcysteine versus placebo | SGRQ | Secondary | ns | No significant change in HRQoL |
Etanercept phase II, NCT00063869; 2003 [31] | Etanercept versus placebo | SGRQ | Secondary | p<0.001 | Significant decline in HRQoL in both arms |
SF-36 | SF-36 physical p<0.001, mental p=0.09 |
MDI |
MDI NR |
INSPIRE phase II, NCT00075998; 2004 [32] | IFN-γ versus placebo | SGRQ | Secondary | ns | No difference in worsening of HRQoL and dyspnoea |
UCSD-SOBQ | ns |
STEP-IPF phase III, NCT00517933; 2007 [33] | Sildenafil versus placebo | SGRQ | Secondary | p=0.01 | Significant difference in HRQoL and dyspnoea favouring sildenafil |
UCSD- |
SOBQ | p=0.006 |
Borg | ns |
SF-36 | p=0.008 |
EQ-5D | ns |
BUILD-3 phase III, NCT00391443; 2006 [34] | Bosentan versus placebo | SF-36 | Secondary | ns | No differences in worsening of HRQoL and dyspnoea |
EQ-5D | ns |
TDI | ns |
CAPACITY 1 and 2 phase III, NCT00287716; 2006 [35] | Pirfenidone versus placebo | UCSD-SOBQ | Secondary | ns | Nonsignificant worsening in dyspnoea in both arms |
BIBF-1120 phase II, NCT00514683; 2007 [36] | Nintedanib versus placebo | SGRQ | Secondary | p=0.007 | Statistically significant improvement in HRQoL not meeting clinical significance |
Ambrisentan phase II, NCT00768300; 2008 [37] | Ambrisentan versus placebo | SGRQ | Secondary | ns | No difference in worsening of HRQoL and dyspnoea between the two arms |
TDI | ns |
SF-36 | ns |
ASCEND phase III, NCT01366209; 2011 [38] | Pirfenidone versus placebo | UCSD-SOBQ | Secondary | ns | No difference in worsening dyspnoea between the two arms |
PANTHER, NCT00650091; 2008 [39] | N-acetylcysteine, azathioprine, prednisone versus placebo | SF-36 | Secondary | p=0.03 | No difference in worsening HRQoL and dyspnoea between the arms |
EQ-5D | ns |
SGRQ | ns |
UCSD-SOBQ ICE-CAP | ns p=0.01 |
INPULSIS phase III, NCT01335464, NCT01335477; 2011 [40] | Nintedanib | SGRQ | Secondary | INPULSIS 1 ns INPULSIS 2 p=0.02 CASA-Q NR | No difference in worsening HRQoL in pooled data versus placebo |
CASA-Q |
AmbOx phase IV, NCT02286063; 2014 [41] | Oxygen | K-BILD | Primary | p<0.0001 | Statistically significant improvement in HRQoL and dyspnoea with ambulatory oxygen use in patients with ILD with isolated exertional hypoxia. Did not meet minimum clinical significance |
UCSD-SOBQ | Secondary | p<0.0001 |
SGRQ | Secondary | p=0.018 |
HADS | Secondary | ns |
INSTAGE phase III, NCT02802345; 2016 [42] | Nintedanib Sildenafil | SGRQ | Primary | ns | No difference in change from baseline in the total score (worsening) on the SGRQ at week 12. No difference in worsening of dyspnoea from baseline between the two arms |
UCSD-SOBQ | Secondary | ns |
INBUILD phase III, NCT02999178; 2016 [43] | Nintedanib | K-BILD | Secondary | ns | No difference in worsening of HRQoL between the two arms |
Unclassifiable FILD phase II, NCT03099187; 2017 [44] | Pirfenidone | UCSD-SOBQ | Secondary | ns | No difference in worsening of HRQoL and symptoms between arms |
LCQ | ns |
Cough VAS | ns |
SGRQ | ns |
Advanced IPF phase II B,
NCT02951429;
2016 [45] | Pirfenidone,
sildenafil | SGRQ UCSD-SOBQ | Secondary
Secondary | ns
ns | No difference in worsening of HRQoL and dyspnoea between the two arms |