Use of Health Related Quality of Life in Clinical Trials for Severe Asthma: A Systematic Review

Figures & data

Figure 1 Search results and study selection.

Table 1 Included Papers and Corresponding Studies in Alphabetical Order

Included Papers (n= 58)	Study Reported (52 Studies)
Austin, 2020^Citation36	CLAVIER; NCT02099656
Ayars, 2013^Citation37	Nair, 2009; NCT00292877
Ayres, 2004^Citation38	Ayers, 2004
Bel, 2014^Citation39	SIRIUS; NCT01691508
Bernstein, 2020^Citation40	Bernstein, 2020; NCT02452190; NCT02501629
Bjermer, 2016^Citation41	Bjermer, 2016; NCT01270464
Bleecker, 2016^Citation42	SIROCCO; NCT01928771
Bousquet, 2011^Citation43	Bousquet, 2011
Brightling, 2015^Citation44	Brightling, 2015; NCT01402986
Brightling, 2020^Citation45	Luster 1 and 2; NCT02555683; NCT02563067
Buhl, 2002^Citation46	Soler, 2001
Buhl, 2002^Citation47	Soler, 2001
Busse, 2001^Citation48	Busse, 2001
Busse, 2019^Citation49	BORA; NCT02258542
Busse, 2019^Citation50	TROPOS; NCT02281357
Castro, 2010^Citation51	AIR 2; NCT00231114
Castro, 2011^Citation52	Castro, 2011
Castro, 2014^Citation53	Castro, 2014; NCT01238861
Castro, 2015^Citation54	Castro, 2015; NCT01287039; NCT01285323;
Chanez, 2010^Citation55	Chanez, 2010; NCT00454051
Chupp, 2017^Citation56	MUSCA; NCT02281318
Corren, 2011^Citation57	MILLY; NCT00930163
Corren, 2016^Citation58	Corrren, 2016; NCT01508936
Corren, 2017^Citation59	Corren, 2017; NCT02054130
Cox, 2007^Citation60	AIR 1; NCT00214526
Finn, 2003^Citation61	Busse, 2001
FitzGerald, 2016^Citation62	CALIMA; NCT01914757
Garcia, 2013^Citation63	Garcia, 2013; NCT01007149
Gonem, 2016^Citation64	Gonem, 2016; NCT01545726
Goorsenberg & Hooghe, 2020^Citation65	TASMA; NCT02225392
Gottlow, 2019^Citation66	STRATOS 1 and 2; NCT02161757; NCT02194699
Haldar, 2009^Citation67	Haldar, 2009; ISRCTN75169762
Hall, 2020^Citation68	Hall, 2020; NCT01832363
Hanania, 2011^Citation69	EXTRA; NCT00314574 (corrected number)
Holgate, 2004^Citation70	Holgate, 2004
Hoshino, 2012^Citation71	Hoshino, 2012
Humbert, 2005^Citation72	INNOVATE
Lanier, 2003^Citation73	Lanier, 2003
Ledford, 2017^Citation74	XPORT; NCT01125748
Li, 2016^Citation75	Li, 2016; NCT01202903
Mukherjee, 2019^Citation76	Mukherjee, 2019; NCT02049294
Nair, 2017^Citation77	ZONDA; NCT02075255
Ohta, 2009^Citation78	Ohta, 2009
Ohta, 2018^Citation79	CALIMA; NCT01914757
Ortega, 2014^Citation80	MENSA; NCT01691521
Panettieri, 2018^Citation81	STRATOS 1 and 2; NCT02161757; NCT02194699;
Panettieri, 2020^Citation82	SOLANA; NCT02869438
Pasha, 2014^Citation83	Pasha, 2014; NCT00139152
Pavord, 2007^Citation84	RISA; NCT00214539
Pavord, 2012^Citation85	DREAM; NCT01000506
Piper, 2013^Citation86	Piper, 2013; NCT00873860
Rubin, 2012^Citation87	QUALITX
Russell, 2018^Citation88	MESOS; NCT02449473
Sakamoto, 2020^Citation89	Sakamoto, 2020; NCT01913028
Soler, 2001^Citation90	Soler, 2001
Sthoeger, 2007^Citation91	INNOVATE
Vignola, 2004^Citation92	SOLAR
Zeitlin, 2018^Citation93	ALIZE; NCT02814643

Table 2 Characteristics of Included Studies (N= 52)

Severe Asthma Treatment Trialled	n (%)
Omalizumb	18 (35)
Benralizumab	7 (14)
Mepolizumab	6 (12)
Tralokinumab	5 (10)
Reslizumab	5 (10)
Bronchial Thermoplasty	5 (10)
Lebrikuzumab	2 (4)
Tezepelumab	2 (4)
Fevipiprant	2 (4)
Year published
2001–2005	7 (14)
2006–2010	7 (14)
2011–2015	14 (27)
2016–2020	24 (46)

Figure 2 Number and proportion (%) of studies reporting of asthma HRQoL questionnaires and where this data is reported.

Table 3 Number and Proportion (%) of the Specific HRQoL Measures Used by Studies That Included a Measure of HRQoL

	2001–2005 (n= 5)	2006–2010 (n= 4)	2011–2015 (n= 8)	2016–2020 (n= 16)
SGRQa	0	0	2 (25%)	2 (12.5)
AQLQb	5 (100)	4 (100)	3 (38)	3 (19)
AQLQ(S)c	0	0	3 (38)	3 (19)
AQLQ +12d	N/A	0	0	8 (50)

Note: Year validated: _a1992, _b1993, _c1999, _d2005.

Austin CD, Gonzalez Edick M, Ferrando RE, et al. A randomized, placebo‐controlled trial evaluating effects of lebrikizumab on airway eosinophilic inflammation and remodelling in uncontrolled asthma (CLAVIER). Clin Exp Allergy. 2020;50:1342–1351. doi:10.1111/cea.13731

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