Table 1 Details of the trials included
Study | Reference | Included in previous systematic review | Design | Patient age | Primary outcome |
|---|---|---|---|---|---|
LABA studies | |||||
Formoterol added to budesonide versus budesonide | |||||
SD-039-0719 NCT00646529 | Berger 2010 [32] | Yes (Chauhan) | 26-week, randomised, open-label, parallel-group, multicentre trial | 6–11 years | Safety |
SD-039-0725 NCT00646321 | Eid 2010 [33] | Yes (Chauhan) | 12-week, randomised, double-blind, parallel-group, multicentre trial | 6–15 years | PEF |
Study 0688 | Pohunek 2006 [34] | Yes (Chauhan) | 12-week, randomised, double-blind, parallel-group, multicentre trial | 4–11 years | Morning PEF |
SD-039-0714 ATTAIN | CSR 2003 [35] | Yes (Chauhan) | 12-week, randomised, double-blind, parallel-group, multicentre trial | 12–17 years | Morning PEF |
CHASE 3 NCT02091986 | Pearlman 2017 [29] | No | 12-week, randomised, double-blind, parallel-group, multicentre trial | 6–< 12 years | FEV1 |
Akpinarli 1999 [36] | Yes (Chauhan) | 6-week, randomised, double-blind, parallel-group, multicentre trial | 6–14 years | NR | |
SD-039-0718 NCT00651547 | Yes (Chauhan) | 12-week, randomised, double-blind, parallel-group, multicentre trial | 6–15 years | Morning PEF | |
SD-039-0682 | Morice 2008 [37] | Yes (Chauhan) | 12-week, randomised, double-blind, parallel-group, multicentre trial | 6–11 years | Morning PEF |
Salmeterol added to ICS versus ICS | |||||
SAS30031 | Malone 2005 [38] | Yes (Chauhan) | 12-week, randomised, double-blind, parallel-group, multicentre trial | 4–11 years | Safety |
Carroll 2010 [39] | Yes | 8-week, randomised, double-blind, parallel-group, single-centre study | 7–18 years | Salbutamol response following cold air challenge | |
MASCOT | Lenney 2013 [40] | Yes | 48-week, randomised, double-blind, parallel-group, multicentre trial | 6–14 years | Exacerbations |
Teper 2005 [41] | Yes (Chauhan) | 12-month, randomised, double-blind, parallel-group, single-centre trial | 6–14 years | NR | |
SFA100316 NCT00118690 | Murray 2011 [42] | Yes (Chauhan) | 4-week, randomised, double-blind, parallel-group, multicentre trial | 4–17 years | FEV1 following exercise |
SFA100314 | Pearlman 2009 [43] | Yes (Chauhan) | 4-week, randomised, double-blind, parallel-group, multicentre trial | 4–17 years | FEV1 following exercise |
Simons 1997 [44] | Yes (Chauhan) | 28-day, randomised, double-blind, crossover, single-centre trial | 12–18 years | NR | |
SAM40012a | Yes (Chauhan) | 6-month, randomised, double-blind, parallel-group, multicentre trial | 4–11 years | Symptom-free days/nights | |
SALMP/AH91/D89 | Russell 1995 [45] | Yes (Chauhan) | 12-week, randomised, double-blind, parallel-group, multicentre trial | 4–16 years | Morning PEF % predicted |
N/A | Langton Hewer 1995 [46] | Yes (Chauhan) | 8-week, randomised, double-blind, parallel-group, single-centre trial | 12–17 years | Not identified |
Verberne 1998 [47] | Yes (Chauhan) | 54-week, randomised, double-blind, parallel-group, multicentre trial | 6–16 years | FEV1 and response to methacholine | |
Meijer 1995 [48] | Yes (Chauhan) | 16-week, randomised, double-blind, parallel-group, single-centre trial | 7–15 years | NR | |
Vilanterol added to fluticasone propionate versus fluticasone propionate | |||||
NCT01573767 | Oliver 2016 [28] | No | 4-week, randomised, double-blind, parallel-group, multicentre trial | 5–11 years | Evening PEF |
Tiotropium studies | |||||
Tiotropium added to ICS versus ICS | |||||
RubaTinA-asthma® NCT01257230 2010–021093-11 | Hamelmann 2016 [11] | No | 48-week, randomised, double-blind, parallel-group, multicentre trial | 12–17 years | Peak FEV1 response |
CanoTinA-asthma® NCT01634139 2011–001758-26 | Vogelberg 2018 [31] | No | 48-week, randomised, double-blind, parallel-group, multicentre trial | 6–11 years | Peak FEV1 response |
PensieTinA-asthma® NCT01277523 2010–021778-13 | Hamelmann 2017 [14] | No | 12-week, randomised, double-blind, parallel-group, multicentre trial | 12–17 years | Peak FEV1 response |
VivaTinA-asthma® NCT01634152 2011–001777-43 | Szefler 2017 [13] | No | 12-week, randomised, double-blind, parallel-group, multicentre trial | 6–11 years | Peak FEV1 response |
Montelukast studies | |||||
Simons 2001 [49] | Yes (Castro-Rodriguez) | 12-week, randomised, double-blind, crossover, multicentre trial | 6–14 years | % change in FEV1 from baseline | |
Miraglia del Giudice 2007 [50] | Yes (Castro-Rodriguez) | 1-month, randomised, double-blind, crossover, single-centre study | 7–11 years | NR | |
Stelmach 2007 [51] | Yes (Zhao) | 4-week, randomised, double-blind, parallel-group, single-centre study | 6–18 years | 4 lung function parameters | |
NCT01266772 | Stelmach 2015 [30] | No | 7-month, randomised, double-blind, parallel-group, single-centre study | 6–14 years | NR |