A comparison of tiotropium, long-acting β2-agonists and leukotriene receptor antagonists on lung function and exacerbations in paediatric patients with asthma

Vogelberg, Christian; Goldstein, Stanley; Graham, LeRoy; Kaplan, Alan; de la Hoz, Alberto; Hamelmann, Eckard

doi:10.1186/s12931-020-1282-9

Table 3 Mean difference in FEV₁% predicted

From: A comparison of tiotropium, long-acting β₂-agonists and leukotriene receptor antagonists on lung function and exacerbations in paediatric patients with asthma

Drug	Age, years	n^a	Mean difference FEV₁, % predicted (95% CI) active drug vs placebo
LABA added to ICS versus ICS, FEV₁ response (Cochrane analysis: Chauhan 2015)		534	2.99 (0.86, 5.11)^b
Formoterol added to ICS versus ICS
Akpinarli 1999 Formoterol 12 μg BID add-on to ICS 400–800 μg/day	6–14	32	2.00 (−24.10, 28.10)^b
Salmeterol added to beclomethasone dipropionate versus beclomethasone dipropionate
Verberne 1998 Salmeterol/beclomethasone dipropionate 50/200 μg BID vs beclomethasone dipropionate 200 μg BID	6–16	117	3.08 (−0.49, 6.65)^b
Meijer 1995 Salmeterol 50 μg BID + beclomethasone dipropionate 250 μg BID	7–15	39	3.60 (−2.94, 10.14)^b
Salmeterol added to fluticasone propionate versus fluticasone propionate
Carroll 2010 Fluticasone/salmeterol 100/50 BID vs fluticasone 100 μg BID	7–18	37	5.20 (−1.04, 11.44)^b
Lenney 2013 Fluticasone propionate/salmeterol 100/50 μg BID vs fluticasone propionate 100 μg BID	6–14	21	15.42 (1.51, 29.33)^b
Teper 2005 Fluticasone/salmeterol 125/25 μg BID vs fluticasone 125 μg BID	6–14	82	−0.40 (−5.03, 4.23)^b
Salmeterol added to ICS versus ICS
Russell 1995 Salmeterol 50 μg BID add-on to ICS 400–2400 μg/day	4–16	206	3.40 (−1.54, 8.34)^b
Tiotropium in moderate asthma
Tiotropium 5 μg Add-on to 400–800 μg/day budesonide (200–800 μg/day for patients aged 12–14 years)	12–17	268 268	Trough: 3.205 (0.209, 6.201) Peak: 4.492 (1.700, 7.285)
Tiotropium 2.5 μg Add-on to 400–800 μg/day budesonide (200–800 μg/day for patients aged 12–14 years)	12–17	256 257	Trough: 2.850 (−0.229, 5.929) Peak: 4.066 (1.208, 6.924)
Tiotropium 5 μg Add-on to 200–400 μg budesonide	6–11	260 260	Trough: 4.439 (1.207, 7.671) Peak: 6.521 (3.717, 9.325)
Tiotropium 2.5 μg Add-on to 200–400 μg budesonide	6–11	257 257	Trough: 5.048 (1.811, 8.285) Peak: 7.698 (4.892, 10.505)
Tiotropium in severe asthma
Tiotropium 5 μg Add-on to high-dose ICS^c + ≥1 controller or medium-dose ICS^d + ≥2 controllers	12–17	262 262	Trough: 0.827 (−2.354, 4.008) Peak: 1.643 (−1.252, 4.539)
Tiotropium 2.5 μg Add-on to high-dose ICS^c + ≥1 controller or medium-dose ICS^d + ≥2 controllers	12–17	258 258	Trough: 3.283 (0.075, 6.491) Peak: 3.106 (0.188, 6.024)
Tiotropium 5 μg Add-on to > 400 μg budesonide + ≥1 controller or 200–400 μg budesonide + ≥2 controllers	6–11	258 258	Trough: 3.848 (0.576, 7.120) Peak: 6.325 (3.264, 9.385)
Tiotropium 2.5 μg Add-on to > 400 μg budesonide + ≥1 controller or 200–400 μg budesonide + ≥2 controllers	6–11	265 265	Trough: 2.350 (−0.909, 5.609) Peak: 3.587 (0.540, 6.634)
Montelukast
Castro-Rodriguez 2010 Meta-analysis: Montelukast 5 mg QD Add-on to 200–800 μg/day budesonide	5–18	188^a	0.09 (−0.07, 0.25)^b
Simons 2001 Montelukast 5 mg QD + budesonide 200 μg BID vs budesonide 200 μg BID	6–14	279	1.3 (− 0.1, 2.7)^b
Miraglia del Giudice 2007 Montelukast 5 μg QD + budesonide 200 μg BID vs budesonide 200 μg BID	7–11	48	10.8 (NR)^b
Zhao 2015 Network meta-analysis: Montelukast 4–10 mg QD add-on to 100–200 μg/day budesonide	≤18	NR
Stelmach 2007 Montelukast 5–10 μg QD + 200 μg budesonide BID vs 200 μg budesonide BID	6–18	76	2.6 (NR)^b
Stelmach 2015 Montelukast 5 mg QD add-on to 200–600 μg budesonide^e	6–14	76	2.5 (NR)^b,f

BID twice daily, CI confidence interval, FEV₁ forced expiratory volume in 1 s, ICS inhaled corticosteroid, LABA long-acting β₂-agonist, NR not reported, QD once daily
^aTotal n number for the treatment arms being compared. ^bTime of measurement relevant to dosing (peak/trough) not specified. ^cHigh-dose ICS defined as > 400 μg budesonide (aged 12–14 years)/800–1600 μg budesonide (aged 15–17 years). ^dMedium-dose ICS defined as 200–400 μg budesonide (aged 12–14 years)/400–800 μg budesonide (aged 15–17 years). ^eICS dose was adjusted during the course of this study. ^fChange from placebo was not significantly different (P = 0.229)

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