. 2020 Apr 15;10(4):e037509. doi: 10.1136/bmjopen-2020-037509

Table 1.

Summary of characteristics of included trials

Study	Design and trial length	COPD diagnosis criteria and severity	Age range (years)	Intervention	Treatment duration and follow-up frequency	Primary efficacy	Other outcomes
Study	Design and trial length	COPD diagnosis criteria and severity	Age range (years)	Intervention	Treatment duration and follow-up frequency	Outcome	Other outcomes
Pauwels ²⁴	Parallel, double-blind, placebo-controlled, international, multicentre	Spirometry test	30–65	Budesonide 400 µg two times per day (n=458)	3 years;	Change in post-bronchodilator FEV₁ over time	None
	(9 European countries);	50% < FEV₁ < 100%		Placebo (n=454)	Every 3 months	(mL/yr)
	3.5 years
Zheng²²	Parallel, double-blind, placebo-controlled, multicentre (China);	Spirometry test	40–79	Fluticasone propionate/salmeterol 500/50 µg two times per day (n=297)	6 months;	Pre-bronchodilator FEV₁ (mL)	Post-bronchodilator FEV₁ (L)
	6.5 months	25% < FEV₁ < 69%		Placebo (n=148)	Week 0,2,4,8,12,16,20 and 24		Health status
							Night-time awakenings
							Supplemental salbutamol use
Snoeck-Stroband ¹⁸	Post-hoc analysis. Parallel, double-blind, placebo and active controlled, single centre (Netherlands);	Spirometry test	45–75	Fluticasone propionate 500 µg two times per day (n=26)	2.5 years;	Inflammatory cell counts in bronchial biopsies (10⁷/m2) and induced sputum (10⁴/mL)	Post-bronchodilator FEV₁ (L)
	7 years	30% < FEV₁ < 80%		Placebo (n=24)	Every 3 months		Dyspnoea score
	7 years	30% < FEV₁ < 80%		Placebo (n=24)	Every 3 months		Health status
Wedzicha ²³	Parallel, double-blind, non-inferiority, multicentre (43 countries worldwide); 52 weeks	Spirometry test	≥40	Indacterol/glycopyrronium 110/50 µg (n=1680)	Exacerbations at week 52	Annual rate of COPD exacerbations	None
		25% < FEV₁ < 60%		Salmeterol/fluticasone propionate 50/500 µg (n=1682)
		mMRC ≥2; ≥1 exacerbation in past year		Salmeterol/fluticasone propionate 50/500 µg (n=1682)
Hinds²⁰	Secondary analysis. Randomised, double-blind, parallel group, 52 week, multicentre study (16 countries worldwide)	FEV₁ of ≤70% predicted and a (FVC) ratio of ≤0.7 after bronchodilator use; ≥1 exacerbation in previous year	≥40	Fluticasone furoate/vilanterol 50/25 µg OR 100/25 µg OR 200/25 µg two times per day (n=1092)	52 weeks	Annual rate of moderate-to-severe exacerbations	None
Hinds²⁰			≥40	Vilanterol 25 µg (n=386)	52 weeks	Annual rate of moderate-to-severe exacerbations	None
Bhatt²¹	Prespecified secondary analysis. Randomised, double-blind, 52 week, multicentre (43 countries worldwide)	FEV₁ of 50%–70% predicted and a (FVC) ratio of ≤0.7 after bronchodilator use; ≥10 pack-year smoking history	40–80	Fluticasone furoate/vilanterol 100/25 µg (n=4121)	3, 6, 9 and 12 months	Change in post-bronchodilator FEV₁	Annual rate of moderate-to-severe exacerbations
				Fluticasone furoate 100 µg (n-4135)			Annual rate of moderate-to-severe exacerbations
				Vilanterol 25 µg (n=4118)			SGRQ
				Placebo (n=4111)			SGRQ
Pascoe ¹⁹	Secondary analysis. Randomised, double-blind, parallel, 52 week, multicentre	CAT score ≥10, FEV₁ ≤50% and ≥1 moderate/severe exacerbation in last year OR FEV₁ 50%–80% and ≥2 moderate/severe exacerbation in last year	≥40	Fluticasone furoate/vilanterol 100/25 µg (n=4125)	52 weeks	Annual rate of moderate-to-severe exacerbations	SGRQ
				Umeclidinium/vilanterol 62.5/25 µg (n=2065)

CAT, COPD assessment test; COPD, chronic obstructive pulmonary disease; FEV₁, forced expiratory volume in 1 s; FVC, forced vital capacity; µg, micrograms; mL/yr, millilitres per year; mMRC, modified Medical Research Council dyspnoea scale; SGRQ, St. George's Respiratory Questionnaire.