Table 1

Summary of characteristics of included trials

StudyDesign and trial lengthCOPD diagnosis criteria and severityAge range (years)InterventionTreatment duration and follow-up frequencyPrimary efficacyOther outcomes
Outcome
Pauwels 24Parallel, double-blind, placebo-controlled, international, multicentreSpirometry test30–65Budesonide 400 µg two times per day (n=458)3 years;Change in post-bronchodilator FEV1 over timeNone
(9 European countries);50% < FEV1 < 100%Placebo (n=454)Every 3 months(mL/yr)
3.5 years
Zheng22Parallel, double-blind, placebo-controlled, multicentre (China);Spirometry test40–79Fluticasone propionate/salmeterol 500/50 µg two times per day (n=297)6 months;Pre-bronchodilator FEV1 (mL)Post-bronchodilator FEV1 (L)
6.5 months25% < FEV1 < 69%Placebo (n=148)Week 0,2,4,8,12,16,20 and 24Health status
Night-time awakenings
Supplemental salbutamol use
Snoeck-Stroband 18Post-hoc analysis. Parallel, double-blind, placebo and active controlled, single centre (Netherlands);Spirometry test45–75Fluticasone 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 years30% < FEV1 < 80%Placebo (n=24)Every 3 monthsDyspnoea score
Health status
Wedzicha 23Parallel, double-blind, non-inferiority, multicentre (43 countries worldwide) ; 52 weeksSpirometry test≥40Indacterol/glycopyrronium 110/50 µg (n=1680)Exacerbations at week 52Annual rate of COPD exacerbationsNone
25% < FEV1 < 60%Salmeterol/fluticasone propionate 50/500 µg (n=1682)
mMRC ≥2; ≥1 exacerbation in past year
Hinds20Secondary 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≥40Fluticasone furoate/vilanterol 50/25 µg OR 100/25 µg OR 200/25 µg two times per day (n=1092)52 weeksAnnual rate of moderate-to-severe exacerbationsNone
Vilanterol 25 µg (n=386)
Bhatt21Prespecified 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 history40–80Fluticasone furoate/vilanterol 100/25 µg (n=4121)3, 6, 9 and 12 monthsChange in post-bronchodilator FEV1Annual rate of moderate-to-severe exacerbations
Fluticasone furoate 100 µg (n-4135)
Vilanterol 25 µg (n=4118)SGRQ
Placebo (n=4111)
Pascoe 19Secondary analysis. Randomised, double-blind, parallel, 52 week, multicentreCAT score ≥10, FEV1 ≤50% and ≥1 moderate/severe exacerbation in last year OR FEV1 50%–80% and ≥2 moderate/severe exacerbation in last year≥40Fluticasone furoate/vilanterol 100/25 µg (n=4125)52 weeksAnnual rate of moderate-to-severe exacerbationsSGRQ
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.