Tables
- Table 1
Unpooled analysis of least squares mean change in FEV1 from baseline to week 24
FF/VI 100/25 µg plus FF/VI 200/25 µg plus No UMEC UMEC 31.25 µg UMEC 62.5 µg No UMEC UMEC 31.25 µg UMEC 62.5 µg Subjects n 379 381 390 385 384 391 Changes from baseline in trough FEV1 mL at week 24 24 (−6–55) 120 (89–151) 134 (104–165) 76 (45–106) 157 (127–188) 168 (137–198) Changes in FEV1 mL by adding UMEC at week 24 Ref. +96 (52–139)
p<0.0001+110 (66–153)
p<0.0001Ref. +82 (39–125)
p<0.0002+92 (49–135)
p<0.0001Data are presented as least squares mean (95% CI), unless otherwise stated. The p-values are not adjusted for multiplicity.
- Table 2
Analysis of mean annualised rate of moderate and/or severe exacerbations in the unpooled intention-to-treat population at weeks 1 to 52
FF/VI 100/25 µg plus FF/VI 200/25 µg plus No UMEC UMEC 31.25 µg UMEC 62.5 µg No UMEC UMEC 31.25 µg UMEC 62.5 µg Subjects n 407 405 406 406 404 408 Mean annualised moderate and/or severe exacerbations rate 0.87 (0.73–1.04) 0.76 (0.64–0.92) 0.68 (0.56–0.82) 0.57 (0.47–0.69) 0.61 (0.50–0.74) 0.55 (0.45–0.67) FF/UMEC/VI versus FF/VI Ref. 1.01 (0.72–1.42), p=0.96 1.07 (0.76–1.50), p=0.69 Ref. 0.98 (0.66–1.45), p=0.93 0.88 (0.60–1.31), p=0.54 Data are presented as rate ratio (95% CI), unless otherwise stated. The p-values are not adjusted for multiplicity.
- Table 3
Summary of the randomised controlled trials (RCTs) analysing triple therapy with LAMA, LABA and ICS in a single inhaler in asthma
First author [ref.] Study design Primary outcome Secondary outcome Results Limitations Adverse events Comments Kerstjens [1] Two replicates, RCTs Change from baseline FEV1 at week 24
Time to first severe asthma exacerbationPeak and trough FEV1 and FVC at each treatment visit
Time to the first asthma exacerbationAddition of tiotropium significantly increased the time to the first severe exacerbation and provided modest sustained bronchodilation Inconsistency in the results between two trials Most events were mild
Dry mouth (<2% all patients, but was reported more frequently in the tiotropium group than in the placebo group)Virchow [2] Two parallel-group, double-blind, randomised, active-controlled, phase 3 trials (TRIMARAN and TRIGGER) Change from pre-dose FEV1 at week 26
Annualised rate of moderate/severe exacerbations over 52 weeksChange from baseline in peak
FEV1 at week 26
Average morning PEF over the first 26 weeks in each study
Rate of severe exacerbationsAddition of a LAMA (glycopyrronium) improves lung function and reduces exacerbations Much lower rate of severe exacerbations observed during the studies than reported in historical data Similar across treatment groups
Most events were mildLee [3] Double-blind, randomised, parallel-group, phase 3A study (CAPTAIN) Change from the baseline FEV1 at week 24 Annualised rate of moderate and/or severe asthma exacerbations
Change from baseline in SGRQ
Change from baseline in ACQ-7 total scoreAdding UMEC improved lung function but did not lead to a significant reduction in moderate and/or severe exacerbations Low rate of exacerbations compared to other studies
Most patients received a lower ICS dose compared to their usual baseline dose during run-in/stabilisation periodSimilar across treatment groups (dry mouth/drying of the airway secretions)
Most events were mildPost-hoc and prespecified subgroup analyses by biomarkers of type 2 inflammation FVC: forced vital capacity; PEF: peak expiratory flow; SGRQ: St George's Respiratory Questionnaire; ACQ: Asthma Control Questionnaire.
Vol 17 Issue 1
Table of Contents
Efficacy and safety of once-daily single-inhaler triple therapy in patients with inadequately controlled asthma: the CAPTAIN trial
