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Efficacy and safety of once-daily single-inhaler triple therapy in patients with inadequately controlled asthma: the CAPTAIN trial

Iñigo Ojanguren, María Florencia Pilia
Breathe 2021 17: 200279; DOI: 10.1183/20734735.0279-2020
Iñigo Ojanguren
1Servei de Pneumología, Hospital Universitari Vall d´Hebron, Departament de Medicina, Universitat Autònoma de Barcelona (UAB), Barcelona, Spain
2Institut de Recerca (VHIR), Barcelona, Spain
3CIBER de Enfermedades Respiratorias (CIBERES), Barcelona, Spain
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  • ORCID record for Iñigo Ojanguren
  • For correspondence: iojanguren@vhebron.net
María Florencia Pilia
1Servei de Pneumología, Hospital Universitari Vall d´Hebron, Departament de Medicina, Universitat Autònoma de Barcelona (UAB), Barcelona, Spain
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Tables

  • Table 1

    Unpooled analysis of least squares mean change in FEV1 from baseline to week 24

    FF/VI 100/25 µg plusFF/VI 200/25 µg plus
    No UMECUMEC 31.25 µgUMEC 
62.5 µgNo UMECUMEC 31.25 µgUMEC 
62.5 µg
    Subjects n379381390385384391
    Changes from baseline in trough FEV1 mL at week 2424 (−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 24Ref.+96 (52–139)
    p<0.0001
    +110 (66–153)
    p<0.0001
    Ref.+82 (39–125)
    p<0.0002
    +92 (49–135)
    p<0.0001

    Data 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 plusFF/VI 200/25 µg plus
      No UMECUMEC 31.25 µgUMEC 62.5 µgNo UMECUMEC 31.25 µgUMEC 
62.5 µg
      Subjects n407405406406404408
      Mean annualised moderate and/or severe exacerbations rate0.87 (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/VIRef.1.01 (0.72–1.42), p=0.961.07 (0.76–1.50), p=0.69Ref.0.98 
(0.66–1.45), p=0.930.88 
(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 designPrimary outcomeSecondary outcomeResultsLimitationsAdverse eventsComments
        Kerstjens [1]Two replicates, RCTsChange from baseline FEV1 at week 24
        Time to first severe asthma exacerbation
        Peak and trough FEV1 and FVC at each treatment visit
        Time to the first asthma exacerbation
        Addition of tiotropium significantly increased the time to the first severe exacerbation and provided modest sustained bronchodilationInconsistency in the results between two trialsMost 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 weeks
        Change from baseline in peak
        FEV1 at week 26
        Average morning PEF over the first 26 weeks in each study
        Rate of severe exacerbations
        Addition of a LAMA (glycopyrronium) improves lung function and reduces exacerbationsMuch lower rate of severe exacerbations observed during the studies than reported in historical dataSimilar across treatment groups
        Most events were mild
        Lee [3]Double-blind, randomised, parallel-group, phase 3A study (CAPTAIN)Change from the baseline FEV1 at week 24Annualised rate of moderate and/or severe asthma exacerbations
        Change from baseline in SGRQ
        Change from baseline in ACQ-7 total score
        Adding UMEC improved lung function but did not lead to a significant reduction in moderate and/or severe exacerbationsLow rate of exacerbations compared to other studies
        Most patients received a lower ICS dose compared to their usual baseline dose during run-in/stabilisation period
        Similar across treatment groups (dry mouth/drying of the airway secretions)
        Most events were mild
        Post-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.

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        Efficacy and safety of once-daily single-inhaler triple therapy in patients with inadequately controlled asthma: the CAPTAIN trial
        Iñigo Ojanguren, María Florencia Pilia
        Breathe Mar 2021, 17 (1) 200279; DOI: 10.1183/20734735.0279-2020

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        Efficacy and safety of once-daily single-inhaler triple therapy in patients with inadequately controlled asthma: the CAPTAIN trial
        Iñigo Ojanguren, María Florencia Pilia
        Breathe Mar 2021, 17 (1) 200279; DOI: 10.1183/20734735.0279-2020
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