#Lama inhalers trial#
#Lama inhalers plus#

ICS, inhaled corticosteroid LABA, long-acting beta agonist LAMA, long-acting muscarinic antagonist. 6, 8 Figure 1 shows the key factors that should be used to decide which double combination to use in clinical practice, with more exacerbations and more eosinophils favouring ICS/LABA use.ДЇactors that determine efficacy of double combination inhalers in clinical practice. In both IMPACT and FLAME studies, the comparison of ICS/LABA versus LAMA/LABA varied with the blood eosinophil count, as ICS effects increased at higher counts.

#Lama inhalers plus#

1 For ICS, the individual risk of exacerbations and side effects should be considered (clinical information) plus the blood eosinophil count to predict efficacy 1, 7 (biomarker/biological information). 1, 7 Precision medicine in clinical practice involves using clinical and biological information to make individual treatment decisions that optimize the benefit versus risk ratio for pharmacological treatments. The current debate around double or triple combinations centres on the benefits versus risk of ICS. In the higher exacerbation risk IMPACT population, ICS/LABA was a better choice than LAMA/LABA, although triple therapy (ICS/LABA/LAMA) trumped both double combinations.

#Lama inhalers trial#

These run-in period issues reflect clinical trial design complexity, but the different exacerbation histories of the study populations are directly relevant to clinical practice. After run-in period, there was a direct switch to randomized treatment in IMPACT which could include ICS withdrawal clearly, this aspect may have favoured ICS-containing treatments. In contrast, the IMPACT study had a 2-week run-in period using the patient's own medication, thereby not introducing bias due to a treatment change during run-in period. This is much longer than most COPD randomized controlled trials and likely skewed the population towards patients with a lower disease burden who could manage with LAMA monotherapy for an extended run-in period. The FLAME study used a 6-week run-in period on tiotropium. The majority of FLAME participants had one exacerbation in the previous year (approximately 80%), while the IMPACT participants were at higher exacerbation risk. The real answer lies in the populations studied and the nature of the run-in periods before randomization.

This cannot account for a complete reversal of the result. Why is this result opposite to FLAME? A simplistic and mostly unhelpful explanation is that different molecules were studied. There was a 10% treatment difference on exacerbations over 1вЂ‰year in favour of ICS/LABA (fluticasone furoate/vilanterol) over LAMA/LABA (umeclidinium/vilanterol). 6 The IMPACT population was at high exacerbation risk 54% had в‰Ґ2 moderate or severe exacerbations and 26% had в‰Ґ1 severe exacerbation (hospitalization) in the previous year. 5 Did this weight of evidence close the case, LAMA/LABA beats ICS/LABA?Д¬ertainly not, the IMPACT (The Informing the Pathway of COPD Treatment) study created controversy. 1, 3, 4 Moreover, the FLAME study conducted in higher exacerbation risk patients (в‰Ґ1 exacerbation in the past year) showed superiority for LAMA/LABA over ICS/LABA for exacerbation prevention over 1вЂ‰year. 1, 2 Interest quickly moved to compare LAMA/LABA versus inhaled corticosteroid (ICS)/LABA combinations studies in low exacerbation risk patients showed a lung function advantage for LABA/LAMA and a benefit on symptoms. Early studies proved the advantage of LAMA/LABA combinations versus long-acting bronchodilator monotherapies. The development of inhalers containing both a long-acting muscarinic antagonist (LAMA) and a long-acting beta agonist (LABA) has increased the treatment options in chronic obstructive pulmonary disease (COPD).