Key Trials

This page contains several publication summaries that cover key clinical trials for bronchodilator monotherapy, LABA/LAMA, ICS/LABA, ICS/LABA/LAMA and switching treatments in COPD.

Bronchodilator monotherapy

Tiotropium versus salmeterol for the prevention of exacerbations of COPD

This article reports the results of the Prevention Of Exacerbations with Tiotropium (POET) in COPD study.

A 4-year trial of tiotropium in chronic obstructive pulmonary disease

This is an original research paper reporting results of the Understanding Potential Long-Term Impacts on Function with Tiotropium (UPLIFT) trial.


LABA/LAMA

Blood eosinophils and response to maintenance chronic obstructive pulmonary disease treatment: data from the FLAME trial

This secondary manuscript examines the relationship between baseline blood eosinophils and the rate of exacerbation in indacaterol/glycopyrronium versus salmeterol/fluticasone through analysis of FLAME data.

Indacaterol–Glycopyrronium versus Salmeterol–Fluticasone for COPD

The FLAME trial investigated whether the long-acting β2-agonist indacaterol plus the long-acting muscarinic antagonist glycopyrronium once daily would be at least as effective as the LABA salmeterol plus the inhaled corticosteroid fluticasone twice daily.

LANTERN: a randomized study of QVA149 versus salmeterol/fluticasone combination in patients with COPD

The LANTERN study investigated the efficacy and safety of LABA/LAMA bronchodilator indacaterol/glycopyrronium versus twice daily SFC.

Analysis of chronic obstructive pulmonary disease exacerbations with the dual bronchodilator QVA149 compared with glycopyrronium and tiotropium (SPARK): a randomised, double-blind parallel-group study

The SPARK study evaluated the effects of the once-daily dual LABA/LAMA bronchodilator QVA149 versus the once-daily LAMAs glycopyrronium and tiotropium on exacerbations of COPD.

Efficacy and safety of once-daily QVA149 compared with twice-daily salmeterol-fluticasone in patients with chronic obstructive pulmonary disease (ILLUMINATE)

The ILLUMINATE study investigated the efficacy, safety and tolerability of the once-daily dual LABA/LAMA bronchodilator QVA149 versus the LABA/ICS combination salmeterol–fluticasone.


ICS/LABA

Effectiveness of fluticasone furoate-vilanterol for COPD in clinical practice

The Salford Lung Study investigated the effectiveness of a combination of once-daily fluticasone furoate-vilanterol (FF/VI) compared with existing maintenance therapy.

Fluticasone furoate and vilanterol and survival in chronic obstructive pulmonary disease with heightened cardiovascular risk (SUMMIT): a double-blind randomised controlled trial

The Study to Understand Mortality and MorbidITy (SUMMIT) investigated whether combination treatment with an ICS and a LABA would improve survival compared with placebo.


ICS/LABA/LAMA

Single inhaler triple therapy versus inhaled corticosteroid plus long-acting β2-agonist therapy for chronic obstructive pulmonary disease (TRILOGY)

TRILOGY investigated whether a fixed-dose combination of beclometasone dipropionate, formoterol fumarate and glycopyrronium bromide would be as effective as BDP/FF in COPD.


Switching treatments

Efficacy and safety of direct switch to indacaterol/glycopyrronium in patients with moderate COPD: the CRYSTAL open-label randomised trial

The CRYSTAL study investigated the impact of a direct switch to glycopyrronium or indacaterol/glycopyrronium from previous standard-of-care treatments on lung function and dyspnea in symptomatic patients with moderate COPD.

Long-term triple therapy de-escalation to indacaterol/glycopyrronium in COPD patients (SUNSET): a randomised, double-blind, triple-dummy clinical trial

SUNSET was the first randomised controlled trial to investigate the efficacy and safety of direct de-escalation from triple therapy (ICS/LABA+LAMA) to dual bronchodilation (LABA/LAMA) in patients with moderate-to-severe COPD who do not frequently exacerbate.

Withdrawal of inhaled glucocorticoids and exacerbations of COPD

This study (referred to as WISDOM) investigated the effects of stepwise withdrawal of ICS from triple therapy (ICS + LABA + LAMA) to LABA/LAMA.

INSTEAD: a randomised switch trial of indacaterol versus salmeterol/fluticasone in moderate COPD

The INSTEAD study investigated the efficacy of the once-daily LABA bronchodilator indacaterol compared with the twice-daily LABA/ICS combination of salmeterol/fluticasone.