title: QVA149 (indacaterol/glycopyrronium fixed-dose combination): a review of its use in patients with chronic obstructive pulmonary disease.
abstract: QVA149 (indacaterol/glycopyrronium) [Xoterna(®) Breezhaler(®), Ultibro(®) Breezhaler(®)] is an inhaled fixed-dose combination of indacaterol (a long-acting selective β2-adrenergic receptor agonist [LABA]) and glycopyrronium (a long-acting muscarinic receptor antagonist [LAMA]) that has been approved in the EU and Japan for the symptomatic control of chronic obstructive pulmonary disease (COPD) in adults. In phase III studies, QVA149 significantly improved bronchodilation versus indacaterol, glycopyrronium or tiotropium alone and the LABA/inhaled corticosteroid fixed-dose combination salmeterol/fluticasone. These improvements in lung function, which were rapid in onset and maintained during long-term treatment, were generally associated with significant improvements in dyspnoea, health status, COPD exacerbation risk, patient symptoms, and rescue medication use. The SHINE and ILLUMINATE studies in low (exacerbation) risk patients with moderate to severe disease suggest that QVA149 may offer more symptomatic relief than tiotropium and salmeterol/fluticasone. Similarly, the SPARK study in high (exacerbation) risk patients with severe or very severe disease showed that QVA149 was more effective than glycopyrronium in preventing moderate to severe exacerbations, and suggests that QVA149 may offer more symptomatic relief than LAMA monotherapy. Another phase III study comparing QVA149 with salmeterol/fluticasone in high-risk patients with moderate to very severe disease (FLAME) is ongoing. QVA149 is generally well tolerated, with no new safety signals identified compared with its monocomponents. Bronchodilators remain central to the symptomatic management of COPD. When dual bronchodilation is indicated, QVA149 offers the convenience of two bronchodilators in a single inhaler coupled with a simple, once-daily dosing regimen that may encourage better treatment adherence. Therefore, it is a valuable option in the treatment of COPD.
authors.affiliation: Adis, 41 Centorian Drive, Private Bag 65901, Mairangi Bay, North Shore, 0754, Auckland, New Zealand, demail@springer.com.
authors.forename: James E
authors.initials: JE
authors.lastname: Frampton
mesh_terms: D000280:Administration, Inhalation; D001993:Bronchodilator Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*; D017326:Clinical Trials, Phase III as Topic; D004338:Drug Combinations; D006024:Glycopyrrolate / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000493:pharmacokinetics / Q000627:therapeutic use; D006801:Humans; D007189:Indans / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*; D029424:Pulmonary Disease, Chronic Obstructive / Q000175:diagnosis / Q000188:drug therapy*; D015363:Quinolones / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*; D012129:Respiratory Function Tests; D012720:Severity of Illness Index; D016896:Treatment Outcome
chemical_list: D001993:Bronchodilator Agents; D004338:Drug Combinations; D007189:Indans; D015363:Quinolones; C554862:indacaterol-glycopyrronium combination; D006024:Glycopyrrolate