6533b7d3fe1ef96bd126133f

RESEARCH PRODUCT

Once-daily QVA149 improves dyspnoea and health status compared with tiotropium plus formoterol in patients without ICS use: A post-hoc analysis of the QUANTIFY study

Christian GessnerStephanie KornChristian SiederSimone HiltlRoland BuhlWolfgang SchürmannKarin Förster

subject

COPDmedicine.medical_specialtyPediatricsbusiness.industrymedicine.drug_classrespiratory systemmedicine.diseaserespiratory tract diseasesBronchodilatorInternal medicinePost-hoc analysisCopd assessment testmedicineIn patientFormoterolOnce dailybusinessLung functionmedicine.drug

description

Rationale: The QUANTIFY study compared the approved dual bronchodilator QVA149 with the free-dose combination of tiotropium plus formoterol (TIO+FOR) regarding lung function, dyspnoea and health status in patients with moderate-to-severe COPD. This post-hoc analysis reported on the subgroup of pts without ICS background therapy. Methods: This blinded, triple-dummy 26-week study randomised patients to QVA149 110/50 µg OD or TIO 18 µg OD plus FOR 12 µg b.i.d. (1:1). ICS was allowed as background therapy. Endpoints included lung function (trough FEV1), dyspnoea (TDI) and health status (COPD Assessment Test, CAT). Results: Of the 934 pts randomised (QVA149 [N=476] or TIO+FOR [N=458]); 87.9% completed the study. 41% of all pts had ICS background therapy, but only 2.6% of those were frequent exacerbators. The subgroup of patients without ICS, representing 59% of all pts (QVA 149 [N=275], TIO+FOR [N=274]), showed a statistically significant improvement in breathlessness (least square mean difference (LSMD) in TDI: 0.66; 95% CI: 0.08-1.24 p=0.027), lung function (LSMD trough FEV1: 77 mL, 95% CI: 33-120 mL, p Conclusion: QVA149 showed significant improvements in dyspnoea, health status and lung function in the subgroup of patients without ICS use compared with TIO+FOR free-dose combination.

https://doi.org/10.1183/13993003.congress-2015.pa1008