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Efficacy and safety of once-daily QVA149 compared with the free combination of once-daily tiotropium plus twice-daily formoterol in patients with moderate-to-severe COPD (QUANTIFY): a randomised, non-inferiority study.
Thorax. 2015 Apr; 70(4):311-9.T

Abstract

BACKGROUND

QVA149 is a once-daily (o.d.) inhaled dual bronchodilator containing a fixed-dose combination of the long-acting β2-agonist indacaterol and the long-acting muscarinic antagonist glycopyrronium for the treatment of COPD. The QUANTIFY study compared QVA149 with a free-dose bronchodilator combination of tiotropium plus formoterol (TIO+FOR) in improving health-related quality of life (HRQoL) of patients with COPD.

METHODS

This multicentre, blinded, triple-dummy, parallel-group, non-inferiority study randomised patients aged ≥40 years with moderate-to-severe COPD (post-bronchodilator forced expiratory volume in 1 s (FEV1) ≥30% to <80% predicted) to QVA149 110/50 µg o.d. or TIO 18 µg o.d.+ FOR 12 µg twice daily (1:1) for 26 weeks. The primary endpoint was to demonstrate non-inferiority in HRQoL assessed using St George's Respiratory Questionnaire-COPD (SGRQ-C). The prespecified non-inferiority margin was 4 units. Secondary endpoints included Transition Dyspnoea Index (TDI) score, pre-dose FEV1, forced vital capacity (FVC) and safety.

RESULTS

Of the 934 patients randomised (QVA149=476 and TIO+FOR=458), 87.9% completed the study. At week 26, non-inferiority was met for SGRQ-C (QVA149 vs TIO+FOR; difference: -0.69 units; 95% CI -2.31 to 0.92; p=0.399). A significantly higher percentage of patients achieved a clinically relevant ≥1 point improvement in TDI total score with QVA149 (49.6%) versus TIO+FOR (42.4%; p=0.033). QVA149 significantly increased pre-dose FEV1 (+68 mL, 95% CI 37 mL to 100 mL; p<0.001) and FVC (+74 mL, 95% CI 24 mL to 125 mL; p=0.004) compared with TIO+FOR at week 26. The incidence of adverse events was comparable between both treatments (QVA149=43.7% and TIO+FOR=42.6%).

CONCLUSIONS

QVA149 is non-inferior to TIO+FOR in improving HRQoL, with clinically meaningful and significant improvements in breathlessness and lung function in patients with COPD.

TRIAL REGISTRATION NUMBER

NCT01120717.

Authors+Show Affiliations

III.Medizinische Klinik und Poliklinik, Universitätsmedizin der Johannes Gutenberg-Universität Mainz K.d.ö.R., Mainz, Germany.Universitätsklinikum Leipzig, Leipzig, Germany POIS Leipzig GbR, Leipzig, Germany.Pneumologische Praxis, Marburg, Germany.Kardio-Pneumologische Praxis, Berlin, Germany.Novartis Pharma GmbH, Nürnberg, Germany.Novartis Pharma GmbH, Nürnberg, Germany.Universitätsmedizin der Johannes Gutenberg-Universität, Mainz, Germany.

Pub Type(s)

Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

25677679

Citation

Buhl, Roland, et al. "Efficacy and Safety of Once-daily QVA149 Compared With the Free Combination of Once-daily Tiotropium Plus Twice-daily Formoterol in Patients With Moderate-to-severe COPD (QUANTIFY): a Randomised, Non-inferiority Study." Thorax, vol. 70, no. 4, 2015, pp. 311-9.
Buhl R, Gessner C, Schuermann W, et al. Efficacy and safety of once-daily QVA149 compared with the free combination of once-daily tiotropium plus twice-daily formoterol in patients with moderate-to-severe COPD (QUANTIFY): a randomised, non-inferiority study. Thorax. 2015;70(4):311-9.
Buhl, R., Gessner, C., Schuermann, W., Foerster, K., Sieder, C., Hiltl, S., & Korn, S. (2015). Efficacy and safety of once-daily QVA149 compared with the free combination of once-daily tiotropium plus twice-daily formoterol in patients with moderate-to-severe COPD (QUANTIFY): a randomised, non-inferiority study. Thorax, 70(4), 311-9. https://doi.org/10.1136/thoraxjnl-2014-206345
Buhl R, et al. Efficacy and Safety of Once-daily QVA149 Compared With the Free Combination of Once-daily Tiotropium Plus Twice-daily Formoterol in Patients With Moderate-to-severe COPD (QUANTIFY): a Randomised, Non-inferiority Study. Thorax. 2015;70(4):311-9. PubMed PMID: 25677679.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and safety of once-daily QVA149 compared with the free combination of once-daily tiotropium plus twice-daily formoterol in patients with moderate-to-severe COPD (QUANTIFY): a randomised, non-inferiority study. AU - Buhl,Roland, AU - Gessner,Christian, AU - Schuermann,Wolfgang, AU - Foerster,Karin, AU - Sieder,Christian, AU - Hiltl,Simone, AU - Korn,Stephanie, Y1 - 2015/02/12/ PY - 2015/2/14/entrez PY - 2015/2/14/pubmed PY - 2015/6/10/medline KW - COPD Pharmacology SP - 311 EP - 9 JF - Thorax JO - Thorax VL - 70 IS - 4 N2 - BACKGROUND: QVA149 is a once-daily (o.d.) inhaled dual bronchodilator containing a fixed-dose combination of the long-acting β2-agonist indacaterol and the long-acting muscarinic antagonist glycopyrronium for the treatment of COPD. The QUANTIFY study compared QVA149 with a free-dose bronchodilator combination of tiotropium plus formoterol (TIO+FOR) in improving health-related quality of life (HRQoL) of patients with COPD. METHODS: This multicentre, blinded, triple-dummy, parallel-group, non-inferiority study randomised patients aged ≥40 years with moderate-to-severe COPD (post-bronchodilator forced expiratory volume in 1 s (FEV1) ≥30% to <80% predicted) to QVA149 110/50 µg o.d. or TIO 18 µg o.d.+ FOR 12 µg twice daily (1:1) for 26 weeks. The primary endpoint was to demonstrate non-inferiority in HRQoL assessed using St George's Respiratory Questionnaire-COPD (SGRQ-C). The prespecified non-inferiority margin was 4 units. Secondary endpoints included Transition Dyspnoea Index (TDI) score, pre-dose FEV1, forced vital capacity (FVC) and safety. RESULTS: Of the 934 patients randomised (QVA149=476 and TIO+FOR=458), 87.9% completed the study. At week 26, non-inferiority was met for SGRQ-C (QVA149 vs TIO+FOR; difference: -0.69 units; 95% CI -2.31 to 0.92; p=0.399). A significantly higher percentage of patients achieved a clinically relevant ≥1 point improvement in TDI total score with QVA149 (49.6%) versus TIO+FOR (42.4%; p=0.033). QVA149 significantly increased pre-dose FEV1 (+68 mL, 95% CI 37 mL to 100 mL; p<0.001) and FVC (+74 mL, 95% CI 24 mL to 125 mL; p=0.004) compared with TIO+FOR at week 26. The incidence of adverse events was comparable between both treatments (QVA149=43.7% and TIO+FOR=42.6%). CONCLUSIONS: QVA149 is non-inferior to TIO+FOR in improving HRQoL, with clinically meaningful and significant improvements in breathlessness and lung function in patients with COPD. TRIAL REGISTRATION NUMBER: NCT01120717. SN - 1468-3296 UR - https://www.unboundmedicine.com/medline/citation/25677679/Efficacy_and_safety_of_once_daily_QVA149_compared_with_the_free_combination_of_once_daily_tiotropium_plus_twice_daily_formoterol_in_patients_with_moderate_to_severe_COPD__QUANTIFY_:_a_randomised_non_inferiority_study_ L2 - https://thorax.bmj.com/lookup/pmidlookup?view=long&amp;pmid=25677679 DB - PRIME DP - Unbound Medicine ER -