Respiratory medicine · 2025
Efficacy and safety of novel fixed dose combination of vilanterol, glycopyrronium, and fluticasone furoate dry powder inhaler: A phase 3, randomized, non-inferiority trial compared with fixed dose combination of indacaterol, glycopyrronium, and mometasone furoate dry powder inhaler in Indian asthma patients.
Клиническое исследование III фазыEquivalence TrialСтатьяМногоцентровое исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Patel Chintan, Sheth Vaishal, Koppula Ravi, Kumar Avadhesh, Bhate Amit S, Sahoo Diptikant, Jain Manish Kumar, Mondal Asish, Parmar Deven, Kansagra Kevinkumar, Shrivastava Rahul, Pathak Hardik
Аннотация
BACKGROUND: For managing persistent asthma, M/s. Zydus Healthcare Limited has developed a novel fixed dose combination (FDC) of vilanterol 25 μg, glycopyrronium 50 μg, and fluticasone furoate 200 μg (VIL-GLY-FF) in dry powder inhaler (DPI) formulation.
METHODS: This phase 3, multicenter, parallel group, open-label study randomized (1:1) patients not controlled with medium or high-dose inhaled corticosteroid in either the test (VIL-GLY-FF DPI) or reference (approved FDC DPI of indacaterol 150 μg, GLY 50 μg, and mometasone furoate 160 μg [IND-GLY-MF]) group. FDCs were administered by inhaling one capsule via Respihaler device once-daily for 12 weeks. The primary endpoint was the change in trough forced expiratory volume in 1 s (FEV1) at week 12 from baseline. Secondary outcomes included the comparison of trough forced vital capacity (FVC), post-bronchodilator FEV1 and FVC, and asthma control test score between the two groups.
FINDINGS: All 256 enrolled patients completed the study. The least square mean (standard error) change in trough FEV1 at week 12 from baseline was 392.77 (31.33) ml and 364.34 (31.33) ml for the test and reference groups (p = 0.522), respectively. The lower limit of 95 % confidence interval for the difference between two groups for the mean change in trough FEV1 at week 12 from baseline was -58.83 ml, well-above the predefined non-inferiority margin (-150 ml). Other secondary endpoints and safety were comparable between the two groups.
INTERPRETATION: VIL-GLY-FF DPI was found non-inferior to IND-GLY-MF DPI in improving trough FEV1 response. The test FDC was well-tolerated in Indian patients with persistent asthma.
CLINICAL TRIAL REGISTRATION NUMBER: CTRI/2024/02/063046 (Clinical Trial Registry - India).
METHODS: This phase 3, multicenter, parallel group, open-label study randomized (1:1) patients not controlled with medium or high-dose inhaled corticosteroid in either the test (VIL-GLY-FF DPI) or reference (approved FDC DPI of indacaterol 150 μg, GLY 50 μg, and mometasone furoate 160 μg [IND-GLY-MF]) group. FDCs were administered by inhaling one capsule via Respihaler device once-daily for 12 weeks. The primary endpoint was the change in trough forced expiratory volume in 1 s (FEV1) at week 12 from baseline. Secondary outcomes included the comparison of trough forced vital capacity (FVC), post-bronchodilator FEV1 and FVC, and asthma control test score between the two groups.
FINDINGS: All 256 enrolled patients completed the study. The least square mean (standard error) change in trough FEV1 at week 12 from baseline was 392.77 (31.33) ml and 364.34 (31.33) ml for the test and reference groups (p = 0.522), respectively. The lower limit of 95 % confidence interval for the difference between two groups for the mean change in trough FEV1 at week 12 from baseline was -58.83 ml, well-above the predefined non-inferiority margin (-150 ml). Other secondary endpoints and safety were comparable between the two groups.
INTERPRETATION: VIL-GLY-FF DPI was found non-inferior to IND-GLY-MF DPI in improving trough FEV1 response. The test FDC was well-tolerated in Indian patients with persistent asthma.
CLINICAL TRIAL REGISTRATION NUMBER: CTRI/2024/02/063046 (Clinical Trial Registry - India).