ArticleJournal of thoracic disease2026
Efficacy and safety of TQC3403 in patients with chronic obstructive pulmonary disease (COPD): a multicenter, randomized, open-label, phase 3 equivalence trial.
Article in Journal of thoracic disease, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
Background: Although dual bronchodilators represent the cornerstone of pharmacological therapy for chronic obstructive pulmonary disease (COPD), few affordable generic products are available worldwide. This study aimed to evaluate the clinical equivalence between TQC3403 [the first generic umeclidinium/vilanterol (UMEC/VI) dry powder inhaler (DPI)] and ANORO Methods: This multicenter, randomized, open-label, phase 3 equivalence trial was conducted at 56 centers in China. Eligible patients with moderate-to-severe COPD were randomized in a 1:1 ratio to receive either TQC3403 or ANORO Results: A total of 414 patients were enrolled, with 207 in each group. Baseline demographic and clinical characteristics of the two groups were similar. The LSM difference in the change in trough FEV Conclusions: TQC3403 demonstrated clinical equivalence to ANORO Trial registration: The clinical research was registered at Chinese Clinical Trial Register (Ref: ChiCTR2600120078).
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