AstraZeneca gets CDSCO Panel nod to study Budesonide, Glycopyrronium and Formoterol Fumarate
New Delhi: The drug major AstraZeneca has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct the phase III clinical study of Budesonide, Glycopyrronium, and Formoterol Fumarate.
This came after the firm presented Phase III clinical study protocol No. : D5989C00001: CSP Version 2.0 dated 28 Jan 2024. Addendum IND-1, Version 1.0, 10 Jan 2024.
This is a randomized, double-blind, parallel-group, multi-center, Phase III study to assess the efficacy of Budesonide, Glycopyrronium, and Formoterol Fumarate metered dose inhalers relative to Glycopyrronium and Formoterol Fumarate MDI on cardiopulmonary outcomes in Chronic Obstructive Pulmonary Disease.
Budesonide, glycopyrrolate, and formoterol combination is used as long-term maintenance treatment of chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. This medicine helps improve and reduce the number of flare-ups of the symptoms of COPD.
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