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.
Inhaled budesonide belongs to the family of medicines known as corticosteroids (cortisone-like medicines). It works by preventing inflammation (swelling) in the lungs that causes an asthma attack.
Glycopyrrolate and formoterol are long-acting bronchodilators. Bronchodilators are medicines that are breathed in through the mouth to open up the bronchial tubes (air passages) in the lungs. They relieve coughing, wheezing, and trouble breathing by increasing the flow of air through the bronchial tubes.
At the recent SEC meeting for pulmonary held on 3rd October 2024, the expert panel reviewed the Phase III clinical study protocol No. : D5989C00001: CSP Version 2.0 dated 28 Jan 2024. Addendum IND-1, Version 1.0, 10 Jan 2024.
After detailed deliberation, the committee recommended a grant of permission to conduct the trial as presented by the firm.
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