Amend revised Phase IV CT protocol: CDSCO panel tells GSK on Respiratory Drug Combination

Published On 2023-01-03 12:15 GMT | Update On 2023-10-07 10:15 GMT

New Delhi: In response to the GSK's revised Phase IV clinical trial protocol for the pulmonary fixed dose combination (FDC) drug, Fluticasone Furoate100mg, Umeclidnium Bromide 62.5mg,Vilanterol Trifenatate 25mg powder for inhalation, the Subject Export Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has recommended the firm to amend the Phase IV clinical trial protocol.

This came after the drug major GSK presented the revised Phase IV clinical trial protocol of the pulmonary FDC drug Fluticasone Furoate100mg plus Umeclidnium Bromide62.5mg plus Vilanterol Trifenatate 25mg powder for inhalation before the committee.

The combination of fluticasone furoate, umeclidinium bromide, and vilanterol trifenatate is used to control wheezing, shortness of breath, coughing, and chest tightness caused by chronic obstructive pulmonary (COPD; a group of diseases that affect the lungs and airways, that includes chronic bronchitis and emphysema). It is also used in adults to control wheezing, shortness of breath, coughing, and chest tightness caused by asthma.

Fluticasone furoate is an inhaled corticosteroid that can be used as maintenance treatment of asthma and/or chronic obstructive pulmonary disease (COPD) depending on the product. Fluticasone furoate works through an unknown mechanism to affect the action of various cell types and mediators of inflammation but Fluticasone binds and activates glucocorticoid receptor, resulting in the activation of lipocortin. Lipocortin, in turn, inhibits cytosolic phospholipase A2, which triggers a cascade of reactions involved in the synthesis of inflammatory mediators, such as prostaglandins and leukotrienes.

Umeclidinium Bromide is the bromide salt form of umeclidinium, a muscarinic receptor antagonist, with bronchodilator activity.It works by blocking some receptors called muscarinic receptors, which control the contraction of muscles. When umeclidinium bromide is inhaled, it relaxes the muscles of the airways.

Vilanterol is in a class of medications called long-acting beta-agonists (LABAs).Its pharmacological effect is attributable to stimulation of intracellular adenylyl cyclase which catalyzes the conversion of adenosine triphosphate (ATP) to cyclic-3',5'-adenosine monophosphate (cAMP).

The combination of fluticasone furoate, umeclidinium bromide, and vilanterol trifenatate works by relaxing and opening air passages in the lungs, making it easier to breathe.

At the recent SEC meeting for Pulmonary held on 7th December 2022, the expert panel extensively reviewed the revised Phase IV clinical trail protocol of the pulmonary FDC drug Fluticasone Furoate100mg plus Umeclidnium Bromide62.5mg plus Vilanterol Trifenatate 25mg powder for inhalation presented by the drug major Glaxosmithkline Pharma.

After detailed deliberation, the committee recommended the amendment in the revised Phase IV clinical trial study protocol.

Also Read:Submit CT Protocol, Toxicity Report: CDSCO Panel Tells Glenmark On Respiratory Drug Combination

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Dr. Divya Colin

Dr. Divya Colin, a Doctor of Pharmacy Graduate with extensive experience in clinical and hospital settings and confidently equipped with diagnostic and therapeutic skills. She also has spread out exposure to Oncology Departments in Mysore Medical College and Research Institute as Oncology Pharmacist. Currently she is building a career in clinical research and clinical data management. She has been a part of Medical Dialogue since January 2022.

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Amend revised Phase IV CT protocol: CDSCO panel tells GSK on Respiratory Drug Combination

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