Include more Govt sites: CDSCO panel to Zydus Healthcare on clinical trial of Pulmonary disease drug
New Delhi: Citing that more Govt. sites should be included, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has granted permission to Zydus Healthcare to conduct the Phase III clinical trial of fixed dose combination metered dose inhaler containing Vilanterol Trifenatate eq. to Vilanterol 12.5mcg plus Glycopyrrolate IP eq. to Glycopyrronium 25mcg plus Fluticasone furoate 50mcg.
This came after the firm presented their proposal along with Phase III Clinical Trial protocol for Vilanterol Trifenatate eq. to Vilanterol 12.5mcg plus Glycopyrrolate IP eq. to Glycopyrronium 25mcg plus Fluticasone furoate 50mcg metered dose inhaler.
Vilanterol is a long-acting beta2-adrenergic agonist used in combination with other bronchodilators for the management of chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. 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). Increases in cyclic AMP are associated with relaxation of bronchial smooth muscle and inhibition of release of hypersensitivity mediators from mast cells in the lungs.
Glycopyrronium is an anticholinergic agent used to treat hyperhidrosis, severe drooling, chronic obstructive pulmonary disease (COPD), used with other medications to treat ulcers, and used in anesthesia. Inhaled glycopyrrolate is used to treat air flow blockage and prevent worsening of chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.
Fluticasone is a corticosteroid indicated in the treatment of corticosteroid responsive dermatoses, asthma, and COPD. Fluticasone acts by inhibiting inflammatory cells, such as mast cells, neutrophils, lymphocytes, and macrophages. Fluticasone helps to inhibit the secretion of histamines, cytokines, and leukotrienes that are commonly released with asthma and allergic responses.
At the recent SEC meeting for Pulmonary, the expert panel reviewed the proposal along with Phase III CT protocol for metered dose inhaler of Vilanterol Trifenatate eq. to Vilanterol 12.5mcg plus Glycopyrrolate IP eq. to Glycopyrronium 25mcg plus Fluticasone furoate 50mcg.
After detailed deliberation, the committee recommended the grant of permission to conduct the Phase III clinical trial with the condition that more Govt. sites should be included.
