New Delhi: The Subject Expert Committee functional under the Central Drugs Standard Control Organization (CDSCO) has given its nod to AstraZeneca to conduct the study of Budesonide Glycopyrronium. However, permission has been granted based on the condition that the firm should include more government sites across India.
In order to assess the effect of triple therapy with budesonide/glycopyrrolate/formoterol fumarate metered-dose inhaler (BGF MDI) relative to budesonide/formoterol fumarate metered-dose inhaler (BFF MDI) or Symbicort pMDI on lung function in participants with inadequately controlled asthma, the firm presented their proposal along with study protocol before the committee at 50th SEC meeting (Pulmonary) held on 26.02.2021 and 01.03.2021 at CDSCO HQ New Delhi.
Budesonide is a glucocorticoid that acts as an anti-inflammatory and immunomodulator. Budesonide is given by a metered-dose inhaler or nebulizer for maintenance and prophylactic treatment of asthma. Glycopyrronium belongs to antimuscarinic bronchodilators.
Further, it was stated that in terms of assessment of risk vs. benefit to the patients, the safety profile of the study drug from various preclinical toxicology studies and clinical studies justify the conduct of the trial. The test drug Budesonide Glycopyrronium may potentially provide an alternative treatment option in patients with Inadequately Controlled Asthma.
After detailed deliberation, the committee recommended the grant of permission to conduct the study subject to the condition that the firm should include more government sites across India.
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