New Delhi: Pharmaceutical major, Glenmark has got the green signal from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct the Phase IV clinical trial of the fixed dose combination (FDC) Glycopyrrolate plus Budesonide plus Formoterol Fumarate dihydrate actuation delivers inhalation aerosol.
However, this approval is subjected to a condition that the follow-up of the study should be up to 06 months, the details of the last visit including the test parameters should be mentioned in 6th month and telephonic follow-up should be done in the 4th and 5th months to assess the symptom analysis so as to rule out any worsening or exacerbation.
This came after the drug major Glenmark presented the Phase IV Clinical trial protocol before the committee as per the condition mentioned in Form CT-23 dated 13.05.2022,
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 cough, wheezing, and trouble breathing by increasing the flow of air through the bronchial tubes.
At the recent SEC meeting for Pulmonary held on March 21st 2023, the expert panel reviewed the Phase IV Clinical trial protocol of the FDC Glycopyrrolate plus Budesonide plus Formoterol Fumarate dihydrate actuation delivers inhalation aerosol.
After detailed deliberation, the committee recommended for conducting the Phase IV CT with the following conditions:
1. The follow-up of the study should be up to 06 months.
2. The details of the last visit including the test parameters should be mentioned at 06 months accordingly.
3. Telephonic follow-up should be done in the 4th and 5th months to assess the symptom analysis so as to rule out any worsening or exacerbation.
In addition, the expert panel suggested that the result of the study should be presented before the committee for review.
