Lupin Gets CDSCO Panel Nod for Phase IV CT of pulmonary FDC drug
New Delhi: Pharmaceutical major, Lupin has got the go ahead from the Subject Expert Committee (SEC) functional under Central Drug Standard Control Organization (CDSCO) to conduct a Phase IV clinical trial of the fixed-dose combination Mometasone furoate plus Glycopyrronium bromide plus Indacaterol acetate Inhalation Powder
This came after the firm presented the Phase IV clinical trial protocol before the committee as per the condition mentioned in Form CT-23 dated 07.11.2022.
Mometasone furoate is a corticosteroid used to treat asthma, allergic rhinitis, nasal congestion, nasal polyps, dermatitis, and pruritus. Mometasone acts as a Corticosteroid Hormone Receptor Agonist.
Glycopyrronium bromide belongs to a group of medicines called “anticholinergics”. These medicines help to prevent the formation of secretions that can cause problems in respiratory tract.
Indacaterol belongs to the class of drugs known as long-acting beta agonists (LABAs). Indacaterol is also known as a bronchodilator. It works by relaxing the muscles around the airways so that they open up and one can breathe more easily. This medication should not be used for severe/sudden breathing problems.
At the recent SEC meeting for Pulmonary held on 21 March 2023, the expert panel reviewed the Phase IV clinical trial protocol of Mometasone furoate plus Glycopyrronium bromide plus Indacaterol acetate Inhalation Powder
After detailed deliberation, the committee recommended conducting the Phase IV CT with the following conditions:
1. Adverse events should be elaborated.
2. The follow-up of the study should be up to 06 months.
3. The details of the last visit including the test parameters should be mentioned at 06 months accordingly.
4. Telephonically 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.
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