Nifty  22419.95  -150.40  (-0.67%)

Sensex  73730.16  -609.28  (-0.82%)

USDINR  83.35  0.02  (0.02%)

Cipla successfully complete Phase 3 clinical study for fluticasone propionate and salmeterol inhalat
(03 Apr 2020)
Cipla announced the successful completion of Phase-3 clinical end-point study for fluticasone propionate and salmeterol inhalation powder (100/50 mcg).

Fluticasone propionate and salmeterol inhalation powder 100/50 mcg, 250/50 mcg and 500/50 mcg are generic versions of GSK's Advair Diskus®. The product is indicated to treat asthma in patients 4 years and older as a twice-daily prescription medicine and in long term to treat chronic obstructive pulmonary disease (COPD), including chronic bronchitis, emphysema, or both, for better breathing and fewer flare-ups.

The Phase-3 study, successfully completed in the first attempt, was conducted over a period of 15 months at over 100 sites in the US enrolling 1400 asthma patients. The study results demonstrate that Cipla's fluticasone propionate and salmeterol inhalation powder 100/50 mcg is therapeutically equivalent to Advair Diskus® 100/50mcg. The study demonstrated therapeutic equivalence by assessing the primary end points which is in accordance with regulatory recommendations and guidelines. There were no safety concerns identified during the trials.