Safety and Efficacy of Fluticasone + Salmeterol pMDI in Patients with Asthma

18 Mar, 14

Fluticasone + Salmeterol PMDI is Safe and Efective in Indian Asthmatics

Objective

To compare the clinical effect of the combination Fluticasone+Salmeterol-HFA pMDI (Seroflo; 125/25 µg; Cipla Ltd., India) versus concurrently used same doses of single products (Fluticasone-HFA pMDI 125 µg and Salmeterol-CFC pMDI 25 µg; Cipla Ltd., India).

Patients and Methods

Randomized, double-blind, parallel-group study.
Subjects aged 18-65 years with confirmed diagnosis of mild to moderate asthma.
360 subjects were included and randomised to a 12 week treatment with 2 puffs b.i.d. of either combination Fluticasone+Salmeterol-HFA pMDI or Fluticasone-HFA pMDI and Salmeterol-CFC pMDI both given concurrently or a placebo pMDI.

Results

1. Efficacy

There were no significant differences between the two treatment groups (combination Fluticasone+Salmeterol-HFA pMDI or Fluticasone-HFA pMDI and Salmeterol-CFC pMDI given concurrently) in mean values of morning PEF over 12 weeks.

Mean morning PEFR over 12 weeks

2. Safety and Tolerability

The incidence of adverse events during the 12-week treatment period was similar for both the treatment groups.
Most common adverse events reported were headache, pyrexia and cough which were of mild to moderate intensity.

Conclusion

Fluticasone + Salmeterol-HFA pMDI 125/25 µg is clinically as effective to Fluticasone-HFA pMDI 125 µg and Salmeterol-CFC pMDI 25 µg given concurrently.
Both the treatment groups were safe and well tolerated.

P3607, presented at European Respiratory Society (ERS) Conference, 2007

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