Safety and Efficacy of Salmeterol in Patients with Asthma

18 Mar, 14

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Salmeterol PMDI is Safe and Efective in Indian Asthmatics

Objective

To compare efficacy and safety of Salmeterol-HFA pMDI (SEROBID; 25 mcg/actuation; Cipla Ltd., India) versus Salmeterol-CFC pMDI (25 mcg/actuation; Allen and Hanburys, UK).

Patients and Methods

Randomized, double-blind, parallel-group, multicentre study.
Subjects aged 12-65 years with confirmed diagnosis of asthma.
277 subjects were included and randomised to a 12-week treatment with 2 puffs b.i.d. of either Salmeterol-HFA pMDI or Salmeterol-CFC pMDI or a placebo pMDI.

Results

1. Efficacy

There were no significant differences between the two treatment groups (Salmeterol-HFA pMDI vs. Salmeterol-CFC pMDI) in mean values of morning PEF over 12 weeks.

Morning PEF (L/min) over 12 weeks

2. Safety and Tolerability

Adverse events of similar nature and number were reported in both treatment groups.

Conclusion

Salmeterol-HFA pMDI is clinically as effective as salmeterol-CFC pMDI.
The safety profile of the two treatment groups was also similar.

P2151, presented at European Respiratory Society (ERS) Conference, 2007

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