Safety and Efficacy of Formoterol in Patients with Asthma

18 Mar, 14

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Formoterol PMDI is Safe and Effective in Indian Asthmatics

Objective

To compare efficacy and safety of Formoterol (Foratec; 12 mcg/actuation; Cipla Ltd., India) HFA pressurized metered dose inhaler (pMDI) versus Formoterol- CFC pMDI (12 mcg/actuation; Novartis, UK).

Patients and Methods

Randomized, double-blind, parallel-group, multicentre study.
Subjects aged 12-65 years with confirmed diagnosis of asthma.
280 subjects were included and randomized to a 12 week treatment with 1 puff b.i.d. of either Formoterol-HFA pMDI or Formoterol-CFC pMDI or a placebo pMDI.

Results

1. Efficacy

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

Mean morning PEFR over 12 weeks

2. Safety and Tolerability

The incidence of adverse events was similar in the two treatment groups.
Most common adverse events were headache, rhinitis and allergic rhinitis.

Conclusion

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

P2153, presented at European Respiratory Society (ERS) Conference, 2007

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