Safety and Efficacy of Fluticasone + Salmeterol in Patients with Asthma

18 Mar, 14

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Fluticasone + Salmeterol: Role in Treatment of Bronchial Asthma

Objective

Clinical evaluation of safety and efficacy of Fluticasone + Salmeterol (Seroflo Rotacaps; Cipla Ltd; India) given through dry powder inhaler (Rotahaler; Cipla Ltd; India) in the treatment of bronchial asthma.

Patients and Methods

Open, multicenter, non-comparative study in clinical practice situation.
80 patients were enrolled by 28 investigators from 15 cities in India.
Patients aged 12- 65 years with a diagnosis of mild to moderate asthma.
Fluticasone + Salmeterol (100/50) Rotacaps twice daily for 4 weeks.

Results

1. Clinical Efficacy

There was significant increase (by 29.13%) in mean FEV₁ from baseline after 4 weeks.

There was significant increase (by 31.82%) in mean PEFR from baseline after 4 weeks.

There was significant reduction in mean daytime symptom score and mean number of nocturnal awakenings from baseline at the end of 4 weeks.

2. Safety & Tolerability

In the present study, the fluticasone + salmeterol combination was well tolerated with the type of adverse effects reported similar to those with the two drugs.
No patient had to discontinue therapy due to any adverse event.
There was no increase in the incidence of adverse events.

Conclusion

Fluticasone + Salmeterol Rotacaps given through Cipla's dry powder inhaler is an effective and well tolerated therapy in the treatment of bronchial asthma.
It has the potential to improve patient compliance and consequently improve asthma control.

Indian Practitioner 2001; 54: 551-557.

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