Levosalbutamol Shows Similar Efficacy at Half the Dose of Salbutamol

18 Mar, 14

Levosalbutamol has Similar Efficacy at Half the Dose of Salbutamol

Objective

To compare efficacy of Levosalbutamol-CFC pressurized metered dose inhaler (pMDI) (Levolin; 100 mcg; Cipla Ltd., India) versus Salbutamol-CFC pMDI (Asthalin; 200 mcg; Cipla Ltd., India) in terms of bronchodilator responses.

Patients and Methods

Randomized, double-blind, single-dose, three-way crossover study.
Subjects aged 18-65 years with confirmed diagnosis of asthma.
30 subjects were included and were administered with single doses of 100 mcg Levosalbutamol or 200 mcg Salbutamol or a placebo via pMDI and a non-static spacer (Zerostat spacer; Cipla Ltd., India) on three separate days, at least three days apart.

Results

1. Efficacy

Single doses of 100 mcg levosalbutamol and 200 mcg racemic salbutamol produced equivalent bronchodilator responses over a period of 6 hr as measured by AUC.

Levosalbutamol and salbutamol produced an equivalent mean maximal increase in FEV₁.

Mean maximum increase in FEV₁ over 2 days

2. Safety

Both levosalbutamol and salbutamol produced a significant decrease in serum potassium level 1 hr after administration (4.61-4.25; P<0.001 and 4.39-4.13; P=0.004, respectively) compared to placebo (4.47-4.37; P= 0.19).
Both levosalbutamol and salbutamol produced a significant increase in pulse rate 60 min post administration (73.9-77.8 beats/min; P<0.05 and 72.4-77.3 beats/min; P<0.05, respectively).

Conclusion

Single dose of levosalbutamol pMDI with non-static Cipla spacer has similar efficacy at half the dose of Salbutamol pMDI in terms of bronchodilator response.
Both the treatment groups increased pulse rate and reduced serum potassium levels equally and hence show a similar safety profile.

Respir Med 2007; 101: 845-849.

Related Topics

bronchodilator response

pressurized metered dose inhaler