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- W1750313429 abstract "Background: Clinically, methacholine challenge has been widely used for the detection and quantitation of bronchial responsiveness. This study assessed the bronchoprotective effects of two salbutamol HFA pMDI formulations using methacholine challenge. Aim: The aim of this study was to evaluate equivalence between Salbutamol sulphate HFA pMDI (Cipla Ltd, India: test product) and Ventolin Evohaler HFA pMDI (Allen & Hanburys, UK: reference product) in terms of bronchoprotective effect against the methacholine challenge. Methods: This was a randomised, double blind, double dummy, four period, crossover study. At each treatment visit patients administered either one puff (100 μg) or two puffs (200 μg) of either the test or the reference product. On each of the treatment days, two methacholine challenge tests were performed, one before dosing & one 10 minutes after dosing. Other safety parameters (serum potassium, blood glucose, tremor and ECG) were also assessed at each treatment visit. Results: Out of 57 randomised patients 52 were included in the ITT & 46 in the PP population. The estimated mean difference in the PP population between the high dose (200 μg) of the two formulations was 0.2081 (95% CI -0.2400,0.6561) and between the low dose (100 μg) of the two formulations was -0.2362 (95% CI -0.6809, 0.2085). For both doses, the 95% CI was within clinically relevant equivalence limits of ± 1 DD. Conclusion: The bronchoprotective effect of salbutamol sulphate HFA pMDI (Cipla Ltd, India) against methacholine induced bronchoconstriction was equivalent to salbutamol sulphate HFA pMDI (Ventolin Evohaler, Allen & Hanburys, UK). Both the products were safe and well tolerated." @default.
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- W1750313429 date "2011-09-01" @default.
- W1750313429 modified "2023-10-17" @default.
- W1750313429 title "Comparison of the bronchoprotective effects of two salbutamol suplphate HFA pMDI using methacholine challenge testing" @default.
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