Safety and Efficacy of Beclomethasone in Patients with Asthma

18 Mar, 14

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Beclomethasone PMDI is Safe and Efective in Indian Asthmatics

Objective

To compare safety of Beclomethasone-HFA (Beclate; Cipla Ltd., India) via pressurized metered dose inhaler (pMDI) versus Beclomethasone-CFC pMDI (Allen and Hanburys, UK).

Patients and Methods

Randomized, open-label, parallel-group study.
Subjects aged 18-70 years with confirmed diagnosis of asthma.
106 patients were included and randomised to 12 week treatment with either Beclomethasone-HFA (400-1200 mcg/day) or Beclomethasone-CFC (400-1200 mcg/day) or a placebo pMDI.

Results

1. Efficacy

There were no significant differences between the treatment groups (Beclomethasone-HFA pMDI vs. Beclomethasone-CFC pMDI) in mean values of FEV₁ over 12 weeks.

Mean FEV₁ (L) over 12 weeks

There was no significant difference in both the treatment groups for mean daytime and night-time asthma symptom scores at week 12.
The use of rescue medication was low throughout the study (mean of <1 puff/day).

2. Safety and Tolerability

There were no significant changes between both the treatment groups at week 12 in the mean change of corrected Urine Cortisol/Creatine (UCC) ratio from baseline (p < 0.9805).
Only 4 patients out of 106 experienced adverse events. Adverse events reported were oral candidiasis, back pain and upper respiratory tract infection.
All the adverse events were not related to the study medication and all either resolved or improved with treatment.

Conclusion

Beclomethasone-HFA pMDI was well tolerated when used in the long-term treatment of adults with mild to moderate persistent asthma.
Clinical efficacy of Beclomethasone-HFA pMDI was maintained throughout the study.

3285, presented at European Respiratory Society (ERS) Conference, 2005

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Related Topics

rescue medication

day-time symptoms

night-time symptoms

pressurized metered dose inhaler