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Clinical Trial
. 2007 Nov;61(11):1874-83.
doi: 10.1111/j.1742-1241.2007.01574.x. Epub 2007 Sep 20.

Therapeutic comparison of a new budesonide/formoterol pMDI with budesonide pMDI and budesonide/formoterol DPI in asthma

A H Morice  1 , S Peterson, O Beckman, D Osmanliev
Affiliations
Clinical Trial

Therapeutic comparison of a new budesonide/formoterol pMDI with budesonide pMDI and budesonide/formoterol DPI in asthma

A H Morice et al. Int J Clin Pract. 2007 Nov.

Abstract

Background: Budesonide/formoterol is an effective treatment for both asthma and chronic obstructive pulmonary disease. This study compared the efficacy and safety of a novel hydrofluoroalkane (HFA) pressurised metered-dose inhaler (pMDI) formulation of budesonide/formoterol with that of budesonide pMDI and budesonide/formoterol dry-powder inhaler (DPI; Turbuhaler).

Methods: This was a 12-week, multinational, randomised, double-blind, double-dummy study involving patients aged > or = 12 years with asthma. All patients had a forced expiratory volume in 1 s of 50-90% predicted normal and were inadequately controlled on inhaled corticosteroids (500-1600 microg/day) alone. Following a 2-week run-in, during which they received their usual medication, patients were randomised (two inhalations twice daily) to budesonide pMDI 200 microg, budesonide/formoterol DPI 160/4.5 microg or budesonide/formoterol pMDI 160/4.5 microg. The primary efficacy end-point was change from baseline in morning peak expiratory flow (PEF).

Results: In total, 680 patients were randomised, of whom 668 were included in the primary analysis. Therapeutically equivalent increases in morning PEF were observed with budesonide/formoterol pMDI (29.3 l/min) and budesonide/formoterol DPI (32.0 l/min) (95% confidence interval: -10.4 to 4.9; p = 0.48). The increase in morning PEF with budesonide/formoterol pMDI was significantly higher than with budesonide pMDI (+28.7 l/min; p < 0.001). Similar improvements with budesonide/formoterol pMDI vs. budesonide pMDI were seen for all secondary efficacy end-points. Both combination treatments were similarly well tolerated.

Conclusions: Budesonide/formoterol, administered via the HFA pMDI or DPI, is an effective and well-tolerated treatment for adult and adolescent patients with asthma, with both devices being therapeutically equivalent.

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Figures

Figure 1
Figure 1
Change in morning PEF following treatment with budesonide pMDI, budesonide/formoterol DPI or budesonide/formoterol pMDI. DPI, dry-powder inhaler; NS, not significant; PEF, peak expiratory flow; pMDI, pressurised metered-dose inhaler
Figure 3
Figure 3
Change in FEV1 following treatment with budesonide pMDI, budesonide/formoterol DPI or budesonide/formoterol pMDI. DPI, dry-powder inhaler; E, enrolment; FEV1, forced expiratory volume in 1 s; pMDI, pressurised metered-dose inhaler; R, randomisation; W, week
Figure 2
Figure 2
Change in (A) total asthma symptoms and (B) reliever medication-free days following treatment with budesonide pMDI, budesonide/formoterol DPI or budesonide/formoterol pMDI. DPI, dry-powder inhaler; pMDI, pressurised metered-dose inhaler
Figure 4
Figure 4
Change in AQLQ(S) following treatment with budesonide pMDI, budesonide/formoterol DPI or budesonide/formoterol pMDI. AQLQ(S), Asthma Quality of Life Questionnaire (standardised version); DPI, dry-powder inhaler; pMDI, pressurised metered-dose inhaler. ***p < 0.001, **p < 0.01, *p < 0.05 vs. budesonide pMDI
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References

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