Fluticasone Propionate via Diskus[TM] Inhaler at Half the Microgram Dose of Budesonide via Turbuhaler[TM] Inhaler

R. Backman, Lohjan Aluesairaala, Keuhkopoliklinikka, Sairaalantie, Lohja, Finland; C. Baumgarten, Abteilung für Klinische Immunologie und Asthma Poliklinik im Rudolf-Virchow, Berlin, Germany; R.K. Sharma, GlaxoSmithKline Research and Development, Stockley Park, United Kingdom

Clin Drug Invest. 2001;21(11) 

In This Article

Abstract and Introduction

Objective: To evaluate the efficacy and tolerability of two inhaled corticosteroid treatment regimens, fluticasone propionate (FP) delivered from a DiskusTM inhaler and budesonide delivered from a TurbuhalerTM inhaler, in adult patients with asthma.
Design and Setting: This was an open, randomised, multicentre, parallel group study conducted in nine countries.
Patients: 277 patients with asthma, aged 18 to 87 years, with mean baseline forced expiratory volume in 1 second (FEV1) 75% predicted and treated with 400 to 1200 µg/day of inhaled corticosteroid, were randomised to treatment.
Interventions: 137 patients received FP 250 µg twice daily from a DiskusTM inhaler and 140 received budesonide 600 µg twice daily from a TurbuhalerTM inhaler for 4 weeks.
Results: No significant differences were seen between the two treatments for mean morning peak expiratory flow recorded on a daily record card [95% confidence limit (CL) for difference -5.1, 11.3 L/min, p = 0.46] or for any other efficacy parameter. A significant difference in adjusted geometric mean morning serum cortisol level after 4 weeks' treatment was seen in favour of FP (ratio of FP adjusted mean to budesonide adjusted mean 1.29, 95% CL 1.14, 1.47 nmol/L, p < 0.001). Device handling assessments favoured the DiskusTM inhaler; 81% of patients used the DiskusTM inhaler correctly first time compared with 61% for the TurbuhalerTM inhaler.
Conclusions: Administration of FP at less than half the microgram dosage of budesonide was as effective and caused less hypothalamic-pituitary-adrenal axis suppression measured by serum cortisol levels. The DiskusTM inhaler was also generally rated more highly by patients than the TurbuhalerTM inhaler.

Inhaled corticosteroids are acknowledged to be the most effective anti-inflammatory therapy for asthma and across the range of severities of the condition are recognised as the preferred preventive therapy.[1] The clinical efficacy of fluticasone propionate (FP) in the treatment of asthma is now well established.[2,3,4] FP is available in a number of inhalation devices including the pressurised metered-dose inhaler (pMDI) and dry powder breath-operated devices, the DiskhalerTM and Diskus/AccuhalerTM The DiskusTM is the most recently introduced device,[5,6] and has been shown to be clinically equivalent to FP administered via the DiskhalerTM inhaler.[7] It has been shown to be easy to use and is preferred by patients to other powder inhalers.[8,9]

Comparisons have been made of the relative efficacy of FP and a variety of other widely used anti-asthma drugs including budesonide. FP has been demonstrated to be at least as effective as budesonide when given at half the microgram dosage of budesonide.[10,11,12,13] This has been shown for FP compared with budesonide given either via the pMDI or TurbuhalerTM even though it has been claimed that there is superior deposition of drug from the TurbuhalerTM compared with the pMDI.[14]

This study was therefore set up to compare the tolerability and efficacy of FP 250 µg twice daily via DiskusTM inhaler and budesonide 600 µg twice daily via TurbuhalerTM inhaler in patients already using moderate doses of inhaled corticosteroids. As it is important that patients are able to use their inhalers correctly and that they like the inhaler they are using, device handling was also investigated in the study.

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