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Paediatric Pulmonology and Allergology
2005 October, Vol. VIII, No. 2 (2990-3005)
ADJUSTABLE MAINTENANCE DOSING WITH BUDESONIDE / FORMOTEROL COMPARED WITH FIXED-DOSE SALMETEROL / FLUTICASONE IN MODERATE TO SEVERE ASTHMA
R. Aalbers1, V. Backer2, T. T. K. Kava3, E. R. Omenaas4, T. Sandstrom5, C. Jorup6, T. Welte7
1 Department of Pulmonology, Martini Hospital, Groningen, The Netherlands;
2 Respiratory Unit, Department of Internal Medicine, Bispebjerg Hospital, Copenhagen, Denmark;
3 Department of Respiratory Medicine, Central Hospital of Northern Karelia, Joensuu, Finland;
4 Centre for Clinical Research, Haukeland University Hospital, Bergen, Norway;
5 Department of Respiratory Medicine and Allergy, University Hospital, Umeå, Sweden;
6 AstraZeneca R&D Lund, Lund, Sweden;
7 Department of Pneumology and Intensive Care Medicine, University of Magdeburg, Magdeburg, Germany
Current asthma guidelines recommend that patients are educated to adjust their medication according to their asthma severity using physician guided self-management plans. However, many patients take a fixed dose of their controller medication and adjust their reliever medication according to asthma symptoms. This study examined whether asthma control improved if patients adjusted the maintenance dose (AMD) of budesonide / formoterol (Symbicort Turbuhaler 160/4.5 mcg) according to asthma severity compared with traditional fixed dosing (FD) regimens. Symptomatic patients with asthma (n = 658, mean symptom score 1.5, mean inhaled corticosteroids 735 mcg/day, FEV1 84 perc. predicted) were randomised after 2 weeks’ run-in to either: budesonide / formoterol AMD, budesonide / formoterol FD or salmeterol / fluticasone (Seretide Diskus 50/250 mcg) FD. In a 4 week double-blind period, both budesonide / formoterol AMD and FD groups received two inhalations twice daily (bid) and salmeterol / fluticasone FD patients received one inhalation bid. In the following 6 month open extension, both FD groups continued with the same treatment. Patients in the AMD group with well controlled asthma stepped down to one inhalation bid; others continued with two inhalations bid. All AMD patients could increase to four inhalations bid for 7–14 days if symptoms worsened. All patients used terbutaline or salbutamol for symptom relief throughout. The primary variable was the odds of achieving a well-controlled asthma week (WCAW). The odds ratio for achieving a WCAW did not differ between the FD regimens; however, during the open period, budesonide / formoterol AMD increased the odds of achieving a WCAW vs budesonide / formoterol FD (odds ratio 1.335; 95 perc. CI: 1.001, 1.783; p = 0.049) despite a 15 perc. reduction in average study drug use. Budesonide / formoterol AMD patients had a lower exacerbation rate over the study: 40 perc. lower vs salmeterol / fluticasone FD (p = 0.018); 32 perc. lower vs budesonide / formoterol FD (NS). During the double-blind period, there were no clinically relevant differences between the budesonide / formoterol FD and salmeterol / fluticasone FD groups. Budesonide / formoterol AMD patients used less reliever medication in the open extension: 0.58 vs 0.92 occasions / day for budesonide / formoterol FD (p = 0.001) and 0.80 occasions / day for salmeterol / fluticasone FD (p = 0.011). It was concluded that adjustable maintenance dosing with budesonide / formoterol provides more effective asthma control by reducing exacerbations and reliever medication usage compared with fixed dose salmeterol / fluticasone.
(Curr Med Research Opin 2004; 20(2): 225–240).