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This randomised, double blind/open two phase multicentre study, sponsored by Astra Zeneca, was conducted over 7 months to find out if asthma control was better when patients adjusted the maintenance dose of inhaled budesonide/formoterol (Symbicort Turbohaler) according to asthma symptoms than when fixed dose (FD) regimens were used.
Eligible patients were randomised to one of three groups: (1) Symbicort FD 160/4.5 µg, two inhalations twice daily (bd); (2) Symbicort adjustable maintenance dose (AMD) 160/4.5 µg, two inhalations bd; or (3) salmeterol/fluticasone FD (Seretide Diskus) 50/250 µg, one inhalation bd. The study consisted of three treatment periods: run in (10–14 days), double blind (1 month with either Symbicort FD or Seretide FD), and open extension (6 months). In the open extension phase, those in the Symbicort AMD arm were advised to reduce the number to one inhalation bd or to increase the number of inhalations to four bd for at least 7 days according to the frequency of reliever usage and nocturnal awakenings due to asthma.
Symbicort FD significantly increased FEV1 compared with Seretide FD (p<0.05). Comparable improvements in FEV1 were observed with Symbicort AMD and Seretide FD. Patients in the Symbicort AMD group had significantly fewer exacerbations/hospital attendances/oral steroid courses (p<0.018) and lower use of reliever medication (p<0.01) than those in the Seretide FD group. There was no difference in the number of “well controlled asthma weeks” (WCAW) between the two FD groups, but Symbicort AMD increased the odds of achieving a WCAW compared with Symbicort FD (p = 0.049).
The results suggest that FD regimens with Symbicort and Seretide provide similar levels of asthma control. Total drug usage was lower with Symbicort AMD than FD. This study reinforces the need for home management plans and empowerment of patients to manage their asthma at home.