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BF Spiromax appears safe, tolerable for asthma treatment
Patients safely tolerated budesonide and formoterol Spiromax as a treatment for asthma and showed greater patient satisfaction for the intervention compared with budesonide and formoterol Turbuhaler, according to recent research.
“[Budesonide and formoterol] BF Spiromax 160/4.5 mcg was shown to be similar to BF Turbuhaler 200/6 mcg in relation to efficacy and safety in the treatment of asthma; however, specific domains of the [Patient Satisfaction and Preference Questionnaire for Inhalation Devices] PASAPQ showed greater benefits with Spiromax over Turbuhaler,” J. Christian Virchow, MD, from the department of pneumology/intensive care medicine at the University of Rostock in Rostock, Germany, and colleagues wrote in their study. “The PASAPQ analysis suggests that Spiromax was superior to Turbuhaler for all the performance domains. No differences (statistical or numerical) were observed when comparing the total convenience scores for Spiromax and Turbuhaler.”
Virchow and colleagues evaluated 290 patients receiving BF Spiromax 160/4.5 mcg two times per day with 284 patients receiving BF Turbuhaler 200/6 mcg over a 12-week phase 3b, multicenter, double-blind, double-dummy, randomized controlled trial, according to the abstract. The patients were a minimum of 12-years-old with a diagnosis of asthma and had received a short-acting β2 agonist and an inhaled corticosteroid for 8 weeks prior to the start of the trial. Researchers examined the weekly average of daily trough morning peek expiratory flow (PEF) as well as PASAPQ scores, changes in evening PEF from baseline, through forced expiratory volume in 1 second (FEV1), safety and changes in symptom-free and rescue-free 24-hour periods.
They found the least squares change for morning PEF at week 12 from baseline was 18.8 L/min in the BF Spiromax group and 21.8 L/min in the BF Turbuhaler group, according to the abstract. BF Spiromax was deemed non-inferior compared to BF Turbuhaler based on the lower limit of the 95% confidence interval of −9.02 L/min (non-inferiority criteria = −15 L/min).
At week 12, the mean difference in total performance scores for BF Spiromax and BF Turbuhaler were 0.353 compared with 0.248 at baseline (P < 0.001). Virchow and colleagues found no statistical or numerical differences between total convenience domain score between BF Spiromax and BF Turbuhaler, although they noted patient device preference and willingness to continue favored BF Spiromax both at baseline and at week 12 (P = 0.0005), according to the abstract. – by Jeff Craven
Disclosure: Virchow is a paid consultant for Allergopharma, ALK, Asche/Chiesi, AstraZeneca, Avontec, Bayer, Bencard, Bionorica, Boehringer Ingelheim, Essex/Schering-Plough, GlaxoSmithKline, Janssen-Cilag, Laboratorios Leti, Meda Pharmaceuticals, Merck, Merck Sharp & Dohme, Mundipharma, Novartis, Nycomed/ALTANA, Pfizer, Revotar Biopharmaceuticals, Sandoz/Hexal, Stallergenes, Takeda, Teva, UCB/Schwarz Pharma and Zydus Cadila; is on the advisory boards for Asche Chiesi, Avontec, Boehringer Ingelheim, Essex/Schering-Plough, GlaxoSmithKline, Janssen-Cilag, Merck/MSD, Mundipharma, Novartis, Revotar Biopharmaceuticals, Sandoz/Hexal, Sanofi, Takeda, Teva and UCB/Schwarz Pharma; and received grants from Deutsche Forschungsgemeinschaft, Land Mecklenburg-Vorpommern, GlaxoSmithKline and Merck Sharp & Dohme. The other researchers report various financial disclosures. Please see the full study for a complete list of disclosures.