PURPOSE: To assess patient satisfaction with budesonide (BUD) and formoterol (FM) in one pressurized metered-dose inhaler (BUD/FM pMDI) in adults with moderate to severe persistent asthma previously receiving inhaled corticosteroids.
METHODS: This 12-week, randomized, double-blind, double-dummy, placebo-controlled, multicenter study (SD-039-0717) included 596 patients aged ≥12 years with moderate to severe asthma previously receiving inhaled corticosteroids. After a 2-week run-in period on BUD pMDI 80 μg × 2 inhalations (160 μg) twice daily (bid), patients were randomized to receive 2 inhalations bid of BUD/FM pMDI 160/4.5 μg (320/9 μg), BUD pMDI 160 μg (320 μg) + FM dry powder inhaler (DPI) 4.5 μg (9 μg), BUD pMDI 160 μg (320 μg), FM DPI 4.5 μg (9 μg), or placebo. The analysis plan to assess patient satisfaction in patients ≥18 years (n=553) was developed a priori to include 3 indices (Control Relief, Perception of Medication, and Comparison with Other Medications) of the Patient Satisfaction with Asthma Medication (PSAM) questionnaire (1) (scale: 0 to 100; higher values=greater satisfaction). The Inhaler index of the PSAM questionnaire was not included, as it is not relevant for double-dummy studies. Index scores (calculated as the mean score for items in each index) at the end of treatment (defined as the last valid score during treatment) were compared using analysis of variance.
RESULTS: Mean scores were significantly higher (P≤;.001) for BUD/FM pMDI compared with BUD pMDI, FM DPI, and placebo in all 3 indices of the PSAM questionnaire: Control Relief (74.0 vs 58.3, 62.1, and 43.7, respectively), Perception of Medication (74.4 vs 59.0, 63.8, and 45.9, respectively), and Comparison with Other Medications (65.0 vs 44.7, 53.2, and 29.5, respectively).
CONCLUSION: BUD/FM pMDI combination treatment resulted in significantly greater patient-reported satisfaction with asthma treatment for each PSAM index evaluated compared with its monocomponents and placebo in this patient population.
CLINICAL IMPLICATIONS: The greater patient satisfaction observed with BUD/FM pMDI combination therapy compared with monotherapy may encourage further use and promote adherence. 1. Mathias SD, et al. Qual Life Res. 2000;9:873–82.
DISCLOSURE: James Baker, Grant monies (from industry related sources) AstraZeneca, GlaxoSmithKline, Apieron, Nioxx, Sanofi Aventis, Amgen, ALK, Altana, Medpointe, Centocor, Ivax, Johnson & Johnson, Wyeth; Consultant fee, speaker bureau, advisory committee, etc. AstraZeneca, Novartis, Merck; Product/procedure/technique that is considered research and is NOT yet approved for any purpose. The product discussed in this abstract (budesonide/formoterol pMDI) has been approved for use in patients with asthma. However, this abstract includes off-label discussions surrounding the effects of budesonide/formoterol pMDI on patient satisfaction.