Patient Satisfaction and Clinical Outcomes with Budesonide plus Formoterol Spiromax for Asthma and Chronic Obstructive Pulmonary Disease: A Real-World, Observational Trial

Abstract

Background: The fixed-dose combination of budesonide/formoterol (B/F) has been available in the Spiromax® dry powder inhaler since 2014. Objectives: To assess patient satisfaction, inhaler use errors, and disease control in patients with asthma or chronic obstructive pulmonary disease (COPD) treated with B/F Spiromax. Methods: This non-interventional, prospective, 12-week study enrolled consecutive asthma or COPD patients who had recently begun treatment with B/F Spiromax or were switched from another inhaled corticosteroid/long-acting β₂-agonist combination to B/F Spiromax in routine clinical practice. Patients recruited from 243 specialist respiratory clinics or general practices in Germany were assessed for patient satisfaction (Satisfaction with Inhalers and Preference questionnaire), inhaler application errors (modified Easy Low Instruction over Time checklist), disease control, and safety. Results: The population included 3,943 patients: asthma n = 2,707 (68.7%); COPD n = 1,236 (31.3%). At baseline, 60.1% of patients were “satisfied” or “very satisfied” with their previous inhaler, and this increased to 88.8% at week 12 of B/F Spiromax use. Overall, 62.1% of pre-treated patients preferred B/F Spiromax to their old inhaler. The frequency of any handling error observed with B/F Spiromax at week 12 was lower than at baseline (11.9 vs. 25.5% of patients, respectively). After 12 weeks, 77.4% were assessed as having improved (minimally, much, or very much) overall health status versus baseline. Guideline-defined disease severity (as rated by physicians) and patient-reported symptom severity improved during the study in both asthma and COPD patients. B/F Spiromax was well tolerated. Conclusion: B/F Spiromax was associated with high patient satisfaction, low device handling error rate, and improvements in clinical outcomes in real-world clinical practice.

General Practitioner Use of Generically Substitutable Inhaler Devices and the Impact of Training on Device Mastery and Maintenance of Correct Inhaler Technique

“…Consistent with previous research among HCPs and patients, this study among practicing GPs confirmed that maintaining device mastery is problematic [7,[45][46][47][48]. It can be argued that 100% of prescribers should be maintaining correct IT after training, however despite this, we have found that maintaining correct IT was more likely with the Spiromax Ò than with the Turbuhaler Ò .…”

“…The presentation of these two devices was consistent with the way in which each of the two manufacturers supply their ''placebo'' inhalers. We believe that this does in fact mimic the sensations experienced by patients when using these medication-filled devices [45,[47][48][49], however do recognize that it may be a source of bias in this study. The presence of lactose in the Spiromax Ò does equate to a feedback mechanism associated with use of this device.…”

“…While the primary aim of this study was to evaluate intuitive IT, which is not necessarily impacted by feedback mechanisms, it is foreseeable that this feedback mechanism could influence participant preference. Research indicates that feedback mechanisms can impact user device preference in both a positive and negative way [3,45,60,61]. ''Taste'' (such as that associated with the deposition of lactose in the mouth) is a polarizing feature that can sometimes be associated with a decreased preference for a device but can also be a feature associated with increased preference due to the feedback feature [47].…”

“…It can only be noted that the use of these placebo devices delivers an experience that mimics that of a device containing an active ingredient used by patients in real life. That is, when a patient uses a Turbuhaler Ò , there is a lack of sensation of drug delivered and when Spiromax Ò is used, there is the sensation of lactose delivery in the mouth [45][46][47][48][49].…”

Effect of montelukast/budesonide formoterol powder inhalation in chronic obstructive pulmonary disease

“…Currently, the combination of different treatment methods is preferred for the treatment of COPD [14]. The treatment for COPD includes the use of bronchodilators and anti-inflammatory drugs to relieve the symptoms of airway obstruction and inhibit airway inflammation [15]. Clinically, the commonly used drugs are inhaled corticosteroids, which effectively relieve the clinical symptoms of COPD patients.…”