A Strategy to Reduce Out-of-User-Life Utilization and Waste of Expired Budesonide-Formoterol pMDI Inhalers in Mild Asthma.Annals of the American Thoracic Society • April 04, 2025
Since 2019, the Global Initiative for Asthma (GINA) has recommended that, for patients with mild asthma (GINA steps 1-2), clinicians preferentially prescribe as-needed budesonide-formoterol instead of as-needed albuterol to reduce the risk of severe exacerbations (1). However, there are unique barriers to adoption of this treatment paradigm in the United States (2). For example, in the United States, budesonide-formoterol is only available via a pressurized metered-dose inhaler (PMDI), which, per labeling, should be discarded 90 days after unpackaging (3). Budesonide-formoterol pMDI's user-life contrasts with budesonide-formoterol dry powder inhaler's (DPI) user-life, which is 24-36 months (4). Inhaler user-life refers to the time from inhaler unpackaging until the time the manufacturer no longer confirms potency and recommends disposal (5). Therefore, depending on how frequently patients use budesonide-formoterol PMDIs for symptoms, patients may be either using "expired inhalers" or discarding inhalers with remaining actuations.
In the United States, most clinicians prescribe a budesonide-formoterol PMDI with 120 actuations. A 60-actuation budesonide-formoterol PMDI is manufactured but is labeled for institutional use and not prescribed for outpatients (3). To our knowledge, no one has described how many as-needed budesonide-formoterol actuations patients with mild asthma utilize over 90 days (i.e., budesonide-formoterol PMDI's user-life). Thus, we analyzed data from four landmark trials to: 1) estimate how frequently patients with mild asthma would use as-needed budesonide-formoterol within 90 days; and 2) compare the annualized cost of 60-actuation versus 120-actuation budesonide-formoterol PMDIs if user-life was followed.
Prevalence and characteristics of adults with preserved ratio impaired spirometry (PRISm): Data from the BOLD Australia study.Chronic Respiratory Disease • January 23, 2025
Yijun Zhou, Maria Ampon, Michael Abramson, Alan James, Graeme Maguire, Richard Wood Baker, David Johns, Guy Marks, Helen Reddel, Brett Toelle
Background: Individuals with Preserved Ratio Impaired Spirometry (PRISm), defined as FEV1/FVC ≥0.7 and FEV1 <80% predicted, are at higher risk of developing COPD. However, data for Australian adults are limited. We aimed to describe prevalence of PRISm and its relationship with clinical characteristics in Australia. Method: Data from the Burden of Lung Disease (BOLD) Australia study of randomly selected adults aged ≥40 years from six sites was classified into airflow limitation, PRISm, or normal spirometry groups. Demographic, clinical characteristics, and lung function were compared between groups.
Results: Of the study sample (n = 3518), 387 (11%) had PRISm, 549 (15.6%) had airflow limitation, and 2582 (73.4%) had normal spirometry. PRISm was more common in Indigenous Australian adults. Adults with PRISm had more frequent respiratory symptoms, more comorbidities, greater health burden and poorer quality of life than those with normal spirometry. Pre- and post-bronchodilator FEV1 and FVC were lower in adults with PRISm than those with airflow limitation. Adults with PRISm were less likely to use respiratory medicine than those with airflow limitation (OR = 0.56, 95% CI 0.38-0.81).
Conclusions: PRISm was present in 11% of adults in this study and they had similar respiratory symptoms and health burden as adults with airflow limitation.
Optimizing asthma care in low-to-middle income countries through multisectoral collaboration: recommendation report of the first Philippine Asthma Assembly.Expert Review Of Respiratory Medicine • December 10, 2024
Lenora Fernandez, Helen Reddel, Dina Diaz, Camilo Roa, Ricardo Zotomayor, Josephine Ramos, Gregorio Ocampo, Maria Cruz, Rommel Punongbayan
Asthma is one of the most common noncommunicable diseases, raising serious concerns about asthma-related deaths globally. Studies have reported safety concerns with short-acting beta-agonists (SABAs) monotherapy. SABA overuse contributes significantly to the healthcare burden in the Philippines. Despite Global Asthma Network's years-long advocacy for equal access to essential medicines at affordable cost, the uptake of international healthcare policies is limited in most low- and middle-income countries, including the Philippines. We reviewed synthesis of targeted nonsystematic literature searches on prevalence of asthma and asthma-related mortality, SABA overreliance and its adverse events, alternatives to SABA, patient referral, and multidisciplinary team (MDT) approach for asthma management. We describe regional challenges and recommendations for improving asthma care through continued multisectoral collaboration. Use of medications like inhaled corticosteroid-formoterol combinations may aid in reducing adverse events including severe exacerbations, hospitalizations, complications from oral corticosteroid use, and long-term treatment costs. Raising patient awareness about preventive measures, proper inhaler techniques, and medication adherence can mitigate burden of uncontrolled asthma. Improving access to asthma medications alongside developing treatment algorithms and referral pathways (including MDT) for primary care physicians will pave the way for optimal asthma care in LMICs, including the Philippines.
Predicting Risk of Morbidities Associated with Oral Corticosteroid Prescription for Asthma.Pragmatic And Observational Research • August 02, 2024
Brooklyn Stanley, Jatin Chapaneri, Mina Khezrian, Ekaterina Maslova, Soram Patel, Mark Gurnell, Giorgio Canonica, Helen Reddel, Liam Heaney, Arnaud Bourdin, David Neil, Victoria Carter, David Price
Oral corticosteroids (OCS) are commonly used to treat asthma but increase the risks for multiple morbidities; reducing OCS exposure may benefit patients. We analysed independent risk factors and longitudinal changes in OCS usage among patients with asthma to predict future risks of OCS-related adverse outcomes. Optimum Patient Care Research Database United Kingdom primary care electronic medical records (EMR) from January 1990 to June 2021 were used to select adults (18-93 years) with asthma who had follow-up data from ≥2 years before to ≥3 years after an index visit for active symptoms; this date was defined by the largest pre-visit to post-visit change in mean annual OCS use. OCS usage during every follow-up year was categorised as none, low (mean <2 prescriptions/year), or high (mean ≥2 prescriptions/year). Pre-index to post-index changes between usage categories were calculated. Risk modelling selected cohorts without 17 morbidities (documented pre-index) reported to be associated with OCS exposure, including type 2 diabetes, osteoporosis, hypertension, and pneumonia. Cox regression analyses selected published risk factors associated with each condition and available in EMR for inclusion in proportional hazards models. The pre-index to post-index OCS usage category remained unchanged in 38.6% of patients, increased in 39.2%, and decreased in 22.2%, with 20.7% having no further OCS prescriptions. In models, the risks of all adverse outcomes increased with projected categoric OCS use; for example, hazard ratios for a one-category increment (none to low, low to high) were 1.55 (1.42-1.69) for type 2 diabetes, 1.56 (1.36-1.78) for post-menopausal osteoporosis, 1.05 (1.00-1.10) for hypertension, and 1.67 (1.52-1.83) for pneumonia (all p < 0.001). OCS exposure in this primary care asthma population usually continued longitudinally. Our models predict increased risk of multiple morbidities with higher projected OCS exposure. These findings support early initiation of strategies to minimise OCS use in asthma.
Prevalence, Diagnostic Utility and Associated Characteristics of Bronchodilator Responsiveness.American Journal Of Respiratory And Critical Care Medicine
Richard Beasley, Rod Hughes, Alvar Agusti, Peter Calverley, Bradley Chipps, Ricardo Del Olmo, Alberto Papi, David Price, Helen Reddel, Hana Müllerová, Eleni Rapsomaniki
Rationale: The prevalence and diagnostic utility of bronchodilator responsiveness (BDR) in a real-life setting is unclear.
Objective: To explore this uncertainty in patients aged ⩾12 years with physician-assigned diagnoses of asthma, asthma and chronic obstructive pulmonary disease (COPD), or COPD in NOVELTY, a prospective cohort study in primary and secondary care in 18 countries.
Methods: The proportion of patients with a positive BDR test in each diagnostic category was calculated using 2005 (ΔFEV1 or ΔFVC ⩾12% and ⩾200 ml) and 2021 (ΔFEV1 or ΔFVC >10% predicted) European Respiratory Society/American Thoracic Society criteria. Measurements and Main
Results: We studied 3,519 patients with a physician-assigned diagnosis of asthma, 833 with a diagnosis of asthma + COPD, and 2,436 with a diagnosis of COPD. The prevalence of BDR was 19.7% (asthma), 29.6% (asthma + COPD), and 24.7% (COPD) using 2005 criteria and 18.1%, 23.3%, and 18.0%, respectively, using 2021 criteria. Using 2021 criteria in patients diagnosed with asthma, BDR was associated with higher fractional exhaled nitric oxide; lower lung function; higher symptom burden; more frequent hospital admissions; and greater use of triple therapy, oral corticosteroids, or biologics. In patients diagnosed with COPD, BDR (2021) was associated with lower lung function and higher symptom burden.
Conclusions: BDR prevalence in patients with chronic airway diseases receiving treatment ranges from 18% to 30%, being modestly lower with the 2021 than with the 2005 European Respiratory Society/American Thoracic Society criteria, and it is associated with lower lung function and greater symptom burden. These observations question the validity of BDR as a key diagnostic tool for asthma managed in clinical practice or as a standard inclusion criterion for clinical trials of asthma and instead suggest that BDR be considered a treatable trait for chronic airway disease.
