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Data from different healthcare systems on relative cost-effectiveness of asthma step-up therapy strategies are required to inform decision-makers and clinicians. Our objective was to compare cost-effectiveness from the United Kingdom National Health Service perspective of three step-up strategies for patients with asthma uncontrolled by inhaled corticosteroid (ICS) monotherapy. This was a historical matched cohort cost-effectiveness analysis of anonymized medical records for patients with asthma of age 12–80 years. We conducted two-way comparisons of step-up therapy using increased dose (≥50%) of extrafine-particle ICS or add-on long-acting β2-agonist (LABA) via fixed-dose combination (FDC) ICS/LABA inhaler or via separate inhaler. The incremental cost-effectiveness ratio (ICER) was calculated using asthma-related direct costs during one outcome year and a composite measure of risk-domain asthma control (no asthma-related hospital attendance, acute oral corticosteroids, or consultation for lower respiratory tract infection). Patients prescribed ICS dose step-up (n= 3036) had significantly lower baseline-adjusted, mean asthma-related healthcare costs during the outcome year than those prescribed FDC ICS/LABA (n= 3036; mean difference, £124/year). ICS dose step-up had 56% probability of being less costly and marginally less effective (a trade-off), with ICER of £51,449 per additional patient controlled with FDC; and ICS dose step-up had 44% probability of being the preferred treatment strategy (less costly and more effective). In a second comparison, ICS step-up (n= 3232) had 100% probability of being cheaper and more effective than adding LABA to ICS via separate inhalers (n= 6464). For asthma step-up therapy, increasing ICS dose using extrafine-particle ICS is significantly less costly from the payer perspective and marginally (non-significantly) less effective than FDC ICS/LABA therapy containing standard fine-particle ICS. These findings apply primarily to the UK healthcare system but warrant consideration when developing guidelines in settings with strong economic constraints. ClinicalTrials.gov identifier: NCT01697722. Teva Pharmaceuticals Limited, Petach Tikva, Israel.

Volatile organic compounds (VOCs) are produced by virtually all metabolic processes of the body. As such, they have potential to serve as noninvasive metabolic biomarkers. Since exhaled VOCs are either derived from the respiratory tract itself or have passed the lungs from the circulation, they are candidate biomarkers in the diagnosis and monitoring of pulmonary diseases in particular. Good examples of the possibilities of exhaled volatiles in pulmonary medicine are provided by the potential use of VOCs to discriminate between patients with lung cancer and healthy control subjects and to noninvasively diagnose infectious diseases and the association between VOCs and markers of disease activity that has been established in obstructive lung diseases. Several steps are, however, required prior to implementation of breath-based diagnostics in daily clinical practice. First, VOCs should be studied in the intention-to-diagnose population, because biomarkers are likely to be affected by multiple (comorbid) conditions. Second, breath collection and analysis procedures need to be standardized to allow pooling of data. Finally, apart from probabilistic analysis for diagnostic purposes, detailed examination of the nature of volatile biomarkers not only will improve our understanding of the pathophysiologic origins of these markers and the nature of potential confounders but also can enable the development of sensors that exhibit maximum sensitivity and specificity toward specific applications. By adhering to such an approach, exhaled biomarkers can be validated in the diagnosis, monitoring, and treatment of patients in pulmonary medicine and contribute to the development of personalized medicine.

The particle size of inhaled corticosteroids (ICSs) may affect airway drug deposition and effectiveness.

Because randomized controlled trials of established pediatric asthma therapies are expensive and difficult to perform, observational studies may fill gaps in the evidence base.