Primary care clinicians play a key role in asthma and asthma exacerbation management worldwide because most patients with asthma are treated in primary care settings. The high burden of asthma exacerbations persists and important practice gaps remain, despite continual advances in asthma care. Lack of primary care-specific guidance, uncontrolled asthma, incomplete assessment of exacerbation and asthma control history, and reliance on systemic corticosteroids or short-acting beta2-agonist-only therapy are challenges clinicians face today with asthma care. Evidence supports the use of inhaled corticosteroids (ICS) + fast-acting bronchodilator treatments when used as needed in response to symptoms to improve asthma control and reduce rates of exacerbations, and the symptoms that occur leading up to an asthma exacerbation provide a window of opportunity to intervene with ICS. Incorporating patient perspectives and preferences when designing asthma regimens will help patients be more engaged in their therapy and may contribute to improved adherence and outcomes. This expert consensus contains 10 Best Practice Advice Points from a panel of primary care clinicians and a patient representative, formed in collaboration with the International Primary Care Respiratory Group (IPCRG), a clinically led charitable organization that works locally and globally in primary care to improve respiratory health. The panel met virtually and developed a series of best practice statements, which were drafted and subsequently voted on to obtain consensus. Primary care clinicians globally are encouraged to review and adapt these best practice advice points on preventing and managing asthma exacerbations to their local practice patterns to enhance asthma care within their practice. 

Best practice advice for asthma exacerbation prevention and management in primary care: an international expert consensus

Airsupra inhalation aerosol is a recently approved FDA medication that combines albuterol and budesonide for treating or preventing bronchoconstriction and lowering the risk of relapses in asthma patients who are 18 years of age and older. To selectively determine albuterol and budesonide in both pure and pharmaceutical dosage forms, two analytical methods were developed: the zero-order absorption method and the dual-wavelength method. Even though the two drugs absorption spectra overlapped, the distinctive peak of budesonide at the zero absorbance point of albuterol, 245 nm, allowed for direct detection of budesonide in the combination using the zero-order absorption method. The mathematical dual-wavelength method, on the other hand, allowed for the measurement of both albuterol and budesonide by choosing two wavelengths for each drug in such a way that the absorbance difference for the second drug was zero. Budesonide exhibited comparable absorbance values at wavelengths 227 and 261.40 nm; hence, these two wavelengths were utilized to identify albuterol; similarly, 221.40 and 231.20 nm were chosen to determine budesonide in their binary mixes. The methods were validated according to the ICH guideline for validation of analytical procedures Q2(R1) and demonstrated excellent linearity, sensitivity, accuracy, precision, and selectivity for determining both drugs in synthetic mixed solutions and pharmaceutical formulations. The availability of these analytical methods would be valuable for the pharmaceutical industry and regulatory authorities for quality control and assessment of pharmaceutical formulations containing albuterol and budesonide. 

Development and validation of analytical methods for selective determination of albuterol and budesonide in Airsupra inhalation aerosol using spectrophotometry

Abstract Background Asthma is a common chronic respiratory inflammatory disease that adversely affects patients’ quality of life (QoL) and overall well-being. When asthma is not adequately controlled, there is a higher risk of exacerbations and hospitalizations, thereby increasing the direct and indirect costs associated with the treatment and productivity loss. Overreliance on SABA and underutilization of ICS in the management of asthma can result in suboptimal treatment and poor asthma control. Patients who visit the emergency department are more likely to have poorly controlled asthma. Ensuring that these patients are provided with an evidence-based treatment plan during discharge can help reduce the risk of future exacerbations and consequently reduce the burden on the UAE healthcare system. Methods A joint task force comprising experts from the Emirates Society of Emergency Medicine (ESEM) and Emirates Thoracic Society (ETS) reviewed published evidence and updated guidelines in asthma management to optimize the post-discharge recommendations. Results The ESEM-ETS experts’ joint task force has developed a step-by-step plan for emergency department/hospital discharge, which is based on the GINA 2023 guideline recommendations and the medications available in the UAE. By adhering to this structured plan, emergency department physicians can play a crucial role in improving asthma care, long-term patient outcomes, and the utilization of healthcare resources. Conclusions Prioritizing patient education and ensuring patients are equipped with the best-suited asthma treatment plans prior to discharge can help ED physicians improve patient outcomes and reduce healthcare resource utilization in UAE hospitals. 

The need for implementing a standardized, evidence-based emergency department discharge plan for optimizing adult asthma patient outcomes in the UAE, expert meeting report

Short-acting β2-agonists (SABAs) treat symptoms, but not the underlying inflammation. A “window of opportunity” may exist to prevent severe exacerbations if symptoms and inflammation are treated concomitantly, as advocated by GINA and NAEPP. In the Phase 3 MANDALA study (NCT03769090), as-needed albuterol-budesonide 180/160μg FDC significantly reduced severe exacerbation risk by 27%, annualized severe exacerbation rate by 24%, and annualized total systemic corticosteroid exposure mean was reduced by 33% versus albuterol. 

Albuterol-budesonide Fixed-dose Combination (FDC) Inhaler As-needed Reduces Progression from Symptomatic Deterioration to Severe Exacerbation in Patients with Moderate-to-severe Asthma: Analysis from MANDALA

Efficacy of As-needed Use of Albuterol-Budesonide in Patients With Moderate-to-Severe Asthma Who Are Adherent to Maintenance Therapy

Background: In the MANDALA study (NCT03769090), as-needed albuterol–budesonide 180/160μg (ABD) significantly reduced severe exacerbation risk by 27% vs albuterol (A) in pts ≥12 years with moderate-to-severe asthma on ICS-containing maintenance therapy. Aim: To explore use patterns of as-needed ABD and A in MANDALA. Methods: Patterns of use of investigational product (IP) were evaluated in pts ≥12 years randomised to as-needed ABD 180/160μg (n=1013) or A 180μg (n=1014) (administered as 2 inhalations of 90/80μg and 90μg, respectively). IP use was documented in an eDiary. Results: ABD and A use patterns were similar. Mean % of days with IP use showed pts used 0–≤2 inhalations on 50–54% of days, ≤4 inhalations on 85% of days, and &gt;8 inhalations on &lt;2% of days. In the ABD and A groups, only 5.0% of pts in each group used ≥8 inhalations on ≥7 consecutive days, 2.2% and 2.3%, respectively, used 12 inhalations (max. per protocol) on ≥2 consecutive days, and 0.4% and 0.5%, respectively, used &gt;12 inhalations on ≥2 consecutive days (Table). AE frequency was comparable between treatment groups, overall and with increasing mean daily IP use (Table). The small percentage of pts using a mean of ≥6 inhalations/day of ABD (&lt;5%) had no clinically important increase in AEs vs A. Conclusions: Use patterns were similar between treatment groups indicating pts use ABD rescue in the same manner as their SABA. High daily use was uncommon. ABD was well tolerated.

Albuterol–budesonide asthma rescue inhaler: patterns of as-needed use

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Albuterol-budesonide Fixed-dose Combination (FDC) Inhaler As-needed Reduces Progression from Symptomatic Deterioration to Severe Exacerbation in Patients with Moderate-to-severe Asthma: Analysis from MANDALA

Efficacy of As-needed Use of Albuterol-Budesonide in Patients With Moderate-to-Severe Asthma Who Are Adherent to Maintenance Therapy

Albuterol–budesonide asthma rescue inhaler: patterns of as-needed use