Airsupra (budesonide/salbutamol) / AstraZeneca, Avillion - LARVOL DELTA

AIRSA001: Anti-Inflammatory Reliever South Africa (clinicaltrials.gov) - P3 | N=1038 | Enrolling by invitation | Sponsor: University of KwaZulu | Not yet recruiting ➔ Enrolling by invitation

Enrollment open • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Efficacy of As-needed Albuterol‒Budesonide Versus Albuterol on Systemic Corticosteroid Exposure in Participants With Mild Asthma: BATURA Prespecified Analysis (ATS 2025) - No abstract available

Clinical • Asthma • Immunology • Respiratory Diseases

Can a New Portable Valved Holding Chamber (VHC) for Use on the Go Improve the Delivery and Reduce Side Effects of a New Combination Albuterol/Budesonide Inhaler? (ATS 2025) - No abstract available

Adverse events • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Baseline Characteristics of Patients With Asthma Initiating Albuterol-Budesonide Rescue: A Real-world US Claims-based Study (ATS 2025) - No abstract available

Clinical • Real-world • Real-world evidence • Asthma • Immunology • Respiratory Diseases

Corticosteroid-associated Systemic Adverse Events in Patients on Background Inhaled Corticosteroid Maintenance Therapy and Taking Albuterol-Budesonide Versus Albuterol as Rescue: Post-hoc Analysis of MANDALA (ATS 2025) - No abstract available

Adverse events • Clinical • Retrospective data • Asthma • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Albuterol-Budesonide Treatment in Acute Airway Obstruction: Patient Selection for the ALTA Study (ATS 2025) - No abstract available

Clinical • Asthma • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Airway Inflammation and Asthma Control in Patients With Moderate Asthma Using Salbutamol or Budesonide/Formoterol Reliever: A Randomized, Controlled, Open-label Study (ATS 2025) - No abstract available

Clinical • Asthma • Immunology • Inflammation • Respiratory Diseases

As-needed Albuterol-budesonide Decreases Risk of Severe Asthma Exacerbation in the First Three Months Post-randomization Compared to As-needed Albuterol in Patients Treated for Moderate-to-Severe Asthma: MANDALA Post-Hoc Analysis (ATS 2025) - No abstract available

Clinical • Retrospective data • Asthma • Immunology • Respiratory Diseases

Effects on Morning Trough Lung Function with Four Times Daily Use of Albuterol-Budesonide Versus Albuterol Over 1 Weeks' Time: Results from the DENALI Study (AAAAI-WAO 2025) - "Conclusions Four times daily albuterol-budesonide versus albuterol over 1 week resulted in significantly improved morning trough lung function; albuterol or budesonide alone did not differ from placebo. These observations are relevant for the time surrounding exacerbations when frequent rescue use occurs."

Asthma • Immunology • Respiratory Diseases

Efficacy Of As-needed Albuterol‒Budesonide Versus Albuterol By Baseline Therapy In Participants With Mild Asthma: BATURA Pre-specified Analysis (AAAAI-WAO 2025) - P3 | "Similarly, ALB-BUD reduced annualized severe exacerbation rate, versus ALB, in the SABA-alone (rate ratio [RR] 0.38, 95% CI 0.26, 0.56) and SABA+maintenance subgroups (RR 0.77, 95% CI 0.43, 1.38). Conclusions In participants with mild asthma in BATURA, ALB-BUD significantly reduced the risk of a severe exacerbation in those receiving SABA-alone and showed a trend in risk reduction in those on maintenance therapy."

Clinical • Late-breaking abstract • Asthma • Immunology • Respiratory Diseases

PT027 Compared to PT007 in Patients With Asthma With Mannitol-induced Acute Airway Obstruction (clinicaltrials.gov) - P3 | N=21 | Completed | Sponsor: AstraZeneca | Recruiting ➔ Completed | N=105 ➔ 21

Enrollment change • Trial completion • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Severe pneumonia caused by Elizabethkingia anophelis combined with Acinetobacter baumannii infection: a case report. (PubMed, Am J Transl Res) - "He was discharged from the hospital after being given cefoperazone sulbactam sodium and minocycline, as well as nebulized inhalation of chymotrypsin, salbutamol, and budesonide to assist ventilation. This article summarizes the diagnosis and treatment of this patient in order to share the experience of the subsequent treatments."

Journal • Infectious Disease • Novel Coronavirus Disease • Pneumonia • Respiratory Diseases

ARRIVAL: Open-label Study to Assess Reduction of Background Asthma Medication While Sustaining Asthma Control and Clinical Remission With Tezepelumab in Patients 12-80yrs With Severe Asthma. (clinicaltrials.gov) - P3 | N=300 | Recruiting | Sponsor: AstraZeneca | Not yet recruiting ➔ Recruiting

Enrollment open • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Distinguished Industry & Late-breaking Oral Abstracts - Session 2 (ACAAI 2024) - "Learning Objectives Objective 1: Observe that dupilumab reduced severe exacerbations in children with moderate-to-severe type 2 asthma, irrespective of evidence of allergic asthma for up to 104 weeks...Discuss achievement of stringent itch reduction targets with tapinarof cream 1% once daily compared with vehicle cream in two phase 3 trials in adults and children with atopic dermatitis...Describe the impact of treatment with roflumilast cream 0.15% in patients with mild or moderate atopic dermatitis, including changes in the disease's impact on family and caregivers. Objective 3: Compare the effects of as-needed albuterol–budesonide 180/160 µg vs albuterol 180 µg on severe asthma exacerbation risk and safety in patients aged =12 years with mild asthma. Consider nirsevimab for the prevention of RSV lower respiratory tract disease in both inpatient and outpatient settings. Upon completion of this session, clinicians should be able to proficiently communicate..."

Late-breaking abstract • Asthma • Atopic Dermatitis • Chronic Rhinosinusitis With Nasal Polyps • Dermatitis • Dermatology • Immunology • Respiratory Diseases • Respiratory Syncytial Virus Infections

BATURA: A Fully Virtual Randomized Controlled Study of As-Needed Albuterol-Budesonide versus Albuterol in Mild Asthma (ACAAI 2024) - P3 | "The BATURA study enrolled 2421 participants (1209 randomized to ALB-BUD and 1212 to ALB); the mean (SD) age was 42.7 (14.50) years; 2.8% were 12 to 17 years old and 68.3% female. Compared with ALB, ALB-BUD reduced severe exacerbation risk by 47% in a time-to-first-severe-exacerbation analysis (hazard ratio = 0.535, 95% CI: 0.392-0.730, P < .001). Similar percentages of participants experienced adverse events in both groups (Table 1)."

Clinical • Late-breaking abstract • Asthma • Immunology • Respiratory Diseases

EFFECTS OF AS-NEEDED ALBUTEROLBUDESONIDE VERSUS ALBUTEROL ON ASTHMA EXACERBATIONS AND LUNG FUNCTION BY BASELINE OBSTRUCTION (ACAAI 2024) - P3 | "As-needed albuterol-budesonide vs albuterol reduced severe exacerbation risk and improved lung function for patients with moderate-to-severe asthma, including those with baseline postbronchodilator airflow obstruction. 1A. Time to first severe exacerbation by baseline post-bronchodilator FEV1/FVC."

Asthma • Immunology • Respiratory Diseases

PATTERNS OF AS-NEEDED USE OF ALBUTEROL-BUDESONIDE OR ALBUTEROL AROUND A SEVERE EXACERBATION: MANDALA POST-HOC ANALYSIS (ACAAI 2024) - P3 | "In MANDALA, patients receiving albuterol-budesonide rescue tended to use fewer as-needed inhalations in the 15 days before and after a severe exacerbation than those receiving albuterol Daily as-needed study medication use for 15 days before and after the first day of the first severe asthma exacerbation (Day 0), and in non-exacerbating patients"

Retrospective data • Asthma • Immunology • Respiratory Diseases

INPATIENT USE OF BENRALIZUMAB IN ACUTE SEVERE EOSINOPHILIC ASTHMA (CHEST 2024) - "Because T2 inflammation involves cytokines such as IL-4, 5, and 13, biologics like pascolizumab, benralizumab, and lebrikizumab respectively have been used as corticosteroid-sparing therapeutics [1]...Four months later, despite compliance with his inhaler regimen, he presented to the emergency department with worsening shortness of breath shortly after treatment with a one-time injection of triamcinolone and as-needed salbutamol-budesonide by his primary care physician... Uncontrolled eosinophilic asthma can be a challenging entity to manage leading to prolonged hospital stays and high corticosteroid burden. Here, we highlight how benralizumab was used to treat an acute exacerbation in an effective and timely manner thus warranting further study."

Clinical • Asthma • Cardiovascular • Cough • Eosinophilia • Hypertension • Immunology • Infectious Disease • Inflammation • Novel Coronavirus Disease • Pulmonary Disease • Respiratory Diseases • IL4

DARWIN: Study to Investigate Changes in Airway Inflammation, Symptoms, and Rescue Therapy Utilization With AIRSUPRA Compared to Albuterol as Needed in Adults With Mild Asthma (clinicaltrials.gov) - P4 | N=100 | Recruiting | Sponsor: AstraZeneca | Not yet recruiting ➔ Recruiting

Enrollment open • Asthma • Immunology • Inflammation • Pulmonary Disease • Respiratory Diseases

LESSONS FROM BENCH TO BEDSIDE: EXPLORING GENOMIC AND NONGENOMIC MECHANISMS OF ALBUTEROL-BUDESONIDE AS NEEDED FOR TREATMENT AND PREVENTION OF ACUTE AIRWAY OBSTRUCTION (ALTA) (CHEST 2024) - P3 | "While there is in vitro understanding of the mechanisms by which a fast-acting beta2-agonist and ICS may interact to effect bronchoconstriction and airway inflammation, ALTA is the first study to explore potential in vivo inflammatory and genomic mechanisms of SABA-ICS in the treatment and prevention of acute airway obstruction on lung function, symptoms, airway hyperresponsiveness, and airway inflammation. CLINICAL IMPLICATIONS: ALTA will provide patient-based, mechanistic data across asthma endotypes that will inform decisions by practicing clinicians to use combination rescue therapy."

Asthma • Immunology • Inflammation • Respiratory Diseases

INSIGHTS INTO SURFACTANT PROTEIN C DEFICIENCY: A CASE STUDY OF AN INFANT WITH THE C.565T>G (P.CYS189GLY) MUTATION (CHEST 2024) - "Budesonide, albuterol, and hypertonic saline treatments were prescribed prior to discharge...The patient was treated with steroids and azithromycin for anti-inflammatory effect prior to obtaining open lung biopsy...Current clinical considerations are long-term treatment with steroids and/or hydroxychloroquine... While c.565T>G (p.Cys189Gly) is reported as a variant of uncertain significance, our patient has clinical and pathological findings consistent with a surfactant protein deficiency leading us to conclude that this variant likely has clinical significance."

Case study • Clinical • Surfactant • Acute Respiratory Distress Syndrome • Fibrosis • Immunology • Inflammation • Interstitial Lung Disease • Pulmonary Disease • Respiratory Diseases • SFTPC

ACHALASIA: UNUSUAL CAUSE OF COUGH IN CHILDREN (CHEST 2024) - "He was also started on inhaled albuterol and budesonide medications with no response... Early diagnosis and surgical oesophagomyotomy leads to a successful outcome."

Clinical • Chronic Cough • Cough • Gastroesophageal Reflux Disease • Gastrointestinal Disorder • Infectious Disease • Pain • Rare Diseases • Respiratory Diseases

EFFICACY OF ALBUTEROL-BUDESONIDE RESCUE ON TOP OF INHALED CORTICOSTEROID/LONG-ACTING β-AGONIST (LABA) ASTHMA MAINTENANCE THERAPY CONTAINING FORMOTEROL OR OTHER LABA (MANDALA) (CHEST 2024) - No abstract available

Clinical • Asthma • Immunology • Respiratory Diseases

EFFICACY OF ALBUTEROL-BUDESONIDE RESCUE IN PATIENTS WITH MODERATE-TO-SEVERE ASTHMA BY SMOKING HISTORY (FORMER VS NEVER): ANALYSIS OF MANDALA (CHEST 2024) - P3 | "Compared to as-needed albuterol, as-needed albuterol-budesonide reduced the risk of severe exacerbations and mean annualized total SCS exposure in former smokers to a comparable degree as those of never smokers. Limitations of this analysis include the relatively small number of former smokers included (n=405) and subsequent lack of statistical power for subgroup analyses. CLINICAL IMPLICATIONS: While ICS therapy has been reported to be less effective in former smokers with asthma, as-needed albuterol-budesonide appears to be effective in reducing exacerbations and SCS use in these patients."

Clinical • Asthma • Immunology • Respiratory Diseases • Tobacco Cessation

AIRSUPRA (albuterol/budesonide) demonstrated statistically significant and clinically meaningful reduction in the risk of severe exacerbations in patients with intermittent or mild persistent asthma in BATURA Phase III trial (Businesswire) - P3 | N=2,517 | BATURA (NCT05505734) | Sponsor: Bond Avillion 2 Development LP | "Positive high-level results from the BATURA Phase IIIb trial showed AstraZeneca’s AIRSUPRA (albuterol/budesonide) met the primary endpoint, demonstrating a statistically significant and clinically meaningful reduction in the risk of a severe exacerbation when used as an as-needed rescue medication in response to symptoms compared to as-needed albuterol. The trial included patients with intermittent or mild persistent asthma, including those on short-acting beta2-agonist (SABA) alone, low-dose inhaled corticosteroid (ICS) maintenance therapy, or leukotriene receptor antagonist (LTRA) maintenance therapy...The safety and tolerability of AIRSUPRA in the BATURA trial was consistent with its established profile and no new safety concerns were reported....Independent Data Monitoring Committee recommended trial stop early due to overwhelming efficacy at pre-planned analysis"

P3 data • Asthma