fluticasone propionate/salmeterol xinafoate inhalation powder / Generic mfg. - LARVOL DELTA

Evaluating Satisfaction and Quality of Life with Elpenhaler: A Pooled Analysis of Real-Life Studies. (PubMed, Pragmat Obs Res) - "Individual participant data were pooled from seven real-life studies of fixed-dose combinations delivered via the Elpenhaler device (asthma, budesonide/formoterol: BOREAS, SKIRON, COMPLETE, NOTOS; COPD, salmeterol/fluticasone: AEOLOS, AHEAD, RETRIEVE)...Treatment delivered via the Elpenhaler is associated with high patient satisfaction and with significant and sustained improvements in quality of life, supporting its effectiveness in real-world respiratory care. The identification of factors associated with satisfaction and quality of life improvement may help in personalising treatment and optimising care."

HEOR • Journal • Retrospective data • Asthma • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Repeated bronchoscopies in an asthma trial: multi-disciplinary (nursing, physician, scientist) experience of four procedures per subject over 6 weeks (ERS 2026) - P4 | "MAELABA RBs were performed at 2-week intervals: at baseline, and after 2 weeks each of salmeterol monotherapy, a washout period, and salmeterol-fluticasone combination therapy, to assess β2-agonist effects on gene expression...All were pre-treated with nebulised ipratropium bromide and recovered safe for discharge within 2 hours...One RB-related adverse event was recorded (chest pain without pathology) requiring emergency assessment but not hospital admission. Conclusions Repeated lower airway sampling during an asthma clinical trial was safe, well tolerated, and provided reliable, high quality airway samples."

Clinical • Asthma • Immunology • Respiratory Diseases

In vitro performance of valved holding chambers in paediatric asthma controller therapy (ERS 2026) - "Study design: This in vitro study evaluated the fine particle dose in the 1-5 µm range (FPD1-5µm) of fluticasone propionate/salmeterol combination-inhaler, fluticasone propionate mono-inhaler, and ciclesonide delivered via three VHCs: AeroChamber Plus Flow-Vu® (AC), EasyChamber® (EC), and OptiChamber Diamond® (OD)... There were notable differences in the in vitro performance between the tested VHCs and pMDIs. Ciclesonide exhibited more favourable aerodynamic properties than fluticasone propionate either from the mono- or combination-inhaler. Our findings underline the importance of evidence-based device selection in optimizing controller therapy in children."

Preclinical • Asthma • Immunology • Pediatrics • Respiratory Diseases

Lannett Company LLC, a wholly owned subsidiary of Aurobindo Pharma USA, Inc., has launched the generic equivalent of Advair Diskus (fluticasone propionate and salmeterol inhalation powder), a product of GSK plc, in the US market. (ExpressPharma) - "The product has been launched in 100/50 mcg and 250/50 mcg strengths....Advair Diskus in combination therapy is indicated for the treatment of asthma and chronic obstructive pulmonary disease (COPD)."

Generic launch • Asthma • Chronic Obstructive Pulmonary Disease • Immunology

A Study to Evaluate the Efficacy and Safety of QVM149 (Indacaterol Acetate / Glycopyrronium Bromide / Mometasone Furoate) Versus Salmeterol Xinafoate/Fluticasone Propionate in Children From 12 Years to Less Than 18 Years of Age With Asthma. (clinicaltrials.gov) - P3 | N=188 | Recruiting | Sponsor: Novartis Pharmaceuticals | Not yet recruiting ➔ Recruiting

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

Real-World Comparison of Inhaled Corticosteroid Monotherapy versus Fixed-Dose Inhaled Corticosteroid-Long-Acting Beta-2 Agonist Combinations in Children Aged 6-11 Years with Persistent Asthma. (PubMed, J Asthma) - "A total of 296 children aged 6-11 years with persistent asthma met the inclusion criteria: 184 received fluticasone propionate (FP), 47 received fluticasone propionate/salmeterol (FP/SAL) and 65 received budesonide/formoterol (BUD/FOR)...Rates of emergency department visits and hospital admissions were also comparable between groups (p = 0.805 and p = 0.383, respectively), and no significant differences were found regarding systemic corticosteroid-requiring asthma exacerbations. In children aged 6-11 years with persistent asthma, no single controller therapy demonstrated clear superiority in preventing asthma exacerbations."

Journal • Monotherapy • Real-world evidence • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Cipla has received approval from the U.S. Food and Drug Administration (U.S. FDA) for its abbreviated new drug application (ANDA) for generic Advair Diskus (fluticasone propionate and salmeterol inhalation powder) in three strengths — 100/50 mcg, 250/50 mcg, and 500/50 mcg . (The Hindu) - "The product is expected to be launched in the second quarter (Q2) of FY27 in the U.S., the company said on Monday."

ANDA • Generic launch • Asthma • Chronic Obstructive Pulmonary Disease • Immunology

A Study to Evaluate the Efficacy and Safety of QVM149 (Indacaterol Acetate / Glycopyrronium Bromide / Mometasone Furoate) Versus Salmeterol Xinafoate/Fluticasone Propionate in Children From 12 Years to Less Than 18 Years of Age With Asthma. (clinicaltrials.gov) - P3 | N=188 | Not yet recruiting | Sponsor: Novartis Pharmaceuticals | N=304 ➔ 188 | Trial completion date: Dec 2029 ➔ Jan 2029

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

Inhaled Corticosteroids Influence Pulmonary Microbiota in Severe Equine Asthma. (PubMed, Animals (Basel)) - "Twelve horses in exacerbation received long-acting β2-agonist (LABA, salmeterol) or ICs/LABA (fluticasone/salmeterol) by inhalation, for 2 weeks...However, it is not clear if these changes are positive or detrimental to the lung environment. Furthermore, lung function following treatment was not perfectly identical between groups."

Journal • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Effectiveness and Safety of Budesonide/Formoterol in Asthma: A Systematic Review. (PubMed, Healthcare (Basel)) - "B/F MART significantly delayed the first SE and reduced annual rates versus Budesonide + SABA (HR = 0.57; RR = 0.55), B/F + SABA (HR = 0.62; RR = 0.58), and Fluticasone/Salmeterol + SABA (HR = 0.75; RR = 0.72)...However, limited trial data leave the evidence for maintenance or reliever regimens controversial. Across all regimens, B/F is well-tolerated within 6 to 12 months."

Journal • Review • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Assessment of the efficacy and medication adherence of fluticasone propionate-salmeterol combination delivered via a capsule-based dry powder inhaler in asthmatic patients. (PubMed, Allergol Immunopathol (Madr)) - "This study demonstrates that fluticasone-salmeterol capsule inhaler therapy can significantly improve symptom control and respiratory function in adult asthma patients."

Journal • Observational data • Retrospective data • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

AIRLYMPUS: Study of Lunsekimig (SAR443765) Compared With Placebo in Adults With High-risk Asthma (clinicaltrials.gov) - P2 | N=556 | Active, not recruiting | Sponsor: Sanofi | Recruiting ➔ Active, not recruiting | N=1147 ➔ 556

Enrollment change • Enrollment closed • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Direct healthcare cost comparison of fluticasone/salmeterol and budesonide/formoterol maintenance and reliever therapy for moderate to severe asthma in the South African public sector. (PubMed, Afr J Thorac Crit Care Med) - "Bud/form's price sensitivity presents opportunities for strategic procurement. However, further comprehensive real-world economic evaluations across all asthma severities remain essential to guide evidence-informed, context specific policy decisions."

HEOR • Journal • Reimbursement • US reimbursement • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Drug-related pulmonary fibrosis: A real-world pharmacovigilance study of the FDA Adverse Event Reporting System. (PubMed, Medicine (Baltimore)) - "Four cardiovascular system drugs (12.12%) included amiodarone (ROR = 41.92), dronedarone (ROR = 10.25), and simvastatin (ROR = 6.94). Four respiratory system drugs (12.12%) included indacaterol (ROR = 6.87), salmeterol/fluticasone (ROR = 4.30), and olodaterol (ROR = 3.76). Four antipathogenic microbial drugs (12.12%) included nitrofurantoin (ROR = 22.92), sulfasalazine (ROR = 5.69), and hydroxychloroquine (ROR = 3.51). Six other drugs (18.18%) included iodine-131 (ROR = 19.72), calcium carbonate (ROR = 8.59), and tamsulosin (ROR = 7.48)...The 3 drugs associated with the greatest PF risk were amiodarone, bleomycin, and nitrofurantoin. These findings highlight potential pharmacovigilance signals that warrant clinical vigilance and further validation through prospective studies."

Adverse events • Journal • Real-world evidence • Cardiovascular • Cough • Immunology • Oncology • Pulmonary Disease • Respiratory Diseases

CQVM149C2301: A double-dummy, double-blind, randomized, active controlled, two-way cross-over study with 12-week treatment duration per period, to evaluate the efficacy and safety of QVM149 (indacaterol acetate / glycopyrronium bromide / mometasone furoate) compared to salmeterol xinafoate/fluticasone propionate in children from 12 years to less than 18 years of age with asthma. (clinicaltrialsregister.eu) - P2/3 | N=37 | Not yet recruiting | Sponsor: Novartis Pharma AG

New P2/3 trial • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

In Vitro Performance of Valved Holding Chambers in Paediatric Asthma Controller Therapy. (PubMed, Acta Paediatr) - "There were notable differences between the tested VHC's drug delivery. Ciclesonide exhibited favourable aerodynamic properties than fluticasone."

Journal • Preclinical • Asthma • Immunology • Pediatrics • Pulmonary Disease • Respiratory Diseases

Effects of Inhaled Corticosteroids and Long-Acting β2-Agonists on Efferocytosis and Inflammatory Cell Survival: An In Vitro Study Relevant to COPD and Lung Cancer. (PubMed, Int J Mol Sci) - "Apoptosis was induced in Jurkat T cells by UV irradiation (100 mJ/cm2) and in murine thymocytes by dexamethasone (1 µM, 4 h); apoptotic and necrotic populations were characterized by annexin-V/propidium iodide and Sytox Green/Hoechst H-33342 staining...Neither fluticasone nor salmeterol, individually or in combination, significantly altered efferocytic capacity in any phagocyte tested (all ANOVA p > 0.26). Fluticasone (10-8 and 10-6 M) significantly improved 24 h neutrophil survival and reduced early apoptosis (p < 0.05) but did not translate this survival benefit into enhanced efferocytosis. Salmeterol was cytotoxic at 10-4 M and inactive at 10-8-10-6 M. These findings indicate that the established anti-inflammatory benefits of ICS/LABA in COPD do not extend to augmentation of efferocytosis in this acute, serum-free in vitro setting and that pharmacological restoration of efferocytosis in COPD-a defect implicated in the pathogenesis and progression of..."

Journal • Preclinical • Chronic Obstructive Pulmonary Disease • Immunology • Lung Cancer • Oncology • Pulmonary Disease • Respiratory Diseases • Solid Tumor • ANXA5 • MERTK

AIRLYMPUS: Study of Lunsekimig (SAR443765) Compared With Placebo in Adults With High-risk Asthma (clinicaltrials.gov) - P2 | N=1147 | Recruiting | Sponsor: Sanofi | N=673 ➔ 1147

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

Clinical efficacy of Chaipu Decoction combined with Seretide in the treatment of bronchial asthma and its impact on TNF-α and CD4+/CD8. (PubMed, Sci Rep) - No abstract available

Journal • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases • CD4 • TNFA

Fluticasone- vs Budesonide-Based Dual Therapy for COPD. (PubMed, JAMA Netw Open) - "In this cohort study of new ICS-LABA users with COPD, once-daily dry powder fluticasone furoate-vilanterol inhalers were associated with slightly improved clinical outcomes compared with twice-daily metered-dose budesonide-formoterol inhalers and twice-daily dry powder fluticasone propionate-salmeterol inhalers. Further studies are needed to explore potential intraclass differences among inhalers used to treat COPD."

Clinical • Journal • Chronic Obstructive Pulmonary Disease • Immunology • Infectious Disease • Pneumonia • Pulmonary Disease • Respiratory Diseases

Single vs Dual Lactose-Polyethylene Glycol 3000 Microcarrier Systems for Pulmonary Salmeterol and Fluticasone Targeted Delivery. (PubMed, Drug Des Devel Ther) - "Dual-microcarrier increased pulmonary drug retention with a marginal rise in systemic drug levels and reduced inflammatory lymphocytes/eosinophils/neutrophils infiltration, IL-4/5/9/13 release, mucus production, and bronchoconstriction. Dual-microcarrier is more efficient than single-microcarrier in pulmonary SX/FP delivery."

Journal • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases • IL4

CLI-05993AA5-06: A 52 week study in which neither Sponsor or participant know the treatment assigned to subjects to compare the experimental drug (CHF 5993) with a commercial drug (Seretide Evohaler) in adolescent subjects with treated uncontrolled asthma (clinicaltrialsregister.eu) - P2/3 | N=147 | Not yet recruiting | Sponsor: Chiesi Farmaceutici S.p.A.

New P2/3 trial • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Economic evaluation of single-inhaler triple therapy for chronic obstructive pulmonary disease in Thailand. (PubMed, BMJ Open Respir Res) - "Our study indicated that SITTs are not cost-effective at the current price compared with the current MITT for COPD treatment. However, FF/UMEC/VI could be a promising option, with an approximately 30% price reduction."

Clinical • HEOR • Journal • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Disproportionate increase in COPD exacerbation risk for 3 months after discontinuing LAMA or ICS: insights from the FLAME trial. (PubMed, Thorax) - P3 | "Our findings suggest potent LAMA and ICS treatment withdrawal effects on exacerbations, highlighting the importance of treatment adherence and accounting for withdrawal effects in clinical trials."

Journal • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Clinician Views on Inhaler Substitution in the Veterans Health Administration. (PubMed, Chest) - "VHA clinicians reported predominantly negative perceptions of the 2021 inhaler formulary change, underscoring the importance of timely clinician communication, patient education, and specialty engagement in future formulary transitions."

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