beclometasone/formoterol / Generic mfg. - LARVOL DELTA

Deposition of three dry powder aerosol drugs in the airways of severe asthma patients undergoing biological therapy (ERS 2026) - "This study aimed to quantify the deposition patterns of the fixed‑combination dry powder inhalers Symbicort® Turbuhaler®, Foster® NEXThaler®, and Relvar® Ellipta® in the airways of these patients. Conclusions The vast majority of severe asthmatics receiving biologic therapy were able to generate inhalation parameters sufficient to achieve an adequate delivered lung dose. Overall, patients with lower PIF values through the inhaler achieved higher lung deposition with Relvar and Foster, while those with high PIF values obtained the greatest lung doses with Foster and Symbicort."

Clinical • Asthma • Immunology • Respiratory Diseases

BETRI-Prospective: Asthma Control in Single Inhaler ICS/LABA/LAMA (87/5/9 pMDI [BDP/FF/GB - 100/6/12.5 μg]) vs Single Inhaler ICS/LABA (200/6 pMDI [BDP/FF - 200/6 μg]) (clinicaltrials.gov) - P4 | N=644 | Not yet recruiting | Sponsor: Chiesi Farmaceutici S.p.A.

New P4 trial • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Lupin partners with ERN to launch Luforbec in Spain (Scanx) - "Lupin Limited has announced a strategic collaboration with LABORATORIOS ERN S.A. for the launch of Luforbec (beclometasone/formoterol) 100/6 in Spain. This fixed dose combination, delivered via a pressurized metered dose inhaler (pMDI), is intended for the regular treatment of adult asthma and chronic obstructive pulmonary disease (COPD). The partnership leverages Lupin's global respiratory expertise and ERN's established national reach to enhance access to quality respiratory care for patients across Spain."

Generic launch • Licensing / partnership • Asthma • Chronic Obstructive Pulmonary Disease • Immunology

Beclometasone/formoterol AIR-only is non-inferior to budesonide/formoterol AIR-only for exacerbation prevention in adult asthma (TSANZSRS 2026) - "BDP/FF AIR-only is non-inferior to BUD/FF AIR-only for exacerbation prevention, results in significantly lower OCS use, and has comparable outcomes for acute CVD events.Grant Support: This study was funded by Chiesi Limited, UK. No honoraria were provided to the steering committee and authors on this study."

Clinical • Asthma • Cardiovascular • Immunology • Respiratory Diseases

Beclometasone/formoterol is non-inferior to budesonide/formoterol as MART and reduces inhaler-related GHG emissions in adult asthma. (TSANZSRS 2026) - "BDP/FF-MART was non-inferior to BUD/FF-MART for severe exacerbations and asthma control and reduced the total carbon footprint of all inhaler-related GHG emissions."

Clinical • Asthma • Immunology • Respiratory Diseases

Beclometasone/Formoterol (BDP/FF) Is Non-inferior to Budesonide/Formoterol (BUD/FF) as Maintenance and Reliever Therapy (MART) and Reduces Inhaler-related GHG Emissions in Adult Asthma (ATS 2026) - No abstract available

Clinical • Asthma • Immunology • Respiratory Diseases

A clinical trial to evaluate the efficacy and safety of a mixture of allergenic extracts of D. pteronyssinus and D. farinae, in patients suffering from allergic rhinoconjunctivitis with or without controlled asthma (clinicaltrialsregister.eu) - P2/3 | N=320 | Not yet recruiting | Sponsor: LETI Pharma S.L.U.

New P2/3 trial • Asthma • Conjunctivitis • Immunology • Ocular Infections • Ocular Inflammation • Ophthalmology • Pulmonary Disease • Respiratory Diseases

Clinical effectiveness of anti-inflammatory reliever therapies (AIR) for exacerbation prevention: a non-inferiority study (BTS WM 2025) - "We conducted a non-inferiority study (pre-specified 20% non-inferiority margin; IRR 1.20) for exacerbation prevention of BDP-F (Fostair) AIR compared with BUD-F (Symbicort) AIR. Incidence of CVD events post-initiation of AIR was similar for both groups: IRR=1.04 for BDP-F vs BUD-F [0.46,2.34]). BDP-F AIR is non-inferior to BUD-F AIR for exacerbation prevention, results in significantly lower OCS use, and has comparable outcomes for acute cardiovascular events."

Clinical • Head-to-Head • Asthma • Cardiovascular • Immunology • Respiratory Diseases

Feasibility of a digital-first approach to inhaler optimisation in asthma care: supporting net zero NHS goals (BTS WM 2025) - "Aims To evaluate the feasibility and patient engagement of a digital-first, population health-led approach to inhaler optimisation, supporting low-risk asthma patients to switch from Fostair 100/6 MDI to Fobumix Easyhaler DPI...Strong uptake and willingness to switch highlight the model's potential for scalable implementation across primary care. It supports environmentally sustainable prescribing in line with NHS Net Zero priorities, while preserving clinical safety and patient choice."

Alzheimer's Disease • Asthma • CNS Disorders • Dementia • Immunology • Respiratory Diseases

Relative lung availability and total systemic exposure after inhalation of medium or high strength doses of beclometasone dipropionate/formoterol fumarate, formulated as pMDI with a next generation propellant (BTS WM 2025) - "A new formulation of CHF1535 [beclometasone dipropionate (BDP)/formoterol fumarate (FF)] 100/6 µg medium strength (MS) and 200/6 µg high strength (HS) has been developed with HFA-152a...No safety signals were observed. Conclusions Therapeutic equivalence between the two formulations was demonstrated, supporting the timely introduction of therapeutic options enabling a seamless transition for patients, while minimizing climate impact."

Asthma • Chronic Obstructive Pulmonary Disease • Immunology • Respiratory Diseases

Improved lung function with beclomethasone/formoterol versus beclomethasone alone in asthma: The FORCE2 study. (PubMed, J Asthma) - P3 | "The primary and the key secondary objectives were met, with BDP/FF vs. BDP adjusted mean differences of 104 (95% confidence interval 61, 148) mL and 124 (76, 173) mL for FEV1 AUC0-12h and peak FEV1 at Week 12, respectively (p < 0.001 for both). A similar proportion of patients experienced adverse events in the two treatment groups (26.9% vs. 26.4%), with most events mild or moderate in severity and not considered related to study drug.ConclusionsThe study met its aims, demonstrating the contribution of FF to BDP in lung function improvement, with both treatments being well tolerated.ClinicalTrials.gov NCT05292586."

Journal • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Extrafine beclometasone/formoterol is non-inferior to budesonide/formoterol as maintenance and reliever therapy (MART) for adult asthma patients and reduces the total carbon footprint of all inhaler-related greenhouse gas (GHG) emissions. (ERS 2025) - "To investigate non-inferiority of Fostair MART (BDP/FF-MART) compared to Symbicort MART (BUD/FF-MART) for exacerbation prevention and asthma control, and the carbon footprint of inhalers after initiation of BDP/FF-MART. As-needed SABA accounted for 34-54% of this reduction. BDP/FF-MART was non-inferior to BUD/FF-MART for severe exacerbations and asthma control and reduced the total carbon footprint of all inhaler-related GHG emissions."

Clinical • Asthma • Immunology • Respiratory Diseases

Impact of smoking on asthma control with extrafine beclomethasone/formoterol: post hoc analysis of a prospective cohort study. (PubMed, J Asthma) - "Uncontrolled asthma remained infrequent but was more prevalent in current (10%) and former (8.9%) smokers than in nonsmokers (5.7%) (p = 0.002 and p = 0.033, respectively).ConclusionsAsthma patients, regardless of smoking status, demonstrate a similar response to treatment. Uncontrolled asthma, though rare under treatment, is more common among smokers, due to their higher baseline severity."

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

TEACH: The Importance of Tailored Education And Device Handling for Asthmatic Patients (clinicaltrials.gov) - P=N/A | N=250 | Not yet recruiting | Sponsor: Chiesi Hungary Ltd.

New trial • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

FORCE2: A Study Testing the Superiority of CHF 1535 pMDI 800/24µg Total Daily Dose Compared to CHF 718 pMDI 800µg Total Daily Dose in Adults With Asthma on Medium or High-Dose Inhaled Corticosteroid (clinicaltrials.gov) - P3 | N=1377 | Completed | Sponsor: Chiesi Farmaceutici S.p.A. | N=610 ➔ 1377

Enrollment change • Head-to-Head • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Evaluating the impact of changing inhaler color on perception of symptoms and disease burden in patients with asthma: The FEEL study. (PubMed, J Asthma) - "Perceived improvements were lower than expected with both, numerically favoring the pink inhaler (mean VAS 41.1 vs. 44.6); 46.6% believed a change had been made, 51.9% of whom believed this impacted symptoms.ConclusionsChanging inhaler color had no impact on asthma symptoms, but did have a numerical impact on patients' expectations of subsequent treatment effect. This emphasizes the importance of communication between patients and healthcare practitioners when changing inhalers."

Journal • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Particularities of deposition of two ICS-LABA fixed dose combination dry powder aerosol drugs in the airways of COPD patients. (PubMed, Respir Med) - "Exacerbating patients had lower lung doses (28.8±5.8% for Foster® NEXThaler® and 23.7±3.8% for Relvar® Ellipta®) than their non-exacerbating counterparts (33.7±6.1% for Foster® NEXThaler® and for 24.9±3.9% for Relvar® Ellipta®). The exact clinical consequences of the differences between the deposition distributions of the two drugs could be assessed only by systematic clinical trials."

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

MiSTIC: Step-up to Medium Strength Triple Therapy vs High Strength ICS/LABA in Adult Asthmatics Uncontrolled on Medium Strength ICS/LABA (clinicaltrials.gov) - P4 | N=320 | Terminated | Sponsor: Chiesi Farmaceutici S.p.A. | Active, not recruiting ➔ Terminated; The study was prematurely stopped due to extensive challenges in patient recruitment. The Sponsor issued a notification of early study termination to all investigational sites and all external stakeholders.

Combination therapy • Trial termination • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

FORCE2: A Study Testing the Superiority of CHF 1535 pMDI 800/24µg Total Daily Dose Compared to CHF 718 pMDI 800µg Total Daily Dose in Adults With Asthma on Medium or High-Dose Inhaled Corticosteroid (clinicaltrials.gov) - P3 | N=610 | Completed | Sponsor: Chiesi Farmaceutici S.p.A. | Active, not recruiting ➔ Completed | Trial completion date: Feb 2025 ➔ Jun 2024

Head-to-Head • Trial completion • Trial completion date • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

FORCE2: A Study Testing the Superiority of CHF 1535 pMDI 800/24µg Total Daily Dose Compared to CHF 718 pMDI 800µg Total Daily Dose in Adults With Asthma on Medium or High-Dose Inhaled Corticosteroid (clinicaltrials.gov) - P3 | N=610 | Active, not recruiting | Sponsor: Chiesi Farmaceutici S.p.A. | Trial primary completion date: Nov 2024 ➔ Jun 2024

Head-to-Head • Trial primary completion date • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

FORCE2: A Study Testing the Superiority of CHF 1535 pMDI 800/24µg Total Daily Dose Compared to CHF 718 pMDI 800µg Total Daily Dose in Adults With Asthma on Medium or High-Dose Inhaled Corticosteroid (clinicaltrials.gov) - P3 | N=580 | Active, not recruiting | Sponsor: Chiesi Farmaceutici S.p.A. | Trial completion date: Oct 2024 ➔ Feb 2025 | Trial primary completion date: Jul 2024 ➔ Nov 2024

Head-to-Head • Trial completion date • Trial primary completion date • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

FORCE2: A Study Testing the Superiority of CHF 1535 pMDI 800/24µg Total Daily Dose Compared to CHF 718 pMDI 800µg Total Daily Dose in Adults With Asthma on Medium or High-Dose Inhaled Corticosteroid (clinicaltrials.gov) - P3 | N=580 | Active, not recruiting | Sponsor: Chiesi Farmaceutici S.p.A. | Trial completion date: Jun 2024 ➔ Oct 2024

Head-to-Head • Trial completion date • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

FORCE2: A Study Testing the Superiority of CHF 1535 pMDI 800/24µg Total Daily Dose Compared to CHF 718 pMDI 800µg Total Daily Dose in Adults With Asthma on Medium or High-Dose Inhaled Corticosteroid (clinicaltrials.gov) - P3 | N=580 | Active, not recruiting | Sponsor: Chiesi Farmaceutici S.p.A. | Recruiting ➔ Active, not recruiting | Trial completion date: Oct 2023 ➔ Jun 2024 | Trial primary completion date: Oct 2023 ➔ Jun 2024

Enrollment closed • Head-to-Head • Trial completion date • Trial primary completion date • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

FEEL: Study in Adult Patients With Moderate to Severe Asthma (clinicaltrials.gov) - P3 | N=78 | Completed | Sponsor: Chiesi Farmaceutici S.p.A. | Active, not recruiting ➔ Completed

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

MiSTIC: Step-up to Medium Strength Triple Therapy vs High Strength ICS/LABA in Adult Asthmatics Uncontrolled on Medium Strength ICS/LABA (clinicaltrials.gov) - P4 | N=320 | Active, not recruiting | Sponsor: Chiesi Farmaceutici S.p.A. | Recruiting ➔ Active, not recruiting | N=1400 ➔ 320 | Trial completion date: Jul 2024 ➔ Apr 2024 | Trial primary completion date: Jul 2024 ➔ Apr 2024

Combination therapy • Enrollment change • Enrollment closed • Trial completion date • Trial primary completion date • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases