beclometasone/formoterol / Generic mfg. - LARVOL DELTA

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

Improvement of asthma control in adult patients using extrafine inhaled beclomethasone/formoterol fixed combination as maintenance therapy as well as maintenance and reliever therapy - control study. (PubMed, Pulm Pharmacol Ther) - "The use of extrafine BDP/F pMDI HFA as maintenance as well as reliever therapy seems to be associated with increased asthma control and better compliance to therapy."

Journal • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

PATIENT GROUP EDUCATION SESSIONS: AN EFFECTIVE WAY OF MAKING ASTHMA TREATMENT GREENER? (BTS WM 2023) - "All sessions followed the same format: signing confidentiality forms, brief inhaler-focussed asthma education and inhaler technique demonstrations with Fostair®, beclomethasone or salbutamol DPIs. Regarding symptom control, 3-month post-switch ACT scores remain similar to baseline. Nonetheless, device switch rates suggest group sessions offer a potential strategy for improving sustainability of inhaled asthma treatments."

Clinical • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Comparison of extrafine beclomethasone dipropionate/formoterol fumarate dry powder inhaler and pressurized metered-dose inhaler in Chinese patients with asthma: The FORTUNE study. (PubMed, J Asthma) - "The primary objective was met, with no statistically significant difference between the treatments in average pre-dose morning PEF, and with the lower limit of the 95% CI above the -15 L/min non-inferiority margin (adjusted mean difference: 5.25 L/min [95% CI: -0.56, 11.06]). Adverse events were reported by 48.4% and 49.6% patients in the DPI and pMDI groups, respectively, most mild or moderate.ConclusionsThe NEXThaler DPI is a similarly effective device to the pMDI for the administration of BDP/FF in adults, so extending the options available for the management of asthma."

Journal • 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=1400 | Recruiting | Sponsor: Chiesi Farmaceutici S.p.A. | Trial completion date: Jul 2023 ➔ Jul 2024 | Trial primary completion date: Jul 2023 ➔ Jul 2024

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

The effect of lung emptying on the airway deposition of aerosol drugs (ERS 2023) - "Table 1. Relative change of the lung dose as a result of forceful breathe-out in comparison to no breathe-out Drug name Average relative change of lung dose (%) Significance of lung dose change at p=0.05 Onbrez Breezhaler -6.7 significant decrease Relvar Ellipta -1.4 insignificant decrease Seebri Breezhaler -1.1 insignificant decrease Bretaris Genuair 0.3 insignificant increase Foster NEXThaler 3.0 significant increase Bufomix Easyhaler 5.5 significant increase Symbicort Turbuhaler 9.6 significant increase; Respiratory intensive care; Epidemiology; Pulmonary function testing; Cell and molecular biology; General respiratory patient care; Public health"

Critical care

"Usa a Fostair 200/6 2x ao acordar e 2x ao dormir. É um pouquinho cara mas vai mudar sua vida ❤️" (@isabelamagga)

Lupin Launches Luforbec 100/6 for Adult Asthma and COPD Treatment in Germany (Lupin Pharmaceuticals Press Release) - "Hormosan Pharma GmbH...announced the launch of Luforbec®100/6 (beclometasone 100µg / for moterol 6µg), a fix combination in a pressurized metered dose inhaler (pMDI) for the treatment of adult asthma and chronic obstructive pulmonary disease (COPD) in Germany....'The launch of Luforbec® 100/6 pMDI in Germany represents a significant milestone in our goal to establish Hormosan as a key player in the inhalation segment.'"

Launch Europe • Asthma • Chronic Obstructive Pulmonary Disease • Respiratory Diseases