Request Demo

Last update 20 Aug 2026

Beclometasone Dipropionate/Formoterol fumarate Dihydrate/Glycopyrronium Bromide

Last update 20 Aug 2026

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Beclometasone Dipropionate Anhydrous/Formoterol Fumarate Dihydrate/Glycopyrronium, Beclometasone dipropionate anhydrous/formoterol fumarate dihydrate/glycopyrronium bromide, Beclometasone dipropionate/formoterol fumarate dihydrate/glycopyrronium

+ [10]

Target

GR x mAChRs x β2-adrenergic receptor

Action

agonists, antagonists

Mechanism

GR agonists(Glucocorticoid receptor agonists), mAChRs antagonists(Muscarinic acetylcholine receptor antagonists), β2-adrenergic receptor agonists(Beta-2 adrenergic receptor agonists)

Therapeutic Areas

Immune System DiseasesRespiratory Diseases

Active Indication

AsthmaPulmonary Disease, Chronic Obstructive

Inactive Indication

COVID-19Pulmonary Emphysema

Originator Organization

CHIESI Farmaceutici SpA

Active Organization

CHIESI Farmaceutici SpA

Kolon Pharmaceuticals Co., Ltd.

Casey Medical Consulting (Shanghai) Co., Ltd.

+ [1]

Inactive Organization-

License Organization-

Drug Highest PhaseApproved

First Approval Date

European Union (17 Jul 2017),

AsthmaPulmonary Disease, Chronic Obstructive

Regulation-

Structure/Sequence

Molecular FormulaC28H37ClO7

InChIKeyKUVIULQEHSCUHY-XYWKZLDCSA-N

CAS Registry5534-09-8

View All Structures (3)

Clinical Trials associated with Beclometasone Dipropionate/Formoterol fumarate Dihydrate/Glycopyrronium Bromide

CTRI/2026/07/114002

/ Not yet recruitingPhase 3

A Prospective, Randomised, Assessor-blind, Multi-centre, Parallel-group, Active-controlled Study to Evaluate Safety of Beclometasone Dipropionate, Formoterol Fumarate Dihydrate, Glycopyrronium 172-5-9 mcg Pressurised Inhalation Solution -HFO-1234ze[E] versus Trimbow 172-5-9 mcg Pressurised Inhalation Solution HFA-134a in Participants with Asthma. - NIL

Start Date30 Jul 2026

Sponsor / Collaborator

Lupin Research, Inc.

[+1]

CTR20261294

/ RecruitingPhase 3

一项为期24 周、随机、双盲、多中心、阳性对照、双臂、平行分组临床研究：在接受中等剂量吸入糖皮质激素联合长效β2激动剂治疗后病情未控制的哮喘患者中比较 CHF 5993 100/6/12.5 μg HFA-152a pMDI（超细颗粒丙酸倍氯米松/富马酸福莫特罗/格隆溴铵的固定剂量复方制剂）与 CHF 1535 100/6 μg HFA-134a pMDI（超细颗粒丙酸倍氯米松与富马酸福莫特罗的固定剂量复方制剂）的有效性和安全性

[Translation] A 24-week, randomized, double-blind, multicenter, positive-controlled, two-arm, parallel-group clinical study comparing the efficacy and safety of CHF 5993 100/6/12.5 μg HFA-152a pMDI (a fixed-dose combination of ultrafine-particle beclomethasone dipropionate/formoterol fumarate/glycopyrronium bromide) versus CHF 1535 100/6 μg HFA-134a pMDI (a fixed-dose combination of ultrafine-particle beclomethasone dipropionate and formoterol fumarate) in patients with uncontrolled asthma following intermediate-dose inhaled corticosteroids combined with long-acting β2 agonists.

证明与 CHF 1535 100/6 μg pMDI HFA-134a 相比，CHF 5993 pMDI HFA-152a 在第 24 周（访视5，V5）时第1秒用力呼气容积峰值（FEV1，给药后 3小时内）较基线（访视2（V2）给药前）的变化具有优效性。

[Translation]

The results demonstrated that CHF 5993 pMDI HFA-152a was superior to CHF 1535 100/6 μg pMDI HFA-134a in terms of the change in peak forced expiratory volume in one second (FEV1, within 3 hours after administration) at week 24 (visit 5, V5) compared to baseline (before administration at visit 2 (V2)).

Start Date05 Jun 2026

Sponsor / Collaborator

Casey Medical Consulting (Shanghai) Co., Ltd.

NCT07406048

/ RecruitingNot Applicable

A Real-World Study Evaluates the Clinical Characteristics and Effectiveness of COPD Patients Treated With the Triple Combination Beclometasone Diproprionate/Formoterol Fumarate/Glycopyrronium Bromide (BDP/FF/GB) in a Single Pressurised Metered Dose Inhaler (Trimbow® pMDI) in Brazil

This multicenter, retrospective-prospective, cohort study aims to evaluate the effectiveness and safety of Extra-fine Beclometasone Diproprionate/Formoterol Fumarate/Glycopyrronium Bromide (EF-BDP/FF/GB) therapy in adults with severe or very severe COPD in Brazil. Around 400 patients will be enrolled across approximately 15 sites. Eligible patients must have started treatment on the day of enrollment or up to three months before enrollment. Data will be collected both retrospectively and prospectively, with baseline information covering up to 12 months before treatment initiation. All assessments will occur during routine medical visits, with follow-up expected at approximately 3 ± 1 month and 6 months ± 2 months. The medication Trimbow® will not be provided as part of the study and must be prescribed and used according to the institution's standard clinical practice, regardless of participation in the study.

Start Date01 Apr 2026

Sponsor / Collaborator

Chiesi Farmacêutica Ltda.

100 Clinical Results associated with Beclometasone Dipropionate/Formoterol fumarate Dihydrate/Glycopyrronium Bromide

100 Translational Medicine associated with Beclometasone Dipropionate/Formoterol fumarate Dihydrate/Glycopyrronium Bromide

100 Patents (Medical) associated with Beclometasone Dipropionate/Formoterol fumarate Dihydrate/Glycopyrronium Bromide

Literatures (Medical) associated with Beclometasone Dipropionate/Formoterol fumarate Dihydrate/Glycopyrronium Bromide

01 Apr 2026·Lancet Respiratory Medicine

Budesonide–glycopyrronium–formoterol fumarate dihydrate in uncontrolled asthma (KALOS and LOGOS): twin multicentre, double-blind, double-dummy, parallel-group, randomised, phase 3 trials

Article

Author: Bondoc, Marco ; Springer, Katarzyna ; Jackson, David J ; Shah, Mihir ; Papi, Alberto ; Obasi, Chidi ; Helman, Jesse ; Wise, Robert A ; Bowen, Karin ; Patel, Mehul ; Salter, Patricia ; Movitz, Charlotta ; Chen, Ruchong ; Lugogo, Njira ; Pandya, Hitesh ; Megally, Ayman ; Trasieva, Teodora ; Knappenberger, Katharine

BACKGROUND:

Long-acting muscarinic antagonists (LAMA) can be added to inhaled corticosteroid- (ICS)-long-acting β₂-agonist (LABA) therapy for inadequately controlled asthma. We aimed to evaluate the efficacy and safety of budesonide-glycopyrronium-formoterol fumarate dihydrate (BGF) versus budesonide-formoterol fumarate dihydrate using Aerosphere co-suspension delivery technology (BFF_A) and the current suspension formulation (Symbicort, BFF_S).

METHODS:

Two multicentre, randomised, double-blind, double-dummy, phase 3 studies (KALOS and LOGOS) recruited participants aged 12-80 years with inadequately-controlled asthma despite daily medium-dose or high-dose ICS-LABA use from across 378 sites in 20 countries (KALOS), and 324 sites in 15 countries (LOGOS). Participants were randomly assigned (1:1:1:1) to BGF 320 μg, 28·8 μg, 10 μg (BGF 28·8); BGF 320 μg, 14·4 μg, 10 μg (BGF 14·4); BFF_A 320 μg, 10 μg; or BFF_S 320 μg, 9 μg, twice a day via pressurised metered-dose inhaler for 24-52 weeks. Primary lung function endpoints were change from baseline in FEV₁ area under the curve from 0 h to 3 h (AUC_0-3) and in morning pre-dose trough FEV₁ from day 1 to week 24 (over 24 weeks; depending on regional health authority guidance). The primary pooled analysis across both studies was annualised severe exacerbations. The efficacy analysis set and safety set included all randomly assigned participants receiving any amount of study treatment but were analysed according to randomly assigned treatment and received treatment, respectively. The KALOS and LOGOS studies are registered with ClinicalTrials.gov (NCT04609878 and NCT04609904, respectively) and are complete.

FINDINGS:

Between Dec 15, 2020, and March 21, 2025 (KALOS), and between March 1, 2021, and March 20, 2025 (LOGOS), 8820 participants were recruited and 4311 received treatment (1179 received BGF 28·8, 726 received BGF 14·4, 1210 received BFF_A, and 1196 received BFF_S). In each study, the pre-specified multiplicity-adjusted primary endpoints for all regulatory comparisons were met. Least squares mean differences favoured BGF 28·8 for change from baseline in trough FEV₁ and FEV₁ AUC_0-3 across all comparisons (all p<0·05). Least squares mean differences in change from baseline in morning pre-dose trough FEV₁ and in FEV₁ AUC_0-3 over 24 weeks for BGF 28·8 versus BFF_combined were 76 mL (95% CI 57-94; p<0·0001) and 90 mL (72-108; p<0·0001), respectively. BGF 28·8 reduced severe exacerbation rates versus BFF_combined (incidence rate ratio 0·86, 95% CI 0·76-0·97; p=0·012) and versus BFF_S (0·82, 0·71-0·94; p=0·0043). Exacerbation rate ratio for BGF 28·8 versus BFF_A was 0·90 (95% CI 0·78-1·03; p=0·12). 627 (53·2%) adverse events were observed with BGF 28·8, 436 (60·0%) with BGF 14·4, 666 (55·2%) with BFF_A, and 698 (58·4%) with BFF_S. No deaths were treatment related.

INTERPRETATION:

These findings show that BGF improves lung function and reduces severe exacerbation rates in a broad population with asthma inadequately controlled despite medium-dose or high-dose ICS-LABA use. Given that these findings were observed regardless of recent exacerbation history, BGF could benefit individuals with inadequately controlled asthma without requiring a recent episode of acute deterioration on ICS-LABA before escalation.

FUNDING:

AstraZeneca.

01 Mar 2026·Pulmonary Therapy

Real-World Outcomes in Patients with COPD Initiating Budesonide/Glycopyrronium/Formoterol Fumarate Dihydrate After Dual and Triple Therapy in Spain: A Sub-Study of the ORESTES Study

Article

Author: Fitas, Eunice ; Sánchez-Covisa, Joaquín ; Pallarés-Sanmartín, Abel ; Alcázar-Navarrete, Bernardino ; Pascual-Guardia, Sergi ; Gotera-Rivera, Carolina María ; González, Jessica ; Margallo-Iribarnegaray, Juan ; Casitas-Mateo, Raquel ; Corregidor-García, Carmen ; Martín-Lana, Marta ; Saura-Vinuesa, Alberto ; Herrejón-Silvestre, Alberto ; Figueira-Gonçalves, Juan Marco

INTRODUCTION:

Chronic obstructive pulmonary disease (COPD) is a progressive lung condition associated with high morbidity and mortality. Single-inhaler triple therapy (SITT), such as budesonide/glycopyrronium/formoterol fumarate dihydrate (BGF), is recommended for patients with COPD who are not adequately controlled by dual therapy (DT). Escalation from DT or switching from triple therapy (TT)-SITT or multiple-inhaler TT (MITT)-are key real-world treatment pathways.

METHODS:

The observational, retrospective, multicenter ORESTES study included adults (≥ 40 years) with COPD initiating BGF in routine clinical practice. This secondary analysis focuses on the following treatment pathways: escalation from DT and switch from TT. Patients' characteristics, exacerbations, additional COPD treatments, and healthcare resource utilization (HCRU) were assessed.

RESULTS:

A total of 295 patients escalated from DT and 356 switched from TT (SITT: 147; MITT: 209) to BGF. 66.8% of patients escalating from DT and 78.5% switching from TT showed a high-risk GesEPOC phenotype; 77.9% and 80.0% had mMRC grade ≥ 2, and 91.2% and 96.1% had ≥ 3 comorbidities. Following BGF initiation, the annualized exacerbation rate decreased by 11.6% (from 1.06 to 0.94) in patients escalating from DT and by 15.5% (from 1.60 to 1.35) in patients switching from TT (after SITT: 17.8% reduction; after MITT: 14.1%). Rescue medication use declined overall, and specifically short-acting beta-2 agonists (SABA) use declined by 23.2% and 19.4% (SITT: 21.9%; MITT: 18.4%). Emergency room visits and hospitalizations decreased by 19.7% and 19.0% in patients escalating from DT, and by 29.4% and 25.5% among those switching from TT (SITT: 25.0%/18.3%; MITT: 32.4%/29.9%).

CONCLUSIONS:

In this real-world Spanish cohort of patients with COPD not adequately controlled with DT or TT, reductions in exacerbations, rescue medication use, and HCRU were observed after BGF initiation, supporting the potential value of earlier introduction of BGF in patients with persistent symptoms and/or frequent exacerbations despite high-intensity therapy.

CLINICAL TRIAL REGISTRATION:

NCT06321731.

01 Mar 2026·CLINICAL THERAPEUTICS

Safety Assessment of Budesonide/Formoterol: Real-World Pharmacovigilance Analysis Using the FAERS, JADER, and CVAR Databases

Article

Author: Zou, Fan ; Chen, Zhenyong ; Zhu, Chengyu ; Lan, Yuanbo ; Cui, Zhiwei

BACKGROUND:

Asthma and chronic obstructive pulmonary disease are common respiratory disorders with significant global health implications. Budesonide/formoterol (Symbicort) is a fixed-dose inhaler combining budesonide and formoterol fumarate dihydrate, widely used for disease management. While its clinical efficacy is well established, there is an increasing number of adverse drug event (ADE) reports, highlighting the need for thorough real-world safety evaluations.

METHODS:

We performed a retrospective pharmacovigilance study using three major spontaneous reporting systems: the US Food and Drug Administration Adverse Event Reporting System (FAERS), the Japanese Adverse Drug Event Report (JADER), and the Canada Vigilance Adverse Reaction Database (CVARD). We used multiple disproportionality algorithms, including reporting odds ratio, proportional reporting ratio, Bayesian confidence propagation neural network, and multi-item gamma Poisson shrinker for signal detection. Additionally, subgroup and sensitivity, along with logistic regression, were performed. Weibull distribution and log-rank testing were used to assess event timing.

RESULTS:

A total of 30,689 ADEs were identified in FAERS, spanning 27 system organ classes. Expected signals such as cough, dysphonia, and bronchitis were confirmed. Unexpected events included dyspnea, visual and memory impairment, coronary artery embolism, and asthmatic crisis. Sex-stratified analysis revealed female-specific risks (eg, malaise, bronchitis, alopecia, weight gain) and male-specific risks (eg, dysuria, myocardial infarction). Younger patients (<18 years) were at higher risk for asthmatic crisis, whereas older patients (>65 years) showed a protective effect. The median onset of ADEs was 55 days. Distinctive signals emerged from JADER (eg, pneumonia, liver injury) and CVARD (eg, hemoptysis, hypothyroidism).

CONCLUSIONS:

This multi-database analysis highlights the need for continuous pharmacovigilance for budesonide/formoterol. The identification of novel ADE signals emphasizes the importance of vigilant monitoring, especially during early treatment, to enhance safety and therapeutic outcomes.

News (Medical) associated with Beclometasone Dipropionate/Formoterol fumarate Dihydrate/Glycopyrronium Bromide

13 Feb 2026

·www.biospace.com

Positive and clinically meaningful results from the Phase III KALOS and LOGOS trials for BREZTRI in patients with uncontrolled asthma published in The Lancet Respiratory Medicine

WILMINGTON, Del.--(BUSINESS WIRE)--Full results from the positive Phase III KALOS and LOGOS trials published in The Lancet Respiratory Medicine showed AstraZeneca’s BREZTRI Aerosphere (budesonide/glycopyrronium/formoterol fumarate or BGF (320/28.8/9.6μg)) demonstrated statistically significant and clinically meaningful improvements in patients with uncontrolled asthma compared with dual-combination inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) medicines: S ymbicort (budesonide/formoterol fumarate or BFF, a standard therapeutic option), PT009 (BFF in an Aerosphere formulation) and the Symbicort and PT009 treatment groups combined. 1 BREZTRI is a single-inhaler, fixed-dose triple-combination of ICS/LABA and a long-acting muscarinic antagonist (LAMA). In a pre-specified pooled analysis of the primary endpoints across the KALOS and LOGOS trials, BREZTRI improved lung function by 76mL (95% CI 57-94 mL, unadjusted p<0.001, as measured by morning pre-dose trough FEV 1 over 24 weeks) and 90mL (95% CI 72-108 mL, unadjusted p<0.001, as measured by FEV 1 AUC 0-3 over 24 weeks) versus dual therapy (the ICS/LABA treatment groups combined). 1 In the pooled analysis of KALOS and LOGOS, BREZTRI also demonstrated clinically meaningful reductions in the annualized rate of severe asthma exacerbations versus ICS/LABA medicines in patients with or without a recent asthma exacerbation. Full results can be found in The Lancet Respiratory Medicine . Alberto Papi, Professor and Chair of Respiratory Medicine at the University of Ferrara, and Director of the Respiratory Unit, CardioRespiratory Department, S. Anna University Hospital, Ferrara, Italy, and primary investigator, said: “Many of the 262 million people worldwide living with asthma remain uncontrolled and still struggle with symptoms like frequent breathlessness, coughing and wheezing despite the use of dual maintenance therapy. The KALOS and LOGOS trials show that the single fixed-dose triple therapy budesonide/glycopyrronium/formoterol, which combines the efficacy of an ICS, LAMA, and LABA, improved lung function, and, importantly, prevented future severe exacerbations in patients, regardless of exacerbation history.” Sharon Barr, Executive Vice President, BioPharmaceuticals R&D, AstraZeneca, said: “With so many patients still experiencing the debilitating effects of uncontrolled asthma, we are excited about the potential for BREZTRI to improve lung function as well as prevent exacerbations in asthma. Building on its well-established pro COPD, we hope to bring BREZTRI to patients with uncontrolled asthma as quickly as possible.” There were no new safety or tolerability signals identified for BREZTRI in KALOS or LOGOS. BREZTRI is an inhaled triple-combination therapy approved for the treatment of chronic obstructive pulmonary disease (COPD) in adults in more than 80 countries worldwide including the US, EU, China and Japan. Regulatory filings for BREZTRI in asthma are currently under review in all major regions. BREZTRI AEROSPHERE ® (budesonide, glycopyrrolate, and formoterol fumarate) Inhalation Aerosol BREZTRI is contraindicated in patients who have a hypersensitivity to budesonide, glycopyrrolate, formoterol fumarate, or product excipients BREZTRI is not indicated for treatment of asthma. Long-acting beta2-adrenergic agonist (LABA) monotherapy for asthma is associated with an increased risk of asthma-related death. These findings are considered a class effect of LABA monotherapy. When a LABA is used in fixed-dose combination with ICS, data from large clinical trials do not show a significant increase in the risk of serious asthma-related events (hospitalizations, intubations, death) compared with ICS alone. Available data do not suggest an increased risk of death with use of LABA in patients with COPD BREZTRI should not be initiated in patients with acutely deteriorating COPD, which may be a life-threatening condition BREZTRI is NOT a rescue inhaler. Do NOT use to relieve acute symptoms; treat with an inhaled short-acting beta2-agonist BREZTRI should not be used more often than recommended; at higher doses than recommended; or in combination with LABA-containing medicines, due to risk of overdose. Clinically significant cardiovascular effects and fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs Oropharyngeal candidiasis has occurred in patients treated with orally inhaled drug products containing budesonide. Advise patients to rinse their mouths with water without swallowing after inhalation Lower respiratory tract infections, including pneumonia, have been reported following ICS. Physicians should remain vigilant for the possible development of pneumonia in patients with COPD as the clinical features of pneumonia and exacerbations frequently overlap Due to possible immunosuppression, potential worsening of infections could occur. Use with caution. A more serious or fatal course of chickenpox or measles can occur in susceptible patients Particular care is needed for patients transferred from systemic corticosteroids to ICS because deaths due to adrenal insufficiency have occurred in patients during and after transfer. Taper patients slowly from systemic corticosteroids if transferring to BREZTRI Hypercorticism and adrenal suppression may occur with regular or very high dosage in susceptible individuals. If such changes occur, consider appropriate therapy Caution should be exercised when considering the coadministration of BREZTRI with long-term ketoconazole and other known strong CYP3A4 Inhibitors. Adverse effects related to increased systemic exposure to budesonide may occur If paradoxical bronchospasm occurs, discontinue BREZTRI immediately and institute alternative therapy Anaphylaxis and other hypersensitivity reactions (eg, angioedema, urticaria or rash) have been reported. Discontinue and consider alternative therapy Use caution in patients with cardiovascular disorders, especially coronary insufficiency, as formoterol fumarate can produce a clinically significant cardiovascular effect in some patients as measured by increases in pulse rate, systolic or diastolic blood pressure, and also cardiac arrhythmias, such as supraventricular tachycardia and extrasystoles Decreases in bone mineral density have been observed with long-term administration of ICS. Assess initially and periodically thereafter in patients at high risk for decreased bone mineral content Glaucoma and cataracts may occur with long-term use of ICS. Worsening of narrow-angle glaucoma may occur, so use with caution. Consider referral to an ophthalmologist in patients who develop ocular symptoms or use BREZTRI long term. Instruct patients to contact a healthcare provider immediately if symptoms occur Worsening of urinary retention may occur. Use with caution in patients with prostatic hyperplasia or bladder-neck obstruction. Instruct patients to contact a healthcare provider immediately if symptoms occur Use caution in patients with convulsive disorders, thyrotoxicosis, diabetes mellitus, and ketoacidosis or unusually responsive to sympathomimetic amines Be alert to hypokalemia or hyperglycemia Most common adverse reactions in a 52-week trial (incidence ≥ 2%) were upper respiratory tract infection (5.7%), pneumonia (4.6%), back pain (3.1%), oral candidiasis (3.0%), influenza (2.9%), muscle spasms (2.8%), urinary tract infection (2.7%), cough (2.7%), sinusitis (2.6%), and diarrhea (2.1%). In a 24-week trial, adverse reactions (incidence ≥ 2%) were dysphonia (3.3%) and muscle spasms (3.3%) BREZTRI should be administered with extreme caution to patients being treated with monoamine oxidase inhibitors and tricyclic antidepressants, as these may potentiate the effect of formoterol fumarate on the cardiovascular system BREZTRI should be administered with caution to patients being treated with: Strong cytochrome P450 3A4 inhibitors (may cause systemic corticosteroid effects) Adrenergic drugs (may potentiate effects of formoterol fumarate) Xanthine derivatives, steroids, or non-potassium sparing diuretics (may potentiate hypokalemia and/or ECG changes) Beta-blockers (may block bronchodilatory effects of beta-agonists and produce severe bronchospasm) Anticholinergic-containing drugs (may interact additively). Avoid use with BREZTRI Use BREZTRI with caution in patients with hepatic impairment, as budesonide and formoterol fumarate systemic exposure may increase. Patients with severe hepatic disease should be closely monitored INDICATION BREZTRI AEROSPHERE is indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). LIMITATIONS OF USE Not indicated for the relief of acute bronchospasm or for the treatment of asthma. Please see full BREZTRI Prescribing Information , including Patient Information . You may report side effects related to AstraZeneca products . Notes Asthma Asthma is a prevalent, chronic respiratory disease affecting as many as 262 million people worldwide, 2 including over 25 million in the US. 3 When uncontrolled, inflammation and muscle tightening in the airway (bronchoconstriction) may cause wheezing, breathlessness, chest tightness, coughing, and even death. 2,4 Many patients remain uncontrolled despite the availability of standard of care medicines and continue to experience significant limitations on lung function and reduced quality of life. 5,6 KALOS and LOGOS Phase III trials KALOS and LOGOS were replicate confirmatory, randomised, double-blind, double-dummy, parallel group, multi-centre, 24-to-52-week variable length Phase III trials to assess the efficacy and safety of BREZTRI Aerosphere (320/28.8/9.6μg and 320/14.4/9.6μg) compared with two fixed-dose, dual-combination therapies of budesonide, an ICS, and formoterol fumarate, a LABA: Symbicort pressurised metered-dose inhaler (pMDI) and PT009 (in an Aerosphere formulation). 1,7,8 KALOS and LOGOS included approximately 4,300 randomised patients. The trial design was optimised to evaluate the 320/28.8/9.6μg dose of BGF. The primary efficacy endpoints for the two individual trials were the change from baseline in forced expiratory volume in 1 second (FEV 1 ) area under the curve 0 to 3 hours (AUC 0-3 ) at Week 24 and trough FEV 1 over 12-24 weeks and over 24 weeks. 1,7,8 The primary endpoints and treatment comparisons in the KALOS and LOGOS trials differed according to regulatory submission approaches. The full results published in The Lancet Respiratory Medicine report the pooled analysis of KALOS and LOGOS results for BREZTRI compared with the ICS/LABA treatment groups combined, and includes comparisons of BREZTRI to individual comparators arms measured across both trials in the supplement. In addition to the two registrational trials (KALOS and LOGOS), two qualifying trials, LITHOS and VATHOS, also met their primary endpoints. 9,10 LITHOS and VATHOS included approximately 1,000 randomised patients. BREZTRI/TRIXEO Aerosphere Budesonide/glycopyrronium/formoterol fumarate (BGF), approved under the brand name BREZTRI Aerosphere in Japan, China and the US, and TRIXERO Aerosphere in the EU, is a single-inhaler, fixed-dose triple-combination of formoterol fumarate, a LABA, glycopyrronium bromide, a long-acting muscarinic antagonist (LAMA), with budesonide, an ICS, and delivered via the Aerosphere pMDI. BREZTRI/TRIXEO Aerosphere (320/14.4/9.6μg) is approved to treat adults with COPD in more than 80 countries worldwide including the US, EU, China, Japan, and was prescribed to more than 5.5 million patients globally in 2024. 11 AstraZeneca in Respiratory & Immunology Respiratory & Immunology, part of AstraZeneca BioPharmaceuticals, is a key disease area and growth driver to the Company. AstraZeneca is an established leader in respiratory care with a 50-year heritage and a growing portfolio of medicines in immune-mediated diseases. The Company is committed to addressing the vast unmet needs of these chronic, often debilitating, diseases with a pipeline and portfolio of inhaled medicines, biologics and new modalities aimed at previously unreachable biologic targets. Our ambition is to deliver life-changing medicines that help eliminate COPD as a leading cause of death, eliminate asthma attacks and achieve clinical remission in immune-mediated diseases. AstraZeneca AstraZeneca (LSE/STO/NYSE: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialization of prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca’s innovative medicines are sold in more than 125 countries and used by millions of patients worldwide. Please visit astrazeneca-us.com and follow the Company on social media @AstraZeneca . The contents of AstraZeneca’s website do not form part of this document and no one should rely on such websites or the contents thereof in reading this document. References Papi A, et al. Budesonide–glycopyrronium–formoterol fumarate dihydrate in uncontrolled asthma (KALOS and LOGOS): twin multicentre, double-blind, double-dummy, parallel-group, randomised, phase 3 trials. Lancet Respir. Med . 2026; (25)00457-6/abstract [Last accessed: February 2026] Global Asthma Network. The Global Asthma Report 2022. [Online]. Available at: . [Last accessed: February 2026]. U.S. Centers for Disease Control and Prevention (CDC). Most Recent National Asthma Data. [Online]. Available at: . [Last accessed: February 2026]. Fernandes AG, et al. Risk factors for death in patients with severe asthma. J Bras Pneumol . 2014; 40 (4): 364-372. Davis J, et al. Burden of asthma among patients adherent to ICS/LABA: A real-world study. J Asthma . 2019 Mar;56(3):332-340. Buhl R, et al. One-year follow up of asthmatic patients newly initiated on treatment with medium- or high-dose inhaled corticosteroid-long-acting β2-agonist in UK primary care settings. Respir Med . 2020 Feb: 162:105859. Clinicaltrials.gov. Study to Assess PT010 in Adult and Adolescent Participants with Inadequately Controlled Asthma (KALOS) [Online]. Available at: . [Last accessed: February 2026]. Clinicaltrials.gov. Study to Assess PT010 in Adult and Adolescent Participants with Inadequately Controlled Asthma (LOGOS) [Online]. Available at: [Last accessed: February 2026]. Clinicaltrials.gov. A 12-week Study to Assess the Efficacy and Safety of Budesonide and Formoterol Fumarate Metered Dose Inhaler Relative to Budesonide Metered Dose Inhaler in Participants with Inadequately Controlled Asthma (LITHOS) [Online]. Available at: . [Last accessed: February 2026]. Clinicaltrials.gov. A 24-Week Efficacy and Safety Study to Assess Budesonide and Formoterol Fumarate Metered Dose Inhaler in Adult and Adolescent Participants with Inadequately Controlled Asthma (VATHOS) [Online]. Available at: . [Last accessed: February 2026]. AstraZeneca Data on File. 2025. REF-270910. Contacts Media Inquiries Fiona Cookson +1 212 814 3923 US Media Mailbox: usmediateam@astrazeneca.com

Clinical ResultPhase 3Drug Approval

15 Oct 2025

·www.globenewswire.com

Chiesi Announces FDA Acceptance of New Drug Application for its Triple Combination Inhaler for the Maintenance Treatment of Asthma

Asthma remains a significant health burden in the U.S., with more than 60% of adults continuing to experience frequent symptoms despite the availability of many treatments.1Chiesi’s single inhaler triple therapy (beclomethasone dipropionate/formoterol fumarate/glycopyrrolate) is designed for the maintenance treatment of asthma in adults, aiming to lower the burden of uncontrolled asthma in the U.S.Chiesi’s single inhaler triple therapy was the first approved in its class outside of the U.S. – and currently commercialized in nearly 50 countries – and its NDA submission signals the company’s expansion of its more than 45 years of leading respiratory expertise to the U.S. market. CARY, N.C., Oct. 15, 2025 (GLOBE NEWSWIRE) -- Chiesi USA, Inc. (key-A-zee), a biopharmaceutical company that supports patients in living their best possible lives through life-changing or lifesaving innovations, today announced that the U.S. Food and Drug Administration has accepted the company’s New Drug Application (NDA) for its investigational maintenance treatment of asthma in adults. Chiesi’s inhaler delivers three active ingredients in a single device, referred to as a single inhaler triple therapy (SITT). Already approved in nearly 50 countries, this product is marketed outside of the U.S. under the brand name TRIMBOW®. “The FDA’s acceptance of Chiesi’s New Drug Application for our fixed-dose triple combination inhaler represents another important step in our journey to delivering solutions that address respiratory needs and reduce the burden that persists for people living with asthma, their caregivers, and the healthcare system in the U.S.,” said Martin Marciniak, Vice President of U.S. Medical Affairs at Chiesi. “Respiratory care is in our DNA--we have created medicines in this area for more than four decades, and transformed respiratory care by creating and commercializing the first triple therapy for asthma outside the U.S. We are bringing our respiratory expertise to the U.S. to help even more people live healthier lives.” Chiesi’s inhaler delivers three active ingredients, beclomethasone dipropionate (BDP), an inhaled corticosteroid; formoterol fumarate (FF), a long-acting beta-agonist (LABA); and glycopyrrolate (G), an anticholinergic in a single device, referred to as a fixed dose triple combination inhaler. It is administered as twice daily in a pressurized metered-dose inhaler (pMDI). The NDA is supported in part by data from the TRIMARAN and TRIGGER studies, which are double-blind, parallel group, randomized, active-controlled Phase 3 trials. These studies evaluated the safety and efficacy of the triple inhaler ingredients (BDP/FF/G) in more than 2,500 patients with uncontrolled asthma.2 “Among the 28 million people in the U.S. who have asthma, many experience symptoms that disrupt daily life and have lasting effects on their lung health and function--and tragically, nine people die from asthma complications every day3,” said Kenneth Mendez, President and CEO of the Asthma and Allergy Foundation of America. “New treatment options offer the potential for improved asthma management. Expanding choices means more opportunities for patients and their care teams to find solutions that meet individual needs and improve quality of life.” Chiesi’s single inhaler triple therapy pressurized metered dose inhaler was the first approved in its class outside of the U.S. and is commercialized in nearly 50 countries, including the European Union, the United Kingdom and China. About AsthmaAsthma is a chronic, inflammatory respiratory disease that causes inflammation in the airways. People who have asthma can experience symptoms such as shortness of breath, wheezing, coughing and chest tightness – often every day for those with severe cases.4 More than 25 million people in the U.S. live with asthma, and for many adults, symptoms remain difficult to manage even with existing treatments.5 In fact, an estimated 60% of adults with asthma continue to experience frequent symptoms, which can lead to trips to the emergency room, interruption to daily activities, missed work, and a lower quality of life.1 Severe asthma attacks can be life-threatening. Centers for Disease Control and Prevention (CDC) data show that more than 3,600 adults die from asthma each year in the U.S., which is an average of nine deaths per day.6 Asthma also places a major burden on the healthcare system and economy, costing the U.S. an estimated $82 billion annually.7 About beclomethasone dipropionate/formoterol fumarate/glycopyrrolateBeclomethasone dipropionate/formoterol fumarate/glycopyrrolate is an investigational, triple combination inhaler under FDA review in the U.S. for maintenance treatment of asthma in adults. It contains three active ingredients: beclomethasone dipropionate (BDP), an inhaled corticosteroid; formoterol fumarate (FF), a long-acting beta-agonist (LABA); and glycopyrrolate (G), an anticholinergic. It is administered as twice-daily, fixed-dose therapy in a pressurized metered-dose inhaler (pMDI) using a particle formulation designed for deep lung deposition. Chiesi’s robust clinical trial program evaluated the safety and efficacy of BDP/FF/G in more than 2,500 patients with uncontrolled asthma. It was the world’s first fixed triple combination in a single inhaler and is commercialized in nearly 50 countries outside of the U.S., including the United Kingdom, the European Union and China. About Chiesi USA Chiesi USA, Inc., headquartered in Cary, North Carolina, is a specialty pharmaceutical company focused on the commercialization of products for the hospital and target office-based specialties. Chiesi USA is a wholly owned subsidiary of privately-owned Chiesi Farmaceutici S.p.A, a global R&D-focused pharmaceutical company based in Parma, Italy. In the United States, the company delivers therapies and enhances care for patients in the areas of acute cardiology, neonatology, cystic fibrosis and rare diseases. Recognized as a Certified B Corporation™, Chiesi is dedicated to improving the health and well-being of its communities through its employee-led corporate social responsibility program, Chiesi in the Community. Innovation, collaboration and impact are the cornerstones of the Chiesi culture. For more information, visit www.chiesiusa.com. Media InquiriesChiesi US Media Relationsus.mediarelations@chiesi.com ____________________________ 1 Centers for Disease Control and Prevention (CDC). (2022, July 1). Uncontrolled Asthma Among Adults, 2019. National Center for Environmental Health. 2 Virchow, Johann Christian et al. Single inhaler extrafine triple therapy in uncontrolled asthma (TRIMARAN and TRIGGER): two doubleblind, parallel-group, randomised, controlled phase 3 trials. The Lancet, Volume 394, Issue 10210, 1737 - 17493 Asthma and Allergy Foundation of America. (2025). Asthma facts and figures. https://aafa.org/wp-content/uploads/2025/04/aafa-asthma-facts-and-figures-1.pdf 4 Centers for Disease Control and Prevention. (2023, September 27). Asthma: About. U.S. Department of Health & Human Services. https://www.cdc.gov/asthma/about/index.html5 Centers for Disease Control and Prevention. (2023, October 5). Asthma surveillance in the United States: 2001–2021 [Data brief]. U.S. Department of Health & Human Services. https://www.cdc.gov/asthma/Asthma-Prevalence-US-2023-508.pdf6 Centers for Disease Control and Prevention. (2024, February 13). Asthma. National Center for Health Statistics. https://www.cdc.gov/nchs/fastats/asthma.htm7 Nurmagambetov, T., Kuwahara, R., & Garbe, P. (2017). State-level medical and absenteeism cost of asthma in the United States. Journal of Asthma, 54(4), 357–370. https://doi.org/10.1080/02770903.2016.1218013 PDF available: http://ml.globenewswire.com/Resource/Download/06cdebc6-ba1c-45f0-a06c-0feffd63ae04

Phase 3Drug ApprovalClinical ResultNDA

05 Dec 2023

·www.fiercepharma.com

Chiesi, buffing up environmental credentials, works with BBC to spread message about greener inhalers

A screenshot from the episode sponsored by Chiesi Chiesi is working with the BBC to show off its climate-conscious credentials, partnering with the British broadcaster on a web series episode about redesigning inhalers to reduce their environmental impact. Pressurized metered dose inhalers such as Chiesi’s Fostair and Trimbow use propellants to get the active ingredient into the respiratory system. Evidence of the effect of the old propellant, chlorofluorocarbons, on the ozone led the industry to switch to hydrofluorocarbons (HFCs). However, it is now clear that HFCs are a powerful greenhouse gas, spurring a push to again change the propellants used in inhalers. Chiesi has highlighted its own work in the area by sponsoring an episode of the series “The Climate and Us” by BBC StoryWorks, the branded content wing of the British broadcaster. The episode looks at the life of Lara, an asthmatic patient with several comorbidities. In the episode, Lara, who lives in the Italian city Livorno, discusses how industrial and exhaust fumes affect her and her son. Inhalers that help Lara cope with poor air quality also contribute to emissions of greenhouse gasses. The episode, which was paid for and presented by Chiesi, goes on to discuss how the development of carbon-minimal inhalers could reduce the impact of asthma drugs on the environment. “Striking the delicate balance between advancing respiratory health treatments and mitigating the environmental footprint of these treatments is a complex challenge. At Chiesi, we strongly believe that patients should not have to shoulder the burden of environmental responsibility when considering treatment options that affect their health,” Chiesi CEO Giuseppe Accogli said in a statement. In the statement to publicize the episode, Chiesi discussed its “significant investments in the development of a new carbon-minimal inhalers platform that will reduce the carbon footprint of its pressurized metered dose inhalers by up to 90%.” The inhalers are still in development. Chiesi is far from the only manufacturer working to make greener inhalers. Last month, GSK disclosed plans to start a phase 3 trial of a low-carbon version of Ventolin, positioning it to cut the use of a propellant that accounts for 49% of its carbon footprint. AstraZeneca and Boehringer Ingelheim have also promoted their work to reduce emissions from their inhalers. The initiatives may help improve the standing of the companies with the large number of patient groups that judge drugmakers based on their green credentials. A recent survey found the impact a pharma company has on the environment is important to 75% of patient groups.

Phase 3

100 Deals associated with Beclometasone Dipropionate/Formoterol fumarate Dihydrate/Glycopyrronium Bromide

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	R03AL09	-

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Asthma	European Union	CHIESI Farmaceutici SpA	17 Jul 2017
Asthma	Iceland	CHIESI Farmaceutici SpA	17 Jul 2017
Asthma	Liechtenstein	CHIESI Farmaceutici SpA	17 Jul 2017
Asthma	Norway	CHIESI Farmaceutici SpA	17 Jul 2017
Pulmonary Disease, Chronic Obstructive	European Union	CHIESI Farmaceutici SpA	17 Jul 2017
Pulmonary Disease, Chronic Obstructive	Iceland	CHIESI Farmaceutici SpA	17 Jul 2017
Pulmonary Disease, Chronic Obstructive	Liechtenstein	CHIESI Farmaceutici SpA	17 Jul 2017
Pulmonary Disease, Chronic Obstructive	Norway	CHIESI Farmaceutici SpA	17 Jul 2017

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Pulmonary Emphysema	Phase 3	Belgium	CHIESI Farmaceutici SpA	18 May 2021
Pulmonary Emphysema	Phase 3	Hungary	CHIESI Farmaceutici SpA	18 May 2021
COVID-19	Phase 2	Brazil	CHIESI Farmaceutici SpA	28 Jun 2021

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01917331 (TRILOGY, CTgov)	Phase 3	Pulmonary Disease, Chronic Obstructive	1,368	Beclometasone/Formoterol/Glycopyrrolate (Beclometasone/Formoterol/Glycopyrrolate)	tlxntiprox(yaglzfhopx) = fyypluqldc zbqseuuvmu (dypkvumekj, funfynfvhi - osohzvjkan) View more	-	03 Jun 2026
				Beclometasone/Formoterol (Beclometasone/Formoterol)	tlxntiprox(yaglzfhopx) = rkrfzpcvfv zbqseuuvmu (dypkvumekj, lruwwyosbw - oxrudbsiog) View more
NCT03197818 (TRIVERSYTI, CTgov)	Phase 3	Pulmonary Disease, Chronic Obstructive	708	CHF 5993+BDP+glycopyrronium bromide+formoterol fumarate (CHF 5993 100/6/12.5 µg - ITT Population)	twjjlzwyxo(ionpojnyig) = uvtsoncjeq inxaetllrb (aakkktzhfp, idzdftfhvd - bassbtkand) View more	-	27 May 2026
				Symbicort Turbuhaler (Symbicort Turbuhaler 160/4.5 µg - ITT Population)	twjjlzwyxo(ionpojnyig) = qwgynmjjrd inxaetllrb (aakkktzhfp, snkbrkyxsy - eurwgmwsex) View more
NCT04876677 (DARWiIN, CTgov)	Phase 3	Pulmonary Disease, Chronic Obstructive \| Pulmonary Emphysema	25	CHF5993 (CHF5993 DPI 100/6/12.5 μg - PP Population)	lmcztnptig(socdosuwyk) = jkgebysawh vjfurrdvzm (sdqpiehoec, 0.6647) View more	-	09 Apr 2026
				SAF+CHF5993 DPI (CHF5993 DPI 100/6/12.5 μg - SAF Population)	zumvylgkij(kmitdbfvaa) = pzklrnrswj toewiprcid (pogfxmfgqk, idezuzhhnz - korpsvewsz) View more
NCT04876677 (Pubmed \| Respir Res)	Phase 3	Pulmonary Disease, Chronic Obstructive	-	Fluticasone propionate/salmeterol (FP/SLM)	zdsdjrjelw(lskrnloxhh) = jmzgwcoxrg bgssohqlwz (ejewafndik )	-	06 Oct 2023
NCT01917331 (TRILOGY, ERS2020)	Phase 3	Severe chronic obstructive pulmonary disease Maintenance	445	extra-fine BDP/FF/GB pMDI	sxzqahkngz(mffwxdyulj): 0.769 (95% CI, 0.632 - 0.936), P-Value = 0.009	Positive	07 Sep 2020
				non-triple maintenance therapies
TRIMARAN (ERS2019)	Phase 3	Asthma Add-on	1,155	extrafine MS beclometasone dipropionate/formoterol fumarate/glycopyrronium bromide (BDP/FF/GB)	kbxacvnhog(dbyopgmtlq) = iigqhxpghj wngircjqqj (bvxotsjrcb )	-	28 Sep 2019
				BDP/FF	kbxacvnhog(dbyopgmtlq) = jstwbltyof wngircjqqj (bvxotsjrcb )
NCT01917331 (TRILOGY, Pubmed \| Lancet) Manual	Phase 3	Pulmonary Disease, Chronic Obstructive	1,368	beclometasone dipropionate, formoterol fumarate, and glycopyrronium bromide	bsqqfniuom(dbkfxeuhvn) = cudnqljeiq kbwxwevuhb (jgrjeajtzi ) View more	Superior	03 Sep 2016
				beclometasone dipropionate and formoterol fumarate	bsqqfniuom(dbkfxeuhvn) = unypqguwbm kbwxwevuhb (jgrjeajtzi ) View more

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

Hiro LS Researcher

The AI Search Engine Built to Accelerate Biopharma Decisions

Search across billion-scale life sciences data to uncover signals, validate evidence, and act with confidence.

Ask any biopharma research question→

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, Patsnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Discover Synapse Data Servers

Synapse data is now integrated into the PatSnap LS Model Context Protocol (MCP) service. Customize your LLM agent now using our MCP server!

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis