Last update 21 Nov 2024

Beclometasone Dipropionate/Formoterol fumarate Dihydrate/Glycopyrronium Bromide

Last update 21 Nov 2024

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

+ [9]

Target

GR x mAChRs x β2-adrenergic receptor

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-

Originator Organization

CHIESI Farmaceutici SpA

Active Organization

CHIESI Farmaceutici SpA

Inactive Organization

Casey Medical Consulting (Shanghai) Co., Ltd.

Drug Highest PhaseApproved

First Approval Date

EU (17 Jul 2017),

AsthmaPulmonary Disease, Chronic Obstructive

Regulation-

Structure

Molecular FormulaC23H28N2O8

InChIKeyZDUPYZMAPCZGJO-DZTPFQSQSA-N

CAS Registry43229-80-7

View All Structures (3)

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

NCT06678191 / RecruitingNot Applicable

Effectiveness of BDP/FF/G 172/5/9 Fixed Triple Combination on Symptom Scores in Asthma Patients After 6 Months Treatment

The mainstay of asthma treatment are ICSs, mostly combined with LABA. In the past decade LAMA had been accepted as an add-on treatment for patients on GINA treatment Steps 4 and 5. Recently, RCTs proved the efficacy and safety of fixed triple combinations of moderate and high dose of ICS and LABA, LAMA in a very selected asthmatic population, resulting in the market authorisation of these products. However, there is a lack of evidence on the real-world effectiveness of these therapies, especially with regards to improvement in symptom scores and quality of life. Also, there is scarcity of data regarding the phenotypes of asthmatics who benefit the most from the use of fixed triple combinations.

Start Date24 Oct 2024

Sponsor / Collaborator-

NCT06567977 / RecruitingNot Applicable

TriMaximize: A Multicentre, Prospective, Non-interventional Trial Monitoring Therapy Pathways of Asthma Patients Treated With an Extra-fine ICS/LABA/LAMA Single-inhaler Triple Therapy in a Real-world Setting and Characterizing the Effects on Health-related Outcomes.

TriMaximize: A multicentre, prospective, non-interventional trial monitoring therapy pathways of asthma patients treated with an extra-fine ICS/LABA/LAMA single-inhaler triple therapy in a real-world setting and characterizing the effects on health-related outcomes.

Start Date01 Aug 2024

Sponsor / Collaborator

GKM Gesellschaft für Therapieforschung mbH

NCT06100042 / RecruitingNot Applicable

Multicentre, Prospective, Non-interventional Study Monitoring Therapy Pathways of Asthma Patients Treated With an Extrafine ICS/LABA/LAMA Single-inhaler Triple Therapy in a Real-world Setting and Characterizing the Effects on Health-related Outcomes

TriMaximize is a non-interventional study aimed to collect prospective data from asthmatic patients under routine care, for whom their treating physician has decided to prescribe BDP/FF/G (beclomethasone/formoterol/glycopyrronium).

Start Date24 Apr 2024

Sponsor / Collaborator

Chiesi Ltd.

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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

03 Oct 2024·Journal of Pharmacy and Pharmacology

Advances in inhaler therapy for asthma and chronic obstructive pulmonary disease: a comprehensive review of Fostair™ and Trimbow™

Review

Author: Foster, Katie ; Wong, Chun Yuen Jerry

AbstractThe management of asthma and chronic obstructive pulmonary disease (COPD) poses considerable challenges due to the intricate nature of these respiratory conditions. Fostair™ and Trimbow™, two pressurized metered dose inhalers, have emerged as noteworthy therapeutic options for treating both asthma and COPD. Fostair combines an inhaled corticosteroid, specifically beclometasone dipropionate, with a long-acting beta2-agonist, formoterol fumarate dihydrate, offering a dual-action approach to mitigate airway inflammation and bronchoconstriction. Conversely, Trimbow integrates a tri-particulate formulation consisting of beclometasone dipropionate, formoterol fumarate dihydrate, and glycopyrronium bromide, providing a comprehensive strategy to target the pathophysiology of COPD and asthma. Recent clinical trials have underscored Trimbow’s superior efficacy compared with Fostair, particularly in terms of reducing exacerbation rates and enhancing lung function. However, despite their therapeutic promise, both inhalers encounter challenges, including limited generalizability of study findings and a disparity between in vitro and human trial results. This literature review offers an in-depth analysis of Fostair and Trimbow, delving into their mechanisms of action, clinical applications, and outcomes in human studies for asthma and COPD. Additionally, the review discusses the role of combination therapy in managing respiratory diseases and underscores the necessity for further research to address existing knowledge gaps and optimize therapeutic outcomes.

01 Jun 2021·Respiratory MedicineQ3 · MEDICINE

TRICOP – A Real-world effectiveness study with a single-inhaler extrafine triple therapy over 52 weeks in Austrian patients with COPD

Q3 · MEDICINE

Article

Author: Marth, Katharina ; Renner, Andreas ; Pohl, Wolfgang

OBJECTIVEEvidence of the efficacy of single-inhaler triple therapy in COPD patients inferred from RCTs has not been assessed in a real-world setting in Austria. In this non-interventional study (NIS) tolerability and effectiveness of extrafine beclometasone-dipropionate, formoterol-fumarate and glycopyrronium (Trimbow® 87/5/9 μg) was evaluated in COPD patients.METHODSA prospective NIS was conducted over 52 weeks in 24 sites in Austria. Eligible COPD patients had an indication for treatment with single-inhaler BDP/FF/G. In this study tolerability, lung function, exacerbation rate, symptom scores and CAT scores were recorded.RESULTS265 patients with moderate to very severe airflow limitation (GOLD Grade 2-4: 96.2%) and persistent symptoms (GOLD B: 62.3%, GOLD D: 34%) according to the 2018 GOLD Report were included. After 52 weeks, a significant improvement was detected in lung function (FEV₁, FEV₁% predicted and FVC; p < 0.001) and symptoms (cough, sputum and shortness of breath; p < 0.001). A clinically relevant improvement in CAT score observed at 12 weeks persisted after 52 weeks in GOLD B and GOLD D patients (p < 0.001), paralleled by a significant reduction of moderate and severe exacerbations by 57.4% and 27.3%, respectively (p < 0.001). After 52 weeks, 93.7% of the patients continued the treatment. Of 21 adverse events reported 16 were non-serious, five were serious, none were deemed drug related.CONCLUSIONSThe present results support the tolerability and effectiveness of extrafine BDP/FF/G in COPD patients in a real-world setting, showing an improvement in lung function, symptom control and a significant reduction in exacerbations.

01 Jan 2021·Journal of Market Access & Health Policy

Impact of health technology assessment on prescribing patterns of inhaled fixed-dose combination triple therapy in chronic obstructive pulmonary disease

Article

Author: Langham, Sue ; Bloom, Chloe ; Cook, Jennifer ; Platz, Jaime Hernando ; Marjenberg, Zoe ; Lewis, Jen

Background: Evidence suggests that triple therapy for patients with chronic obstructive pulmonary disease (COPD) is being used in a broader range of patients than recommended by guidelines, which may have health and cost implications. Objective: To explore the relationship between national health technology assessment (HTA) agency appraisals and market penetration of two fixed-dose combination (FDC) triple therapies. Study design: HTAs from Q3 2017 to Q1 2020 from 10 countries were evaluated. Intervention: Glycopyrronium bromide/formoterol fumarate/beclomethasone (Trimbow®) and umeclidinium/vilanterol/fluticasone furoate (Trelegy™ Ellipta®). Main outcome measure: HTA restrictions and prescribing rates (days of therapy). Results: Seven countries (70%) imposed restrictions on use including prescription only for patients stable on free-combination triple therapy or not controlled on dual therapy, requirement of a specialist prescription or therapeutic plan, prescription only for patients with severe COPD, and use as second-line therapy or later. In general, countries that have imposed restrictions on the use of FDC triple therapies have seen a lower than average uptake. Conclusion: Payer guidance on prescribing FDC triple therapy may potentially support more appropriate prescribing in line with clinical guidelines. It is important for payers to consider which restrictions would ensure the most efficient use of scarce resources.

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

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

01 Feb 2021

·www.biospace.com

Chiesi Group receives the European Marketing authorization for the extrafine triple-combination therapy for the treatment of moderate to severe asthma

PARMA, Italy, Feb. 01, 2021 (GLOBE NEWSWIRE) -- Chiesi, an international research-focused Healthcare group (Chiesi Group), announces that the European Commission has granted the marketing authorization for Chiesi extrafine triple therapy combination ICS/LABA/LAMA in a single inhaler, for the treatment of asthma. This follows the 2017 approval of this therapeutic option for the treatment of Chronic Obstructive Pulmonary Disease (COPD).1 The triple therapy is a combination of Inhaled Corticosteroid (ICS) / Long-acting β2-agonist (LABA)/long-acting muscarinic antagonist (LAMA) that contains Beclometasone dipropionate (BDP; inhaled corticosteroid), Formoterol fumarate (FF; long-acting β2 agonist) and Glycopyrronium (G; long-acting muscarinic antagonist).1,2 Chiesi triple therapy for asthma is the first extrafine triple combination able to reach and treat the whole bronchial tree, including small airways.2,3 Chiesi’s Modulite extrafine particle technology potentially facilitating coordination of inhalation.4,5 The product is provided with a dose counter that allow patients to track and manage their treatment efficiently.2 “This is the first step towards taking our triple therapy for COPD patients and providing the same treatment option for Asthma patients,” said Alessandro Chiesi, Chiesi Group Chief Commercial Officer. “Chiesi is committed to developing and delivering alternatives to aid patients in the management of their respiratory conditions and treatment. The European Commission approval brings us one step closer to providing uncontrolled asthma patients with new treatment options for their care, reducing exacerbations and potentially simplifying the use for patients thanks to a single inhaler triple therapy.” Asthma is a chronic inflammatory disease affecting over 339 million people worldwide.6 According to GINA Report, people with uncontrolled asthma have poor symptom control and/or frequent exacerbations requiring oral corticosteroids or experience serious exacerbations requiring hospitalization.7 In patients with uncontrolled asthma, Chiesi triple therapy has been shown to reduce exacerbations and improve lung function in comparison to ICS/LABA (Inhaled Corticosteroid / Long-acting beta-agonist).4 The CHMP recommendation and the European Commission decision are based on the efficacy and safety data of 4 clinical studies involving close to 3,000 patients. About Chiesi Group Based in Parma, Italy, Chiesi Farmaceutici is an international research-focused healthcare group with 85 years of experience in the pharmaceutical industry and a global presence in 29 countries. Chiesi researches, develops, and markets innovative drugs in the respiratory therapeutics, specialist medicine, and rare disease areas. Its R&D organization is headquartered in Parma (Italy), and is integrated with R&D groups in France, the USA, the UK and Sweden to advance Chiesi's pre-clinical, clinical and registration programs. Chiesi employs over 6,000 people. Chiesi Group is a certified Benefit corporation. For more information, please visit . About Chiesi triple therapy Chiesi triple therapy is the first extrafine fixed triple combination of Inhaled Corticosteroid (ICS) / Long-acting β2-agonist (LABA) / long-acting muscarinic antagonist (LAMA) that contains Beclometasone dipropionate (BDP), Formoterol fumarate (FF) and Glycopyrronium (G). Trimbow will be available as twice a day pMDI (pressurized metered dose inhaler) to be licensed for maintenance treatment of asthma, in adults not adequately controlled with a maintenance combination of a long-acting beta2-agonist and a medium dose of inhaled corticosteroid, and who experienced one or more asthma exacerbations in the previous year. Chiesi triple therapy is also approved in COPD as maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (COPD) who are not adequately treated by a combination of an inhaled corticosteroid and a long-acting beta2-agonist or a combination of a long-acting beta2-agonist and a long-acting muscarinic antagonist.2 About Asthma Asthma is a common long-term condition that can affect people of all ages and causes inflammation in the airways. The prevalence of asthma in the European Union (EU) is 8.2% in adults and 9.4% in children. Difficult-to-treat, or severe asthma occurs in 24% of patients. The direct and indirect costs of asthma to societies are substantial. Recent calculations estimate direct costs within the EU to be nearly €20 billion, indirect costs to be €14 billion and a monetised value of DALYs lost to be €38 billion, which totals €72 billion.8 Valentina Biagini, Senior Global Communication Manager Mobile: +39 348 7693 623 E-mail: v.biagini@chiesi.com References Trimbow, EMEA/H/C/004257, EMA marketing authorisation valid throughout the European Union, approved 17/07/2017, Trimbow SmPC Usmani et al., JOURNAL OF AEROSOL MEDICINE AND PULMONARY DRUG DELIVERY 2020 Pp. 1–8 JC Virchow et al., Lancet 2019; 394: 1737–49 Nicolini at al. - The Clin Risk Manag 2008; 4(5):855-864 WHO, Asthma Facts: GINA, Difficult-to-treat & severe asthma in adolescent and adult patients, Diagnosis Management, A GINA Pocket Guide for Health Professionals, 2019, Selroos O et al. National and regional asthma programmes in Europe. Eur Respir Rev 2015; 24: 474–483 PDF available:

Innovative Drug

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.

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Indication	Country/Location	Organization	Date
Asthma	IS	CHIESI Farmaceutici SpA	17 Jul 2017
Asthma	NO	CHIESI Farmaceutici SpA	17 Jul 2017
Asthma	LI	CHIESI Farmaceutici SpA	17 Jul 2017
Asthma	EU	CHIESI Farmaceutici SpA	17 Jul 2017
Pulmonary Disease, Chronic Obstructive	IS	CHIESI Farmaceutici SpA	17 Jul 2017
Pulmonary Disease, Chronic Obstructive	EU	CHIESI Farmaceutici SpA	17 Jul 2017
Pulmonary Disease, Chronic Obstructive	LI	CHIESI Farmaceutici SpA	17 Jul 2017
Pulmonary Disease, Chronic Obstructive	NO	CHIESI Farmaceutici SpA	17 Jul 2017

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Asthma	Phase 3	AM	CHIESI Farmaceutici SpA	27 Nov 2023
Asthma	Phase 3	RS	CHIESI Farmaceutici SpA	27 Nov 2023
Asthma	Phase 3	GE	CHIESI Farmaceutici SpA	27 Nov 2023
Asthma	Phase 3	GB	CHIESI Farmaceutici SpA	27 Nov 2023
Pulmonary Disease, Chronic Obstructive	Preclinical	CN	Casey Medical Consulting (Shanghai) Co., Ltd.	14 Dec 2016

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01917331 (TRILOGY, ERS2020)	Phase 3	Severe chronic obstructive pulmonary disease Maintenance	445	extra-fine BDP/FF/GB pMDI	axghncnlnp(mcmkiqwfuq): 0.769 (95% CI, 0.632 - 0.936), P-Value = 0.009	Positive	07 Sep 2020
				non-triple maintenance therapies
TRINITY (ERS2016)	Phase 3	Pulmonary Disease, Chronic Obstructive	2,691	CHF5993 (extrafine triple combination of BDP/FF/GB pMDI)	xszebzkbpp(uqkrrwsxms) = mihsbmtqlp cnuyiyglvn (ancnjdaksn, 0.037 - 0.086)	Positive	01 Sep 2016
				Foster® (BDP/FF pMDI) + Tiotropium	xszebzkbpp(uqkrrwsxms) = wwdbjjgnnm cnuyiyglvn (ancnjdaksn, -0.033 to 0.027)

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