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

Therapeutic Areas

Infectious DiseasesRespiratory DiseasesImmune System Diseases

Active Indication

Bronchitis, ChronicPulmonary Disease, Chronic ObstructivePulmonary Emphysema+ [4]

Inactive Indication-

Originator Organization

AstraZeneca PLC

Active Organization

AstraZeneca PLC

AstraZeneca Investment (China) Co. Ltd.

Pearl Therapeutics, Inc.

+ [4]

Inactive Organization-

License Organization-

Drug Highest PhaseApproved

First Approval Date

Japan (18 Jun 2019),

Bronchitis, ChronicPulmonary Disease, Chronic ObstructivePulmonary Emphysema

Regulation-

Structure/Sequence

Molecular FormulaC25H34O6

InChIKeyVOVIALXJUBGFJZ-KWVAZRHASA-N

CAS Registry51333-22-3

View All Structures (3)

Clinical Trials associated with Budesonide/Formoterol fumarate/Glycopyrronium Bromide

NCT07073950

/ Not yet recruitingPhase 4

A Randomised, Double-blind, Multi-centre, Placebo-controlled, Crossover Study to Assess the Effect of Budesonide/Glycopyrronium/Formoterol Fumarate Metered Dose Inhaler on Cardiac and Lung Function in Participants With Chronic Obstructive Pulmonary Disease and Hyperinflation

The purpose of the study is to evaluate the effect of BGF MDI compared with placebo MDI on cardiac and lung function when administered in participants diagnosed with COPD and hyperinflation.

Start Date30 Sep 2025

Sponsor / Collaborator

AstraZeneca PLC

[+1]

NCT06531798

/ Not yet recruitingPhase 4

Post-marketing Phase IV, Multicenter, Prospective Study to Observe the Safety and Tolerability of Breztri aerosphereTM Containing a Fixed Dose Combination of Budesonide 160 mcg/ Glycopyrronium 7.2 mcg/ Formoterol Fumarate Dehydrate 5 mcg in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease

The purpose of this study is to observe the safety and tolerability of Breztri aerosphereTM as maintenance treatment in Indian patients with moderate to severe COPD.

Start Date30 Jul 2025

Sponsor / Collaborator

AstraZeneca PLC

NCT06712563

/ RecruitingNot Applicable

Pooled Analysis of Multi-country, Open-label Single-arm, Non-interventional, Multi-center, Cohort Studies of Real-world Outcomes in New Users of Budesonide/Glycopyrronium/Formoterol (BGF) in Routine Care Setting

The CHOROS pooled analysis is a retrospective secondary data use analysis of integrated individual participant data from a series of planned and on-going primary prospective, non-interventional, multi-center studies sponsored by AstraZeneca and conducted in the pulmonary/primary care practitioner setting in multiple countries and may include data from the following countries: United Kingdom, Germany, Italy, Greece, Japan, Canada and Romania.

Start Date17 Apr 2025

Sponsor / Collaborator

AstraZeneca PLC

100 Clinical Results associated with Budesonide/Formoterol fumarate/Glycopyrronium Bromide

100 Translational Medicine associated with Budesonide/Formoterol fumarate/Glycopyrronium Bromide

100 Patents (Medical) associated with Budesonide/Formoterol fumarate/Glycopyrronium Bromide

Literatures (Medical) associated with Budesonide/Formoterol fumarate/Glycopyrronium Bromide

01 Sep 2025·Respiratory Investigation

Real-world effectiveness of budesonide/glycopyrronium/formoterol fumarate metered dose inhaler on symptoms and quality of life in patients with COPD: EBISU study

Article

Author: Kawayama, Tomotaka ; Nishida, Kenichiro ; Kato, Yuki ; Yoshida, Yuri ; Hirai, Takehiro ; Sugiura, Hisatoshi ; Makita, Naoyuki ; Muro, Shigeo ; Hozawa, Soichiro

BACKGROUND:

There are limited real-world data regarding triple therapy with inhaled corticosteroid/long-acting muscarinic antagonist/long-acting β₂-agonist on symptoms and patient-reported outcomes (PROs) in patients with chronic obstructive pulmonary disease (COPD), without current/history of asthma. We investigated the effects of budesonide/glycopyrronium/formoterol fumarate (BGF) metered dose inhaler (MDI) triple therapy on health status and PROs in patients with COPD in daily clinical practice.

METHODS:

This was a 12-week, prospective, multicenter, observational study (NCT05219630). The primary endpoint was mean change from baseline in the COPD Assessment Test (CAT) over 12 weeks. Secondary and exploratory endpoints included mean change from baseline in the St George's Respiratory Questionnaire (SGRQ) over 12 weeks and CAT score subgroup analyses.

RESULTS:

In total, 102 patients were analyzed; mean age at baseline was 73.8 years, mean forced expiratory volume in 1 s was 57.7 %, CAT total score was 15.6, and SGRQ score was 33.3. The adjusted mean change from baseline over 12 weeks in CAT was -2.9 (standard error [SE] 0.5) (P < 0.001), and in SGRQ was -2.7 (SE 0.9) (P = 0.004). As early as Week 4, these scores were significantly improved from baseline. In subgroup analyses, CAT scores were improved, regardless of blood eosinophil counts at baseline and exacerbation history in the previous year.

CONCLUSIONS:

Triple therapy with a BGF MDI significantly improved CAT and SGRQ scores over 12 weeks. BGF MDI could be a suitable option for patients living with COPD who have persistent symptoms without current asthma or a history of asthma.

TRIAL REGISTRATION:

ClinicalTrials.gov (NCT05219630).

19 Jul 2025·BMC Pulmonary Medicine

Effect of triple therapy on mortality and cardiovascular risk in patients with moderate to severe COPD: a meta-analysis of randomized controlled trials.

Review

Author: Li, Yubing ; Li, Jun ; Zhang, Yong ; Yang, Hongxia

BACKGROUND:

Chronic obstructive pulmonary disease (COPD), the third leading cause of global mortality, remains a significant challenge in long-term management. While dual bronchodilators (LAMA/LABA) and inhaled corticosteroid combination therapies (ICS/LABA) alleviate symptoms, patients continue to face elevated risks of all-cause mortality and cardiovascular events. Recent studies suggest that triple therapy (ICS/LAMA/LABA) may improve outcomes by reducing acute exacerbations and systemic inflammation. However, its long-term effects on mortality and cardiovascular safety remain controversial, highlighting the critical need for systematic evidence to inform clinical decision-making.

METHODS:

A systematic search of PubMed, Embase, and the Cochrane Library (up to July 2024) identified 13 randomized controlled trials (RCTs) comparing triple therapy with dual therapies (LAMA/LABA or ICS/LABA) in patients with moderate-to-severe COPD. Outcomes included all-cause mortality, exacerbation rates, and cardiovascular adverse events of special interest (CVAESI). Risk ratios (RR) with 95% confidence intervals (CI) were calculated using fixed- or random-effects models based on heterogeneity (assessed via I² statistics). Subgroup analyses explored heterogeneity across drug combinations, supplemented by sensitivity analyses and publication bias assessments.

RESULTS:

Compared to LAMA/LABA dual therapy, triple therapy significantly reduced all-cause mortality (RR = 0.76, 95% CI = 0.60-0.97, p = 0.03), moderate-to-severe exacerbation risk (RR = 0.93, 95% CI = 0.90-0.97, p = 0.0003), and overall CVAESI incidence (RR = 0.75, 95% CI = 0.61-0.93, p = 0.008), with a 38% reduction in severe CVAESI (hospitalized or fatal events: RR = 0.62, 95% CI = 0.45-0.86, p = 0.004). Subgroup analyses demonstrated that the BGF regimen achieved superior reductions in CVAESI (RR = 0.72, 95% CI = 0.58-0.89, p = 0.003) and severe CVAESI (RR = 0.61, 95% CI = 0.47-0.79, p = 0.0002) compared to other triple therapies. Although BGF showed only a nonsignificant trend toward mortality reduction (RR = 0.77, 95% CI = 0.58-1.03, p = 0.08), it exhibited greater efficacy in reducing exacerbations (RR = 0.72 vs. non-BGF regimens) and cardiovascular risks. Non-BGF triple therapies yielded inconclusive results due to limited sample sizes and substantial heterogeneity (I²=62-83%, subgroup difference p < 0.05). Sensitivity analyses confirmed the stability of pooled estimates (< 5% variation upon study exclusion), with no significant publication bias detected via funnel plots or Begg's test (p > 0.05).

CONCLUSION:

This study confirms that ICS/LAMA/LABA triple therapy significantly reduces mortality, exacerbations, and cardiovascular risks in moderate-to-severe COPD compared to LAMA/LABA dual therapy. The BGF regimen, with optimized drug delivery and synergistic anti-inflammatory/bronchodilatory effects, shows superior clinical benefits, especially in high-risk patients. However, triple therapy did not improve survival or cardiovascular outcomes versus ICS/LABA. Differences in ICS pharmacokinetics highlight the need for personalized strategies based on eosinophil levels and adherence. BGF may be considered a preferred option for patients at high risk of exacerbations or with cardiovascular comorbidities. Future studies should compare triple therapies head-to-head and standardize cardiovascular endpoints to clarify long-term outcomes.

01 Apr 2025·AMERICAN JOURNAL OF MEDICINE

Effectiveness of Single Versus Multiple Inhaler Triple Therapy on Mortality and Cardiopulmonary Risk Reduction in COPD: The SKOPOS-MAZI Study

Article

Author: Müllerová, Hana ; Vogelmeier, Claus F. ; Hawkins, Nathaniel M ; Rhodes, Kirsty ; Vogelmeier, Claus F ; Marshall, Jonathan ; Pollack, Michael ; Anzueto, Antonio ; Hawkins, Nathaniel M. ; Rapsomaniki, Eleni

BACKGROUND:

Patients with chronic obstructive pulmonary disease (COPD) have elevated cardiopulmonary and mortality risk, particularly following exacerbations. While single inhaler triple therapies (SITTs), such as budesonide/glycopyrrolate/formoterol fumarate (BGF), reduce cardiopulmonary risk versus dual bronchodilator therapy, there is limited evidence comparing outcomes with SITTs versus multiple inhaler triple therapies (MITTs).

METHODS:

SKOPOS-MAZI was a retrospective comparative effectiveness study in patients with COPD aged ≥40 years using US administrative claims data from Optum's deidentified Clinformatics® Data Mart Database. The primary and secondary endpoints were time to all-cause mortality and time to first severe cardiopulmonary event following initiation of BGF or MITT (identification period: October 1, 2020-June 30, 2023; index date: first prescription fill). Relative hazards of outcomes were assessed until a censoring event using Cox proportional hazards models, with inverse propensity treatment weighting accounting for between-group imbalances (standardized mean difference >0.1) in baseline characteristics.

RESULTS:

In the primary cohort, risk (hazard ratio [95% confidence intervals]) of all-cause mortality and a first severe cardiopulmonary event were 18% (0.82 [0.75, 0.91]) and 12% (0.88 [0.83, 0.93]) lower in patients initiating BGF versus MITT; results were consistent across censoring definitions, landmark periods, and sensitivity cohorts.

CONCLUSION:

In this real-world comparative effectiveness study of patients with COPD initiating BGF or MITT, BGF was associated with lower all-cause mortality and severe cardiopulmonary event risk versus MITT after accounting for between-group differences in baseline sociodemographic and clinical characteristics. This study supports the benefits of BGF over MITT and the need to consider proactive use of SITTs in COPD management.

News (Medical) associated with Budesonide/Formoterol fumarate/Glycopyrronium Bromide

25 Jul 2025

·www.astrazeneca.com

Trixeo Aerosphere receives positive EU CHMP opinion as first inhaled medicine using next-generation propellant with near-zero Global Warming Potential

AstraZeneca’s Trixeo Aerosphere (budesonide/glycopyrronium/formoterol fumarate or BGF), already licensed for the treatment of chronic obstructive pulmonary disease (COPD) in adults, has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency, endorsing it for use in the European Union (EU) with an innovative, next-generation propellant with near-zero Global Warming Potential (GWP).1 Trixeo is the first medicine delivered by a pressurised metered-dose inhaler (pMDI) using a propellant that offers 99.9% lower GWP than propellants used in currently available pMDIs.2 This fixed-dose triple-combination therapy, marketed as Breztri Aerosphere in the US, China and Japan, will now have a low carbon footprint comparable to inhaled medicines that do not require a propellant.3 Based on the CHMP positive opinion, AstraZeneca will now begin to transition its Trixeo supply to the next-generation propellant in Europe. The CHMP positive opinion is based on results from the next-generation propellant clinical development programme, which demonstrated bioequivalence between Trixeo with the next-generation propellant and Trixeo with the current propellant.4,5 The safety and tolerability profile for Trixeo with the next-generation propellant was consistent with the known profile of the medicine. Frederik Trinkmann, Professor and Senior Pulmonologist at the Thoracic Clinic at Heidelberg University Hospital, Germany, said: “Respiratory medicines delivered by pressurised metered-dose inhalers are essential for millions of people living with respiratory diseases in Europe, including specific vulnerable populations such as children and the elderly. The transition of Trixeo to the propellant with near-zero Global Warming Potential ensures clinicians’ treatment decisions can focus on clinical needs while also supporting environmental goals.” Ruud Dobber, Executive Vice President, BioPharmaceuticals Business Unit, AstraZeneca, said: “The CHMP positive opinion of Trixeo Aerosphere with the next-generation propellant allows us to address the needs of both patients and the planet and is a significant milestone in our commitment to delivering innovations for sustainable healthcare in the EU. Starting with Trixeo, the transition to the near-zero Global Warming Potential propellant across our pressurised metered-dose inhaled respiratory medicines is an important step towards achieving our Ambition Zero Carbon strategy.” Susanna Palkonen, Director of the European Federation of Allergy and Airways Diseases Patients' Associations, said: “COPD is a devastating disease and the third leading cause of mortality in the world. People living with COPD need access to a treatment which is right for them as well as a healthy environment and clean air. We welcome the positive opinion from the CHMP for the inhaled respiratory medicine containing the next-generation propellant with a significantly reduced carbon footprint.” Trixeo with the next-generation propellant received its first approval in the UK in May 2025 with regulatory applications also currently under review in China and additional countries. Trixeo is the first medicine in AstraZeneca’s portfolio of medicines delivered by pMDIs to transition to the new propellant. AstraZeneca aims to transition its wider pMDI portfolio to the near-zero GWP propellant by 2030 as part of the Company’s Ambition Zero Carbon strategy. In the EU, the Company plans to initiate the transition of Trixeo to the next-generation propellant in the coming months. Chronic respiratory diseases, including COPD, affect hundreds of millions of people around the world.6 Respiratory inhaled medicines delivered by pMDIs account for 76% of all inhaler use in Europe, and contribute 0.04% of global greenhouse gases.7,8 Studies show that the largest environmental contribution from respiratory diseases comes from patients’ symptoms not being adequately controlled and resulting increased healthcare utilisation.9,10 Implementing evidence-based guidelines into clinical practice can reduce exacerbations and unscheduled healthcare utilisation, and the resulting improved patient outcomes may also decrease the overall carbon footprint associated with respiratory care.11 Notes AstraZeneca’s next-generation propellant clinical development programme The clinical development programme has been initiated to assess the efficacy and safety of the next-generation, near-zero Global Warming Potential propellant with the AstraZeneca portfolio of inhaled medicines delivered by pressurised metered-dose inhalers (pMDIs). The first medicine to be assessed in the programme was Breztri/Trixeo Aerosphere (budesonide/glycopyrronium/formoterol fumarate or BGF) through in vitro, in vivo bioequivalence (PK), safety and efficacy clinical studies.12-17 The programme established bioequivalence between Breztri/Trixeo with the next-generation propellant and Breztri/Trixeo with the current propellant.4,5 The safety and tolerability profile for Breztri/Trixeo with the next-generation propellant was consistent with the known profile of the medicine. Additional studies are underway to assess the bioequivalence of the next-generation propellant to the current propellant with AstraZeneca’s other medicines delivered by pMDIs. Breztri/Trixeo Aerosphere Budesonide/glycopyrronium/formoterol fumarate (BGF), approved under the brand name Trixeo Aerosphere in the EU and UK and Breztri Aerosphere in Japan, China and the US, is a single-inhaler, fixed-dose triple-combination of formoterol fumarate, a long-acting β2 agonist (LABA), glycopyrronium bromide, a long-acting muscarinic antagonist (LAMA), with budesonide, an inhaled corticosteroid (ICS), and delivered via the Aerosphere pMDI. Breztri/Trixeo Aerosphere is approved to treat COPD in more than 80 countries worldwide including the US, EU, China, Japan, and has been prescribed to more than five million patients globally. Breztri/Trixeo Aerosphere with the next-generation propellant will maintain the same indication, product strength and dosage regimen as Breztri/Trixeo Aerosphere with the current propellant. AstraZeneca’s Collaboration with Honeywell Developed by Honeywell, the medical grade version of the next-generation propellant is critical to enable the transition of pMDI medicines with reduced climate impact, given its near-zero GWP. AstraZeneca announced in 2022 its collaboration with Honeywell to develop respiratory inhaled medicines using the new propellant. Ambition Zero Carbon Through its Ambition Zero Carbon strategy, AstraZeneca is pursuing bold, science-based decarbonisation targets, accelerating progress towards net zero. AstraZeneca was one of the first seven companies globally to have its net zero targets verified by the Science-Based Targets initiative (SBTi) Corporate Net-Zero Standard. 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/Nasdaq: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialisation 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.com and follow the Company on social media @AstraZeneca. Contacts For details on how to contact the Investor Relations Team, please click here. For Media contacts, click here. References Corporate and financial

Drug Approval

10 Jul 2025

·endpoints.news

Updated: FDA publishes repository of 200+ drug rejection letters, promising more in the future

In a historic first, the FDA on Thursday released about 200 novel and generic drug rejection letters, bucking the agency’s former reticence to publicize the documents in one place. But it’s a small step as nearly all the letters reviewed by Endpoints News were previously disclosed as part of the drugs’ approval packages. Two of the complete response letters not previously disclosed included one for AstraZeneca’s COPD treatment Breztri Aerosphere in 2019 and one for a label update for Astellas’ eye drug Izervay in 2024. All of the rejection letters released are for drugs that have since been approved. AstraZeneca disclosed its CRL in a press release but did not mention that the FDA said the submitted data “do not provide substantial evidence of the efficacy and safety for the use of Breztri Aerosphere.” The CRL also said “the single Aerosphere phase 3 pivotal trial failed on the co-primary endpoint of change from baseline in trough FEV1 for the comparison of Breztri Aerosphere and the glycopyrrolate and formoterol fumarate combination.” AstraZeneca said in a statement to Endpoints that its 2019 press release on the Breztri complete response letter “is an accurate reflection of the status of the regulatory filing and data at the time.” Breztri was later approved in 2020 following submission of additional data. For Izervay’s label expansion, Astellas also announced the CRL in a press release in 2024, but said the FDA comments outlined in the CRL “focus on a statistical matter” and “are unrelated to the safety and benefit/risk of the use of IZERVAY.” The FDA, however, said in the CRL that the company’s proposal to extend the dosing interval “was not supported by the submitted data and was not replicated in a second adequate and well controlled study.” Astellas did not immediately respond to a request for comment. The FDA noted that according to a 2015 analysis conducted by FDA researchers, drug companies “avoided mentioning 85% of the FDA’s concerns about safety and efficacy when announcing publicly that their application was not approved. Moreover, when FDA calls for a new clinical trial for safety or efficacy, that critical information is not disclosed approximately 40% of the time.” The FDA said the CRLs have been redacted for trade secrets and confidential commercial information. It’s unclear if the agency contacted the sponsors prior to releasing the new letters. The agency also said it is in the process of publishing additional CRLs from its archives. “For far too long, drug developers have been playing a guessing game when navigating the FDA,” FDA Commissioner Marty Makary said in a statement. “Drug developers and capital markets alike want predictability. So today we’re one step closer to delivering it to them, with an ultimate goal of bringing cures and meaningful treatments to patients faster.” Editor’s Note: This story was updated with comment from AstraZeneca. An earlier version was updated to reflect a review of the documents released today, finding that some were previously disclosed in approval packages.

Phase 3Drug Approval

09 Jul 2025

·www.fiercepharma.com

Respiratory pharma royalty rally around rural COPD education and support drive

The Lung Association is expanding access to the free Lung Health Navigator program. A who’s who of respiratory disease drug developers has backed the American Lung Association’s push to help chronic obstructive pulmonary disease (COPD) patients in rural communities. Sanofi and Regeneron, AstraZeneca, Roche’s Genentech and GSK have provided support for the Living Well with COPD educational campaign. The support will equip the Lung Association to work with rural partners and referral networks, plus local healthcare providers, to deliver services and education to COPD patients.The Lung Association created the campaign for all families across the U.S. affected by COPD, but has paid particular attention to people in rural communities. COPD rates are higher in rural communities than urban areas, the nonprofit said, and patients may lack easy access to hospitals and other resources. To address the health equity challenge, the Lung Association is expanding access to the free Lung Health Navigator program. The program connects COPD patients to licensed healthcare professionals, either via a phone call, online chat or video meeting. Patients receive free, one-to-one support. The Lung Association said it is sharing educational materials to help patients “improve communication with their healthcare provider, better understand available COPD treatments and improve their quality of life.” In parallel, the nonprofit is supporting healthcare providers to improve awareness of COPD therapy options.All of the companies that supported the campaign have COPD therapies. Sanofi and Regeneron received FDA approval for Dupixent in the indication last year. The COPD launch got off to a promising start, but the companies’ IL-33 prospect suffered a phase 3 blow in May. Genentech also has an IL-33 candidate. AstraZeneca’s rival IL-33 prospect failed a phase 2 trial last year but development is continuing.AstraZeneca already sells Breztri Aerosphere, an inhaler that competes with GSK’s Trelegy Ellipta for the COPD market. GSK recently won FDA approval for its IL-5 antibody Nucala in COPD. Nucala became the third biologic approved in COPD after Dupixent and Verona Pharma’s Ohtuvayre. Merck & Co. is reportedly closing in on a $10 billion deal to buy Verona.

Drug ApprovalPhase 3AcquisitionPhase 2

100 Deals associated with Budesonide/Formoterol fumarate/Glycopyrronium Bromide

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	R03AL11	-

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Bronchitis, Chronic	Japan	AstraZeneca KK	18 Jun 2019
Pulmonary Disease, Chronic Obstructive	Japan	AstraZeneca KK	18 Jun 2019
Pulmonary Emphysema	Japan	AstraZeneca KK	18 Jun 2019

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Moderate chronic obstructive pulmonary disease	Phase 3	United States	AstraZeneca Investment (China) Co. Ltd.	20 Aug 2015
Moderate chronic obstructive pulmonary disease	Phase 3	United States	AstraZeneca Dunkerque Production SCS	20 Aug 2015
Moderate chronic obstructive pulmonary disease	Phase 3	United States	Pearl Therapeutics, Inc.	20 Aug 2015
Moderate chronic obstructive pulmonary disease	Phase 3	Japan	Pearl Therapeutics, Inc.	20 Aug 2015
Moderate chronic obstructive pulmonary disease	Phase 3	Japan	AstraZeneca Investment (China) Co. Ltd.	20 Aug 2015
Moderate chronic obstructive pulmonary disease	Phase 3	Japan	AstraZeneca Dunkerque Production SCS	20 Aug 2015
Moderate chronic obstructive pulmonary disease	Phase 3	Canada	AstraZeneca Investment (China) Co. Ltd.	20 Aug 2015
Moderate chronic obstructive pulmonary disease	Phase 3	Canada	AstraZeneca Dunkerque Production SCS	20 Aug 2015
Moderate chronic obstructive pulmonary disease	Phase 3	Canada	Pearl Therapeutics, Inc.	20 Aug 2015
Severe chronic obstructive pulmonary disease	Phase 3	United States	AstraZeneca Dunkerque Production SCS	20 Aug 2015

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05477108 (CTgov)	Phase 1	Pulmonary Disease, Chronic Obstructive	108	BGF (Treatment A)	opcuureqhr(intvybjvzf) = blitryztif pgnzkhsisb (deubuycdjo, 61.09) View more	-	28 May 2025
				BGF (Treatment B (Replicate 1))	opcuureqhr(intvybjvzf) = dxhcqkkedo pgnzkhsisb (deubuycdjo, 63.42) View more
MITOS EROS+CP (US) Study (ATS2025)	Not Applicable	Asthma-Chronic Obstructive Pulmonary Disease Overlap Syndrome	8,837	Prompt initiation of Budesonide/Glycopyrrolate/Formoterol Fumarate (BGF)	oyspuqoqel(ftjlcievos) = vzchxrviqk hhyikukgib (rxxsyteogg, 1.30 - 1.45)	Positive	16 May 2025
				Delayed initiation of Budesonide/Glycopyrrolate/Formoterol Fumarate (BGF)	oyspuqoqel(ftjlcievos) = xnmobftlcb hhyikukgib (rxxsyteogg, 1.85 - 1.94)
NCT04609904 (LOGOS, Company_Website) Manual	Phase 3	Asthma	-	Breztri Aerosphere	ivqwhfjpax(xnehmbxkpi) = met all primary endpoints exzxrjiouk (ewjxamsidg ) Met	Positive	02 May 2025
				Budesonide and formoterol fumarate (BFF) MDI 320/9.6 μg
NCT04609878 (KALOS, Company_Website) Manual	Phase 3	Asthma	-	Breztri Aerosphere	bjoeupijpf(hzgjnkabtj) = met all primary endpoints sjmgfvonei (iiojozxpem ) Met	Positive	02 May 2025
				Budesonide and formoterol fumarate
NCT05569421 (CTgov)	Phase 1	Pulmonary Disease, Chronic Obstructive	108	BAB+BGF (Treatment A)	npsejjxyyt(iarbyblixl) = nrpzmbqonn uqbikmnfav (pjcomxlaef, 46.71) View more	-	29 Apr 2025
				BAB+BGF (Treatment B (Replicate 1))	npsejjxyyt(iarbyblixl) = nhnwwftiom uqbikmnfav (pjcomxlaef, 40.78) View more
NCT05472350 (Pubmed \| Transl Lung Cancer Res)	Not Applicable	Cough	-	Budesonide/glycopyrronium/formoterol fumarate co-suspension metered dose inhaler (BGF MDI)	brhipchqeq(uoyrmztavh) = Three participants in the BGF MDI group reported palpitations, with no other complications noted cqgcouzseh (bgrdptalrf ) View more	Positive	01 Apr 2025
				Budesonide/glycopyrronium/formoterol fumarate co-suspension metered dose inhaler (Control group)
ATS2024	Not Applicable	Pulmonary Disease, Chronic Obstructive	-	Budesonide/Glycopyrrolate/Formoterol (BGF)	wsoywvyhjf(jkljpztxas) = qpljhfksdz ivreixwynn (yjscveidpn )	-	19 May 2024
				Multiple Inhaler Triple Therapy (MITT)	wsoywvyhjf(jkljpztxas) = fkcrrgyxxo ivreixwynn (yjscveidpn )
ATS2023	Not Applicable	Pulmonary Disease, Chronic Obstructive	-	Prompt BGF initiation (≤30 days)	eozsdxpnpo(jbjqxrdafb) = fhqhrbvmqb iojwefizag (aouemxglwk, 0.04 - 0.09) View more	-	21 May 2023
				Delayed BGF initiation (31-180 days)	eozsdxpnpo(jbjqxrdafb) = htddyuqbcq iojwefizag (aouemxglwk, 0.06 - 0.10) View more
ATS2023	Not Applicable	Pulmonary Disease, Chronic Obstructive	-	Budesonide/Glycopyrrolate/Formoterol Fumarate (BGF)	mmwpvlwoiy(miklpkuasi): HR = 0.61 (95% CI, 0.38 - 0.95), P-Value = 0.030	-	21 May 2023
				Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI)
NCT02497001 (Pubmed \| Appl Health Econ Health Policy)	Phase 3	Severe chronic obstructive pulmonary disease	1,902	Budesonide/Glycopyrrolate/Formoterol Fumarate (BGF)	cvohhnedfd(stzwavausn) = plbbooiwan avqwhvxkvn (fgyuqsvdre ) View more	-	01 Sep 2022
				Long-acting muscarinic antagonist/long-acting β2-agonist (LAMA/LABA)	cvohhnedfd(stzwavausn) = vgndcsmlft avqwhvxkvn (fgyuqsvdre ) View more

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