A prospective cohort study for constructing a predictive model of airway reactivity in cough variant asthma and verifying the efficacy differences of different ICS/LABA treatments

Start Date10 Jun 2026

Sponsor / Collaborator-

NCT07433569

/ CompletedPhase 1

Phase I Study to Compare the Pharmacokinetics of Budesonide and Formoterol Delivered With Symbicort Aerosphere® and Symbicort® pMDI in Children 4 to Less Than 12 Years of Age With Asthma

The purpose of this study is to assess the pharmacokinetics (PK) and safety of symbicort aerosphere and symbicort pressurized metered dose inhaler (pMDI) in participants with asthma aged 4 to less than 12 years.

Start Date05 Mar 2026

Sponsor / Collaborator

AstraZeneca PLC

100 Clinical Results associated with Budesonide/Formoterol Fumarate Dihydrate

100 Translational Medicine associated with Budesonide/Formoterol Fumarate Dihydrate

100 Patents (Medical) associated with Budesonide/Formoterol Fumarate Dihydrate

484

Literatures (Medical) associated with Budesonide/Formoterol Fumarate Dihydrate

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 ; Shah, Mihir ; Jackson, David J ; Papi, Alberto ; Obasi, Chidi ; Helman, Jesse ; Bowen, Karin ; Wise, Robert A ; 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 Apr 2026·JOURNAL OF ETHNOPHARMACOLOGY

Bufei formula attenuates airway mucus hypersecretion in COPD through inhibition of TRIM56-mediated ITGB4 ubiquitination

Article

Author: Zhang, Qin ; Cheng, Mengmeng ; Wei, Yanxin ; Zhao, Di ; Zhao, Peng ; Xin, Nan ; Li, Jiansheng ; Zhang, Zeyu

ETHNOPHARMACOLOGICAL RELEVANCE:

Bufei Formula (BFF), a traditional Chinese medicine, has been widely utilized in the clinical treatment of chronic obstructive pulmonary disease (COPD), though its underlying mechanisms remain unclear and warrant further investigation.

AIM OF THE STUDY:

To investigate the mechanisms by which BFF alleviates COPD airway mucus hypersecretion through the TRIM56-mediated ubiquitination.

MATERIALS AND METHODS:

A cigarette smoke-induced COPD mouse and cigarette smoke extract (CSE)-induced airway epithelial cells were established to evaluate the effect of BFF on airway mucus hypersecretion. The target protein of BFF was identified using DARTS technology. Co-immunoprecipitation (Co-IP) combined with mass spectrometry (MS) was used to identify the downstream proteins of TRIM56.

RESULTS:

BFF can effectively improve lung function and pathological changes, and inhibit inflammation in COPD mice, as well as downregulate the levels of mucin and MUC5AC in the lung. BFF-4, an active fraction derived from BFF, directly inhibits the expression of MUC5AC and TNF-α induced by CSE in epithelial cells. DARTS analysis and single-cell sequencing analysis revealed that TRIM56 is a target of BFF-4, and its mediated ubiquitination contributes to the effects of BFF-4. Moreover, high levels of TRIM56 and ubiquitinated proteins are expressed both in vivo and in vitro. BFF-4 significantly downregulates these expressions. Furthermore, overexpression of TRIM56 and ubiquitinated proteins markedly diminishes the inhibitory effect of BFF-4 on mucin expression. Overexpression of TRIM56 also counteracts the inhibition of ubiquitination by BFF-4. Co-IP-MS analysis revealed that TRIM56 binds to ITGB4, which in turn regulates the expression of MUC5AC. Furthermore, molecular docking identified the top five small molecules with the highest affinity for TRIM56 were identified, suggesting their potential for direct interaction with TRIM56.

CONCLUSION:

BFF-4 effectively ameliorates airway mucus hypersecretion in COPD by inhibiting TRIM56-mediated downregulation of protein ubiquitination, including ITGB4.

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 Budesonide/Formoterol Fumarate Dihydrate

30 Jul 2026

·www.astrazeneca.com

AstraZeneca’s fixed-dose triple-combination Trixeo Aerosphere (budesonide/glycopyrronium/formoterol fumarate or BGF (320/28.8/9.6μg)) has been recommended for approval in the European Union (EU) for the maintenance treatment of asthma in patients 12 years of age and older who are not adequately controlled by a combination of a medium dose inhaled corticosteroid (ICS) and long-acting beta2-agonist (LABA). Trixeo Aerosphere, marketed as Breztri Aerosphere in the US, China and Japan,is a single inhaler that combines the efficacy of ICS/LABA with a long-acting muscarinic antagonist (LAMA). The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) based its positive opinion on results from the KALOS and LOGOS Phase III trials, in which Trixeo demonstrated statistically significant improvements in lung function compared with combined ICS/LABA comparators.1 In the pooled analysis of KALOS and LOGOS, Trixeo demonstrated a statistically significant reduction in the annualised rate of severe asthma exacerbations versus combined ICS/LABA comparators in a broad population of patients including those with no asthma exacerbations in the previous year.1 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: “Across Europe, millions of people with asthma still experience reduced lung function, breathing difficulties, exacerbations and significant disruption to daily life due to uncontrolled disease. The CHMP positive opinion for Trixeo represents an important step forward, offering a potential new treatment option that could help reduce exacerbations and improve disease control for patients living with asthma independent of their prior exacerbation history.” Ruud Dobber, Executive Vice President, BioPharmaceuticals Business Unit, AstraZeneca, said: “Building on the recent FDA approval for Breztri/Trixeo in asthma, we are pleased by the positive CHMP recommendation, which underscores the potential of this fixed-dose triple-combination therapy to improve outcomes for patients in Europe who continue to experience uncontrolled disease. The continued momentum of Trixeo across both asthma and COPD reflects our ambition to help transform respiratory care by delivering meaningful improvements in treatment outcomes by reducing the risk of exacerbations for patients.” In a key secondary endpoint, Trixeo demonstrated a rapid onset of action with a significant improvement from baseline in lung function within five minutes after the first dose.1 Trixeo is a maintenance therapy and is not used to relieve sudden breathing problems and will not replace a rescue inhaler. Results from KALOS and LOGOS were published in The Lancet Respiratory Medicine in February 2026.1 There were no new safety or tolerability signals identified for Trixeo in the trials.1 In Europe, there are nearly 43 million people living with asthma, and every year, about four million more people are newly diagnosed.2 When uncontrolled on dual therapies, patients can often struggle with symptoms such as wheezing, breathlessness, coughing exacerbations and even death.3-5 Trixeo/Breztri, is approved in the US for treatment of asthma, with regulatory filings currently under review in other major regions, including Japan and China. Trixeo/Breztri is also approved for the treatment of COPD in adults in 90 countries worldwide including the US, EU, China and Japan. Notes Asthma Asthma is a prevalent, chronic respiratory disease affecting as many as 363 million people worldwide,including nearly 43 million people in Europe.2,6 Around half of patients continue to be uncontrolled on dual therapies, leading to inflammation and muscle tightening in the airway (bronchoconstriction) that cause wheezing, breathlessness, chest tightness, coughing exacerbations and even death.3-5 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.4,5 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/Trixeo Aerosphere 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.7,8 In the data package submitted to the EMA, in the individual trials, the primary lung function endpoint was change from baseline in morning pre-dose trough FEV1 over 24 weeks, and the key secondary endpoint was change from baseline in FEV1 AUC0-3 over 24 weeks, versus dual therapy (the ICS/LABA treatment groups combined).1 The pooled primary endpoint using data from both KALOS and LOGOS trials, and prioritised in the testing procedure, was the rate of severe asthma exacerbations versus dual therapy (ICS/LABA) treatment groups combined.1 The primary and secondary endpoints and treatment comparisons in the KALOS and LOGOS trials differed according to regulatory submission approaches.1 Breztri/Trixeo Aerosphere Budesonide/glycopyrronium/formoterol fumarate or budesonide/glycopyrrolate/formoterol fumarate, is approved under the brand name Breztri Aerosphere in Japan, China and the US, and Trixeo 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 is approved in the US to treat asthma in patients 12 years of age and older. Regulatory filings for Breztri/Trixeo in asthma are currently under review in all other major regions. Breztri/Trixeo is also approved for the treatment of COPD in more than 90 countries worldwide including the US, EU, China, Japan, and was prescribed to more than 6.8 million patients globally in 2025.9 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 commercialisation of prescription medicines in Oncology, Rare Disease, 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

Phase 3Clinical ResultDrug Approval

27 Jul 2026

·www.fiercepharma.com

AZ stays on track for $80B revenue goal as cancer meds, rare disease sales help offset Ultomiris miss

Even as trial setbacks and pipeline adjustments rear their heads, AstraZeneca feels confident that its core business is on track to support the $80 billion revenue goal it’s set for 2030. And on the more existential topics of China competition, U.S. drug pricing reform and the potential need for an external pipeline refresh, AZ’s top brass is keeping its cool. In 2026’s second quarter, the British Big Pharma generated revenue of nearly $15.4 million, growing 5% over the same period in 2025 at constant exchange rates. With the first act of 2026 now in the books, AZ is reporting total revenue of $30.7 billion, up some 6%, driven primarily by sales in oncology, rare disease and respiratory and immunology, which each grew over the first half of the year, even as total biopharma earnings dropped for the six-month period thanks to a hit in infectious disease. Among the high-grossing cancer unit, TKI lung cancer med Tagrisso remained AZ’s top earner with Q2 sales of $1.94 billion and a first-half-of-2026 haul amounting to nearly $3.8 billion, followed closely by PD-L1 blockbuster Imfinzi, which brought home $1.85 billion and $3.55 billion for Q2 and the first six months of 2026, respectively. Major multi-billion-dollar sales hauls for the second quarter and first half of the year were also posted by Farxiga in AZ’s cardiovascular category, plus Symbicort and Fasenra in the respiratory and immunology segment and Ultomiris from the rare disease portfolio, with the latter drug growing 12% to $1.31 billion for the quarter. While an improvement year-over-year, that performance fell short of analysts' expectations by around $24 million, according to a note from Jefferies Monday. Adding to that dent in Ultomiris’ quarterly report card, AZ revealed early Monday that a phase 3 trial pitting the drug against placebo in teens and adults with thrombotic microangiopathy after hematopoietic stem cell transplant had failed to hit statistical significance on the primary endpoint of event-free survival through 26 weeks. Thrombotic microangiopathies (TMAs) are rare and potentially lethal disorders that cause blood clots and damage to the walls of the smallest blood vessels in the circulatory system, and AZ had been testing Ultomiris in a type of the condition that occurs after hematopoietic stem cell transplant to treat cancer and other diseases. Still, AZ noted that its Alexion rare disease unit has nevertheless seen clinically meaningful results around overall survival in its pediatric trial and continues to advance filings on Ultomiris in that indication. The Ultomiris slip follows other phase 3 misses from AZ drugs in the period, including for Imfinzi in adjuvant hepatocellular carcinoma and Wainua in ATTR-CM. Separately, AZ revealed in its earnings report that it has scrapped two in-house antibody-drug conjugate (ADC) candidates that underperformed in the clinic. Nevertheless, executives told Fierce on a media call earlier Monday that they remain “very confident” in the company’s roster of investigational ADCs overall. When pressed on an analyst call whether AZ needs to lean on M&A activity to bolster its late-stage pipeline—especially as the company heads for a significant patent expiration period early in the next decade—CEO Pascal Soriot said in no uncertain terms that “the answer is no: We don’t need more BD to deliver.” Soriot emphasized that his confidence doesn’t come from any one single asset but the company’s phase 3 pipeline in aggregate, noting that AZ tracks its overall chance of phase 3 success at “around 60%,” which he noted was a bit lower than the industry average and below AZ’s historic track record of “75%-plus.” “The reason we don’t need more BD is really to continue planning long-term and continuously strengthen our franchises,” the CEO explained, pointing to Tagrisso as one example of a product worth investing in internally rather than rushing out to acquire a new asset. AstraZeneca’s overall second quarter earnings were in line with expectations, the Jefferies analysts pointed out Monday, noting that outsized Q2 performances from hypophosphatasia drug Strensiq (up 36% at $536 million) lymphoma and leukemia med Calquence (up 16% $1.02 billion) and asthma treatment Tezspire (up 45% $390 million) helping counter misses from Tagrisso and Lynparza, as well as AZ’s asthma rescue inhaler Airsupra ($50 million Q2), which “continues to lag,” in the Jefferies team’s estimation. With less than six months to go before the year is out, AZ is sticking to the previous guidance range, which anticipates a mid-to-high single-digit percentage revenue increase over 2025 at constant currencies. Moreover, the company reiterated that it’s confident in the $80 billion revenue target it has pledged to deliver in 2030. In reflecting on Tagrisso, Soriot also touched on the matter of China, where AZ has continued to commit resources heavily even as hawkishness around competition with the country mounts in places like the U.S. But in the CEO’s estimation, this deep relationship is exactly what positions AstraZeneca well to compete as the international biopharma landscape continues to evolve. “If you don’t have a very strong domestic business from a profit viewpoint, it’s not that simple to globalize,” Soriot said of the current China biotech dynamic. “But you have to assume they will at some point.” “What we’re doing,” he continued, “is collaborating, but we’re also competing. You saw the competition in the Tragrisso market is very, very intense, and in the ADC market very intense too. So, we learn to compete with them, and certainly we’ll take those learnings globally when they become global companies, if they do.” Soriot added that “We’re also learning from [China biotechs] in terms of how they develop products and how fast they operate. And we’ve made some changes in the way we operate.”

Phase 3ADC

08 Jul 2026

·www.fiercebiotech.com

AstraZeneca pens $2.1B Sino deal for challenger to Merck’s COPD drug Ohtuvayre

AstraZeneca is paying Sino Biopharmaceutical $200 million upfront for ex-China rights to a late-phase challenger to Merck & Co.’s chronic obstructive pulmonary disease (COPD) drug Ohtuvayre. The deal, which includes (PDF) up to $1.9 billion in milestones, covers a PDE3/4 inhibitor, TQC3721. Sino, working through its Chia Tai Tianqing Pharmaceutical subsidiary, has advanced a nebulized formulation of the drug candidate into phase 3 development in China. A dry powder inhaler formulation is in phase 2 and Sino has hailed TQC3721 as a potential best-in-class asset after posting mid-stage data on the candidate. Merck’s Ohtuvayre has set the benchmark in the PDE3/4 class. When the U.S. pharma acquired Ohtuvayre last year in its $10 billion buyout of Verona Pharma, Merck CEO Robert Davis said the asset has “multibillion-dollar peak commercial potential.” Ohtuvayre generated revenue of $131 million in the first quarter. While Merck is racing to accelerate Ohtuvayre growth, AstraZeneca has spotted an opportunity to crash the PDE3/4 party. TQC3721 improved peak FEV1, a measure of lung function, by up to 147 mL at Week 4 of a phase 2 trial. For comparison, Verona reported improvements of up to 124 mL in a phase 2 study. Verona published its phase 2 data in 2020 and won FDA approval for Ohtuvayre in 2024. AstraZeneca can draw on its COPD experience and expertise as it works to close the gap on Ohtuvayre. The U.K.-based pharma sells Symbicort and Breztri in indications including COPD, generating (PDF) sales of $1.2 billion from the drugs in the first quarter. TQC3721 will join a pipeline of next-generation COPD drug candidates in development at AstraZeneca. In March and April , the company reported positive phase 3 data on its anti-IL-33 antibody tozorakimab, which it plans to send to regulators. AstraZeneca is also running a phase 2 trial of an IRAK4 inhibitor, AZD6793, in COPD. The Sino deal also gives AstraZeneca exclusive global rights to certain future development programs.

Phase 2Clinical ResultLicense out/inPhase 3Acquisition

100 Deals associated with Budesonide/Formoterol Fumarate Dihydrate

External Link

KEGG	Wiki	ATC	Drug Bank
D09595	Budesonide/Formoterol Fumarate Dihydrate	R03AK07	-

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Mild asthma	United Kingdom	AstraZeneca PLC	23 Mar 2023
Asthma	Australia	AstraZeneca Pty Ltd.	27 May 2002
Pulmonary Disease, Chronic Obstructive	Australia	AstraZeneca Pty Ltd.	27 May 2002

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Childhood asthma	Phase 3	France	AstraZeneca PLC	23 Aug 2021
Asthma chronic	Phase 3	United States	Teva Pharmaceuticals USA, Inc.	13 Jan 2017
Ciliary Motility Disorders	Phase 3	United States	AstraZeneca PLC	01 Jan 2007
Neonatal Sepsis	Phase 3	Denmark	AstraZeneca PLC	01 May 2005
Neonatal Sepsis	Phase 3	France	AstraZeneca PLC	01 May 2005
Neonatal Sepsis	Phase 3	Germany	AstraZeneca PLC	01 May 2005
Neonatal Sepsis	Phase 3	Spain	AstraZeneca PLC	01 May 2005
Neonatal Sepsis	Phase 3	Sweden	AstraZeneca PLC	01 May 2005
Neonatal Sepsis	Phase 3	United Kingdom	AstraZeneca PLC	01 May 2005
airway disease	Phase 3	Sweden	AstraZeneca PLC	01 Oct 2004

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01117116 (CTgov)	Not Applicable	Asthma	20	budesonide and formoterol+fluticasone propionate and salmeterol (Fluticasone Propionate and Salmeterol)	nruryjbtxw(hafcfockba) = kwumovqqvh stdhxcpvqu (stmnhxzaav, pmqrdpzrzf - qtehvzqsxy) View more	-	06 Jul 2026
				budesonide and formoterol+fluticasone propionate and salmeterol (Budesonide and Formoterol)	nruryjbtxw(hafcfockba) = ucchawaztu stdhxcpvqu (stmnhxzaav, pxowvmbinp - wcxjhiblru) View more
Pubmed \| Indian J Pediatr	Not Applicable	Persistent asthma	84	SMART with inhaled budesonide-formoterol combination	tdglazuofm(hfcqlzxnjl) = paihkwihwo satqufjsgk (vpmlcywdzy, 10 - 20) View more	Positive	01 Feb 2026
				budesonide plus as-needed levo-salbutamol	tdglazuofm(hfcqlzxnjl) = zcajzwjbdx satqufjsgk (vpmlcywdzy, 8.5 - 15.5) View more
NCT05755906 (LITHOS, CTgov)	Phase 3	Asthma	374	BFF MDI (BFF MDI 160/9.6 μg)	ktclrkrvhz(nwapznhlks) = mmvshkxbks kozptyozqj (fkefntdsxn, 0.0235) View more	-	28 Jan 2026
				BD MDI (BD MDI 160 μg)	ktclrkrvhz(nwapznhlks) = hlrfqhweiq kozptyozqj (fkefntdsxn, 0.0241) View more
NCT06429475 (PACTR202502547023775, Pubmed \| BMJ Open Respir Res)	Phase 3	Asthma	360	Budesonide/formoterol inhaler	qfnhwnyuip(qihzeykchb) = bpepinufuu xffwddzzno (cuetuuqrst )	Positive	01 Nov 2025
				Standard of care (ICS and SABA)	qfnhwnyuip(qihzeykchb) = vzpgdbwjja xffwddzzno (cuetuuqrst )
NCT01167010 (UNIK, CTgov)	Phase 3	Asthma \| Persistent asthma	552	Formoterol/Budesonide (Formoterol/Budesonide)	dausxeodhe(khsrftebnv) = mqwdkimoss fcrgirbjko (ucxmktxnkr, 0.79) View more	-	01 May 2025
				Alenia (Alenia)	dausxeodhe(khsrftebnv) = vknmvxrhxq fcrgirbjko (ucxmktxnkr, 0.77) View more
NCT03924635 (CTgov)	Phase 4	Asthma \| airway disease	42	salbutamol+SYMBICORT (SYMBICORT as Maintenance and Reliever Treatment)	dhbfboxldq(wzzbiudvst) = uegdvdgzic dptqxxxwki (wakyrudmuk, ycjyyfravn - anpzhdggbm) View more	-	22 Jan 2025
				salbutamol+SYMBICORT (SYMBICORT as Maintenance, Salbutamol as Reliever Treatment)	dhbfboxldq(wzzbiudvst) = gnvvytnbnh dptqxxxwki (wakyrudmuk, eusjhwcpae - vecqxvgojf) View more
NCT04159519 (SHAMAL, CTgov)	Phase 4	Asthma \| Eosinophilic Asthma	170	salbutamol+Symbicort+benralizumab (Treatment Reduction)	ktqdohnsas = pegcnewgtm nhdsovyguc (dztpfarcgz, uxfoyzxbbs - gornhrxlvj) View more	-	09 Jan 2025
				salbutamol+Symbicort+benralizumab (Reference)	sybqsolbqb(wyjkrvxets) = quawsqyafx gncamebgye (eavpaoytlc, 0.0677) View more
CTR20180475 (CTR20180475, Pubmed \| COPD)	Phase 3	Pulmonary Disease, Chronic Obstructive	750	Beclometasone Dipropionate/Formoterol Fumarate	scdzfzytle(jhijzodrsc) = bntyyhzggi uxjohtuoiz (odnewlzxjb, -0.025 to 0.022)	Positive	31 Dec 2024
				Budesonide/Formoterol Fumarate	scdzfzytle(jhijzodrsc) = axaggdonaw uxjohtuoiz (odnewlzxjb, -0.024 to 0.022)
ATS2024	Not Applicable	Pulmonary Disease, Chronic Obstructive	-	Fluticasone Furoate/Umeclidinium/Vilanterol	rmmqrktqxq(diuhdqruvw) = ermdcldjsd cqhkchflvh (imimbubtgn )	-	19 May 2024
				Budesonide/Formoterol	rmmqrktqxq(diuhdqruvw) = bqkabfuimw cqhkchflvh (imimbubtgn )
NCT01803555 (CTgov)	Phase 3	Persistent asthma	605	SYMBICORT placebo+Budesonide/Formoterol SPIROMAX® (BF Spiromax)	thnrekpvhg(clwlourvrk) = dszsraznvo vjdyyvaoat (bipuliwobj, 2.754) View more	-	08 Dec 2023
				SPIROMAX Placebo+SYMBICORT® TURBOHALER® (Symbicort Turbohaler)	thnrekpvhg(clwlourvrk) = nqhynqystw vjdyyvaoat (bipuliwobj, 2.745) View more

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