Duaklir (aclidinium bromide/formoterol fumarate) / Azurity Pharma - LARVOL DELTA

Real-life effectiveness of aclidinium/formoterol in COPD control: preliminary results of the REDACT observational study (ERS 2025) - "After 12 weeks of treatment with aclidinium/formoterol a significant proportion of uncontrolled COPD patients achieved COPD control, with accompanying significant improvements in lung function and health status. Funding: Specialty Therapeutics."

Clinical • Observational data • Chronic Obstructive Pulmonary Disease • Immunology • Respiratory Diseases

ANTES B+ Clinical Trial (clinicaltrials.gov) - P4 | N=48 | Terminated | Sponsor: Fundacio Privada Mon Clinic Barcelona | N=1028 ➔ 48 | Trial completion date: Sep 2025 ➔ Jan 2025 | Recruiting ➔ Terminated | Trial primary completion date: Sep 2025 ➔ Jan 2025; Delays in the opening and activation of participating sites, and a low recruitment rate, with only 48 participants enrolled over the course of one year

Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

The effect of different inhaled corticosteroid and long-acting bronchodilator combinations on the airway microbiome in patients with severe chronic obstructive pulmonary disease: A randomized trial (MUSIC). (PubMed, Eur Respir J) - "Fluticasone/salmeterol 500 increased sputum but not upper airway bacterial loads. ICS withdrawal was poorly tolerated in severe COPD."

Journal • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Has FDA's Drug Development Tools Qualification Program Improved Drug Development? (PubMed, Ther Innov Regul Sci) - "The lengthy and unpredictable nature of the COA Qualification Program review timelines poses a risk for tool developers and sponsors intending to qualify a new COA, to use an existing COA or sponsors intending to qualify and use a new COA in the drug development process. Our findings show that, to date, the DDT Qualification Program has not significantly improved the inclusion of qualified COAs in clinical development plans to support regulatory decision-making and label claims, and therefore the impact of the pathway to facilitate the use of innovative tools has been limited. To improve the utility of this program, FDA should publicly share the timelines so participants can be better prepared to integrate into their development programs. Furthermore, FDA should clearly articulate how and when COAs can be used in drug development."

Journal • Cardiomyopathy • Cardiovascular • Chronic Obstructive Pulmonary Disease • Congestive Heart Failure • Heart Failure • Immunology • Pulmonary Disease • Respiratory Diseases

AVANT: Study to Assess Efficacy and Safety of Aclidinium Bromide and Aclidinium Bromide/Formoterol Fumarate in Stabile COPD Patients (clinicaltrials.gov) - P3 | N=1625 | Completed | Sponsor: AstraZeneca | N=1067 ➔ 1625

Enrollment change • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Comparison table: Inhaled drugs for treatment of COPD. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Drugs for COPD. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections • Tobacco Cessation

ANTES B+ Clinical Trial (clinicaltrials.gov) - P4 | N=1028 | Recruiting | Sponsor: Fundacio Privada Mon Clinic Barcelona | Not yet recruiting ➔ Recruiting

Enrollment open • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

ANTES B+ Clinical Trial (clinicaltrials.gov) - P4 | N=1028 | Not yet recruiting | Sponsor: Fundacio Privada Mon Clinic Barcelona

New P4 trial • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Network meta-analysis of the efficacy and safety of monoclonal antibodies and traditional conventional dichotomous agents for chronic obstructive pulmonary disease. (PubMed, Front Med (Lausanne)) - "Overall, except for Dupilumab, mAbs did not significantly improve FEV1 compared to traditional conventional dichotomous agents. Among all the interventions included, Aclidinium bromide/Formoterol (AB/FF) (SUCRA 97.7%) ranked highest, followed by Umeclidinium/vilanterol (UMEC/VI) (SUCRA 93.5%), and Glycopyrrolate Formoterol Fumarate (GFF) (SUCRA 84.7%)...Considering the improvement in FEV1 and its safety, the development of mAbs for COPD still holds significant clinical potential. PROSPERO, CRD42023452714."

Retrospective data • Review • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Is it preferable to administer a bronchodilator once- or twice-daily when treating COPD? (PubMed, Respir Med) - "Both LAMA and LABA must be rapid in their onset of action. Aclidinium/formoterol, a twice-daily combination, is, among the available LAMA/LABA combinations, the most studied in terms of impact on daytime and night-time symptoms."

Journal • Review • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Efficacy and safety of aclidinium/formoterol versus monotherapies and aclidinium versus placebo in Chinese and other asian patients with moderate-to-severe COPD: The AVANT phase 3 study. (PubMed, Respir Med) - "Improvements in St George's Respiratory Questionnaire total scores occurred for aclidinium/formoterol vs placebo (LS mean -4.0; 95% CI -6.7, -1.4; p = 0.003) and aclidinium vs placebo (LS mean -2.9; 95% CI -5.5, -0.3; p = 0.031). Aclidinium/formoterol and aclidinium monotherapy were well tolerated and safety findings were consistent with known profiles; rates of treatment-emergent (TE) adverse events (AEs) (aclidinium/formoterol: 54.8%; aclidinium: 47.4%; placebo: 53.9%), serious AEs (7.2, 7.9, and 7.8%, respectively) and AEs leading to discontinuation of study medication (2.3,1.5, and 2.2%, respectively) were similar between groups."

Journal • P3 data • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Cost-Effectiveness of Umeclidinium/Vilanterol (UMEC/VI) Versus Aclidinium/Formoterol (ACL/FOR) in Patients with COPD in the United Kingdom (ISPOR-EU 2023) - P4 | "In a UK NHS setting, treatment with UMEC/VI was predicted to improve health outcomes and be the dominant (lower costs and better outcomes) treatment option compared with ACL/FOR in patients with symptomatic COPD."

Clinical • Cost effectiveness • HEOR • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

The effect of different inhaled corticosteroids on airway bacterial load and the microbiome in COPD: a randomized controlled trial (ERS 2023) - "After a 4-week washout patients with COPD (FEV1 <50% predicted or ≥2 exacerbations per year) were randomized to one of 4 treatments: budesonide/formoterol 400/12 (BF), fluticasone/salmeterol 500 (FS500), fluticasone/salmeterol 250 (FS250) or aclidinium/formoterol (AF). Patients randomized to fluticasone/salmeterol at licensed doses had an increased bacterial load in sputum over time compared to budesonide/formoterol.; Epidemiology; Public health; Pulmonary rehabilitation; Cell and molecular biology; General respiratory patient care; Physiology; Imaging"

Clinical • Chronic Obstructive Pulmonary Disease • Immunology • Infectious Disease • Pneumonia • Pulmonary Disease • Respiratory Diseases

Airway smooth muscle area to predict steroid responsiveness in COPD patients receiving triple therapy (HISTORIC): a randomised, placebo-controlled, double-blind, investigator-initiated trial. (PubMed, Eur Respir J) - "Patients divided in groups A and B with high ASMC area (HASMC: >20% of the bronchial tissue area) and with low ASMC area (LASMC: ≤20% of the bronchial tissue area), respectively and followed a run-in period of 6 weeks on open-label triple inhaled therapy with aclidinium/formoterol/budesonide (ACL/FOR/BUD:400/12/400 mcg/bid)...In patients with HASMC, however, ACL/FOR/BUD significantly improved FEV, as compared to ACL/FOR/placebo p=0.020. Over 12 months, the difference of FEV change between the group of ACL/FOR/BUD and the group of ACL/FOR/placebo was 50.6 mL·year within the group of patients with LASMC and 183.0 mL·year within the group of patients with HASMC.COPD patients with ΗASMC respond better to ICS than patients with LASMC, suggesting that this type of histological analysis may predict ICS responsiveness in COPD patients receiving triple therapy."

Journal • Asthma • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Chronic Obstructive Pulmonary Disease Exacerbations and Pneumonia Hospitalizations Among New Users of Combination Maintenance Inhalers. (PubMed, JAMA Intern Med) - "Combination LAMA-LABA inhalers (aclidinium-formoterol, glycopyrronium-formoterol, glycopyrronium-indacaterol, tiotropium-olodaterol, or umeclidinium-vilanterol) and combination ICS-LABA inhalers (budesonide-formoterol, fluticasone-salmeterol, fluticasone-vilanterol, or mometasone-formoterol). These findings were robust across a range of prespecified subgroup and sensitivity analyses. In this cohort study, LAMA-LABA therapy was associated with improved clinical outcomes compared with ICS-LABA therapy, suggesting that LAMA-LABA therapy should be preferred for patients with COPD."

Clinical • Journal • Asthma • Chronic Obstructive Pulmonary Disease • Immunology • Infectious Disease • Pneumonia • Pulmonary Disease • Respiratory Diseases

Navafenterol for chronic obstructive pulmonary disease therapy. (PubMed, Expert Opin Investig Drugs) - "despite clinical evidence of efficacy for navafenterol is still limited the existing data prompts further clinical evaluation and also consideration of other inhalation approaches such as pressure metered dose inhalers (pMDIs) or nebulization. Other interesting approach would be combination with another bifunctional molecule such as ensifentrine."

Journal • Chronic Obstructive Pulmonary Disease • Cough • Immunology • Pulmonary Disease • Respiratory Diseases

Treatment Patterns, Healthcare Utilization and Clinical Outcomes of Patients with Chronic Obstructive Pulmonary Disease Initiating Single-Inhaler Long-Acting β-Agonist/Long-Acting Muscarinic Antagonist Dual Therapy in Primary Care in England. (PubMed, Int J Chron Obstruct Pulmon Dis) - "Of 10,991 incident users included, 9888 (90.0%) were non-triple therapy users, indexed on umeclidinium/vilanterol (n=4805), aclidinium/formoterol (n=2109), indacaterol/glycopyrronium (n=1785) and tiotropium/olodaterol (n=1189). Patients initiating treatment with single-inhaler LAMA/LABA in primary care in England were unlikely to switch treatments in the first three months following initiation, but some may discontinue respiratory medication. Outcomes were similar across indexed treatments."

Clinical data • HEOR • Journal • Retrospective data • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

SPC Korea, exclusive domestic distribution of two COPD new drugs [Google translation] (Daily Pharm) - "SPC Korea will be in charge of domestic supply of two COPD new drugs....Since the 1st, the company has been contracting with COVIS Pharma GmbH...to treat chronic obstructive pulmonary disease (COPD), 'Eclira (aclidinium bromide)' and 'Duarclear (aclidinium)'. bromide, formoterol)' for domestic exclusive sales and distribution....A company official said, 'With this contract, we will strengthen the company's existing respiratory treatment portfolio and provide new treatment options in Korea through the introduction of excellent global new drugs.'"

Commercial • Chronic Obstructive Pulmonary Disease • Respiratory Diseases

Inhaled Long-acting Bronchodilators With or Without Inhaled Glucocorticosteroids for Preventing Hospitalizations and Death in Elderly Patients With Chronic Obstructive Pulmonary Disease (clinicaltrials.gov) - P4 | N=843 | Terminated | Sponsor: Università degli Studi di Ferrara | Trial completion date: Mar 2023 ➔ Oct 2022 | Recruiting ➔ Terminated; Contract terminated between AIFA and the Sponsor (University of Ferrara)

Trial completion date • Trial termination • Chronic Obstructive Pulmonary Disease • Congestive Heart Failure • Immunology • Pulmonary Disease • Respiratory Diseases

Covis Pharma Announces Positive Topline Results from the AVANT Phase 3 Clinical Trial Showing Significant Improvement in Patients with Moderate to Severe Stable COPD (GlobeNewswire) - P3 | N=1,067 | AVANT (NCT03022097) | Sponsor: AstraZeneca | "Covis Pharma Group ('Covis')...announced positive topline results from the AVANT phase 3 clinical trial for Duaklir® (aclidinium bromide 400µg /formoterol 12µg twice-daily) and Eklira® (aclidinium bromide 400µg twice-daily) – known as Tudorza® in the U.S. This 24-week study achieved statistically significant and clinically important outcomes for all key endpoint measures of efficacy in adult patients with moderate to severe stable chronic obstructive pulmonary disease (COPD)....Detailed results of the study are planned for future publication....A full analysis of the AVANT data is ongoing with complete results to be provided, or submitted with the AVANT NDA, to the China Food and Drug Administration (CFDA)."

P3 data: top line • Chronic Obstructive Pulmonary Disease • Respiratory Diseases

A Real-World Study on the Day and Night-Time Symptoms Among Greek COPD Patients Who Recently Initiated Treatment with Dual Bronchodilation: The DANICO Study. (PubMed, Int J Chron Obstruct Pulmon Dis) - "Satisfaction with using aclidinium/formoterol across patients was high, as well as compliance to therapy. Aclidinium/formoterol provided significant benefits on the quality of life of COPD patients by reducing the morning, daytime and the night-time symptoms and symptom burden in GOLD Groups B-D, and activity impairment under real-life conditions in all GOLD ABCD groups."

Journal • Observational data • Real-world evidence • Chronic Obstructive Pulmonary Disease • CNS Disorders • Immunology • Pulmonary Disease • Respiratory Diseases • Sleep Disorder

Characterization of Patients with Chronic Obstructive Pulmonary Disease Initiating Single-Inhaler Long-Acting Muscarinic Antagonist/Long-Acting β-Agonist Dual Therapy in a Primary Care Setting in England. (PubMed, Int J Chron Obstruct Pulmon Dis) - "Of 10,991 patients initiating LAMA/LABA, 9888 were non-triple users, of whom 21.3% (n=2109) received aclidinium bromide/formoterol, 18.1% (n=1785) received indacaterol/glycopyrronium, 12.0% (n=1189) received tiotropium bromide/olodaterol and 48.6% (n=4805) received umeclidinium/vilanterol. Characteristics of patients newly initiating single-inhaler LAMA/LABA dual therapy were highly consistent across indexed therapies. As half of non-triple users were not receiving respiratory therapy one year prior to LAMA/LABA initiation, there may be an opportunity for early optimization of treatment to relieve clinical burden versus current prescribing patterns in primary care in England."

Journal • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Risk Assessment of Acute Myocardial Infarction and Stroke Associated with Long-Acting Muscarinic Antagonists, Alone or in Combination, versus Long-Acting beta2-Agonists. (PubMed, Int J Chron Obstruct Pulmon Dis) - "Using LABA as reference, adjusted IRRs [95% confidence intervals] were close to 1 for all study drugs for AMI (lowest for aclidinium/formoterol, 0.95 [0.60-1.52], and highest for LAMA/LABA, 1.23 [0.91-1.67]), stroke (lowest for aclidinium/formoterol, 0.64 [0.39-1.06], and highest for tiotropium, 1.02 [0.81-1.27] for tiotropium) and for MACE (lowest for aclidinium, 0.93 [0.75-1.16], and highest for LAMA/LABA, 1.24 [0.97-1.59]). Risks of AMI, stroke, and MACE in current users of aclidinium, aclidinium/formoterol, tiotropium, other LAMA, LAMA/LABA, or LABA/ICS were similar to the risks among current users of LABA."

Journal • Cardiovascular • Chronic Obstructive Pulmonary Disease • Immunology • Myocardial Infarction • Pulmonary Disease • Respiratory Diseases

AVANT: Study to Assess Efficacy and Safety of Aclidinium Bromide and Aclidinium Bromide/Formoterol Fumarate in Stabile COPD Patients (clinicaltrials.gov) - P3 | N=1067 | Completed | Sponsor: AstraZeneca | Active, not recruiting ➔ Completed

Trial completion • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases