Ultibro (glycopyrronium/indacaterol) / Nxera Pharma, Novartis, Azurity Pharma - LARVOL DELTA

Chronic Bronchopulmonary Aspergillosis in COPD—Do We Still Need ICS? A Clinical Case with a Big Question (APSR 2025) - "Case Report : A 70-year-old man (GOLD Group E COPD, hypertension, type-2 diabetes) receiving indacaterol/glycopyrronium presented with his sixth “presumed AECOPD” in 12 months after seven days of dyspnea, severe hoarseness, 39°C fever and copious, thick, green sputum...Empirical broad- spectrum antibiotics and intravenous methylprednisolone failed to improve symptoms (WBC 17.7×10 3 μL −1 ; CRP 83.5 mg L −1 )...Timely antifungal therapy enabled withdrawal of unnecessary corticosteroids and antibiotics, breaking the “exacerbation–steroid–antibiotic” cycle and markedly improving clinical stability. An individualised risk–benefit assessment is essential before initiating or continuing ICS in advanced COPD."

Clinical • Cardiovascular • Chronic Obstructive Pulmonary Disease • Diabetes • Hypertension • Immunology • Infectious Disease • Metabolic Disorders • Otorhinolaryngology • Pneumonia • Pulmonary Disease • Respiratory Diseases • Type 2 Diabetes Mellitus

Efficacy, pharmacokinetics, and safety of nebulized HL231 inhalation solution in patients with chronic obstructive pulmonary disease: a randomized trial. (PubMed, J Thorac Dis) - P2 | "HL231 (261 µg/141 µg) is highly comparable to Ultibro® in bronchodilatation, pharmacokinetics, and safety, making it a potential alternative for COPD patients. This study was registered at Chinese Clinical Trials Registration (ChiCTR2300068316) and clinicaltrials.gov (NCT06619210, retrospectively registered)."

Journal • PK/PD data • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

A UNIQUE CASE OF ASTHMA-COPD AND OBSTRUCTIVE SLEEP APNEA OVERLAP SYNDROME ASSOCIATED WITH RESTLESS LEG SYNDROME AND THROMBOCYTOPENIA (CHEST 2025) - "RLS was diagnosed using the International Restless Leg Syndrome Study Group (IRLSSG) criteria.The patient was started on CPAP, ICS budesonide , glycopyrronium bromide plus indacaterol and Pregabalin . CPAP being the mainstay treatment for OSA along with ICS and LABA for overlap syndrome automatically led to improvement in both RLS and thrombocytopenia. The mortality in COPD patients at ICU settings associated with thrombocytopenia is high, hence the importance of early diagnosis becomes crucial. Also, alleviating RLS greatly impacts the severity of dyspnea and overall well being as seen in this patient."

Clinical • Asthma • Chronic Obstructive Pulmonary Disease • Genetic Disorders • Hematological Disorders • Immunology • Infectious Disease • Inflammation • Movement Disorders • Obesity • Obstructive Sleep Apnea • Pulmonary Emphysema • Respiratory Diseases • Restless Legs Syndrome • Sleep Disorder • Thrombocytopenia

Factors Influencing the Dispersibility of Glycopyrronium Bromide and Indacaterol Maleate - Combined In Vitro and In Silico Study. (PubMed, AAPS PharmSciTech) - "These insights highlight the challenge of developing bioequivalent DPI formulations and emphasize the importance of PSD control, mixing energy optimization, and advanced ML modeling in predicting therapeutic equivalence. The study provides a predictive framework to support the development of generic inhalation products, improving regulatory approval pathways and ensuring effective pulmonary drug delivery."

Journal • Preclinical

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

To Study the Safety and Efficacy of Fixed Dose Combination of Indacaterolmaleate 110 µg + Glycopyrrinium 50 µg versus Tiotropium 9 µg + Formoterol 12 µg in Patients with Chronic Obstructive Airway Disease. (PubMed, Ann Afr Med) - "This study indicated that, beyond FEV1, important PROs as well as lung function improved with the use of long-acting IND/GLY combination when compared with TRP/FOR."

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

Offering Digital Adherence Support Improves Clinical Outcomes for High-Risk Chronic Obstructive Pulmonary Disease (COPD) Patients With Poor Adherence to Inhaled Therapy (ATS 2025) - "The intervention included identification of high-risk COPD patients (≥2 moderate/severe exacerbations in last 2 years) using Optimum Patient Care electronic medical record (EMR) driven quality improvement algorithms, a remote COPD review and a digital adherence support package (comprising Ultibro® Breezhaler®, Propeller Health electronic inhaler monitoring device and smartphone app)... Offering a digital intervention to optimise adherence reduced risk of treatment failure by almost 25% and reduced exacerbation rate by over 10% in high-risk patients with COPD. This is the first large, year-long trial demonstrating improved clinical outcomes in a real-world primary care setting."

Adherence • Clinical • Clinical data • Late-breaking abstract • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Real-world Effectiveness of Single-inhaler Long-acting Dual Bronchodilators in Chinese Patients With Chronic Obstructive Pulmonary Disease (ATS 2025) - " This single-country (China), single-center, retrospective, non-interventional, real-world study evaluated the effectiveness of Umeclidinium/Vilanterol (UMEC/VI) 62.5/25 µg and Indacaterol/Glycopyrronium (IND/GLY) 110/50 μg, administered once daily, in improving clinical outcomes in COPD patients compared to baseline. This real-world study demonstrated the effectiveness of single-inhaler dual bronchodilators in improving lung function among COPD patients in a practical clinical setting and highlighted the potential to restore impaired lung function after treatment."

Clinical • Real-world • Real-world effectiveness • Real-world evidence • Bronchiectasis • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Zydus Healthcare gets CDSCO Panel nod to conduct Phase III CT of Glycopyrrolate plus Indacaterol Metered Dose Inhalation (Medical Dialogues) - "The Subject Expert Committee (SEC), functional under the Central Drug Standard Control Organization (CDSCO), has granted approval to Zydus Healthcare for conducting the Phase III clinical trial of Glycopyrrolate IP eq. to Glycopyrronium 25 mcg plus Indacaterol Maleate eq. to Indacaterol 55 mcg metered dose inhalation. This came after Zydus Healthcare presented a bioequivalence (BE) study report as well as justification for a Phase III clinical trial (CT) waiver before the committee....At the recent SEC meeting for Pulmonary, the expert panel reviewed the proposal along with the Phase III CT protocol before the committee."

Approval • Chronic Obstructive Pulmonary Disease

Evaluation of comparative efficacy of Umeclidinium/Vilanterol versus other bronchodilators in the management of chronic obstructive pulmonary disease: a systematic review and meta-analysis of RCTs. (PubMed, BMC Pulm Med) - "This systematic review and meta-analysis concludes that UMEC and VI combinations are an efficacious treatment option for symptomatic COPD patients."

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

Conduct Phase III CT: CDSCO Panel Tells Zydus Healthcare on Glycopyrrolate plus Indacaterol metered dose inhalation (Medical Dialogues) - "Considering the bioequivalence study report presented by Zydus Healthcare, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has recommended the firm conduct the Phase III clinical trial of the fixed dose combination (FDC) pulmonary drug Glycopyrrolatem plus Indacaterol metered dose inhalation. This came after Zydus Healthcare presented a bioequivalence (BE) study report as well as justification for a Phase III clinical trial (CT) waiver before the committee."

New P3 trial • Chronic Obstructive Pulmonary Disease

Unilateral pulmonary hypoplasia presenting as respiratory failure in a 47 year old man with pulmonary tuberculosis (APSR 2024) - "The patient is currently receiving HRZE treatment and Glycopyrronium + Indacaterol inhaler for PTB, bacteriologically confirmed and COPD, respectively...Compensatory contralateral lung hyperinflation was noted and strengthens congenital etiology.2 Previous studies showed obstructive airway pathology, he presented in respiratory failure with respiratory acidosis, and was managed as such with good clinical response.3 Tuberculosis was noted on bronchial washing and treated. Patient was maintained on LABA+LAMA."

Chronic Obstructive Pulmonary Disease • Cough • Immunology • Infectious Disease • Metabolic Disorders • Pneumonia • Pulmonary Disease • Respiratory Diseases • Tuberculosis

A Study to Evaluate the Safety and Efficacy of HL231 Solution for Inhalation in Patients with COPD (clinicaltrials.gov) - P3 | N=474 | Recruiting | Sponsor: Haisco Pharmaceutical Group Co., Ltd.

New P3 trial • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

18 ADMISSIONS WEREN’T ENOUGH! A CASE OF ACOS WITH PERIPHERAL BLOOD EOSINOPHILIA IN A RESTRICTED TREATMENT SETTING (MTS 2024) - "Despite comprehensive treatment with Ultibro Breezehaler and Fluticasone, his symptoms remained uncontrolled. This case report underscores the challenges involved in diagnosing and managing ACOS, particularly in the context of a patient with a history of COPD and persistent peripheral blood eosinophilia which emphasises the need for heightened clinical awareness and a deep understanding of ACOS to provide optimal care for patients with overlapping respiratory disorders."

Clinical • Asthma • Atopic Dermatitis • Chronic Obstructive Pulmonary Disease • Dermatology • Eosinophilia • Immunology • Pulmonary Disease • Pulmonary Emphysema • Respiratory Diseases

Impact of Indacaterol/Glycopyrrolate on Pulmonary Function and St. George's Respiratory Questionnaire Score in Individuals with Stable Chronic Obstructive Pulmonary Disease. (PubMed, Altern Ther Health Med) - "The conventional group received oral carbocisteine tablets, while the combined compound preparation group received indacaterol/glycopyrrolate inhalation powder spray in addition to the conventional treatment. In treatment of stable COPD patients, the combination of indacaterol/glycopyrrolate with carbocisteine tablets enhances pulmonary function, alleviates airway inflammatory reactions, improves clinical efficacy, enhances psychological resilience, and elevates the quality of life compared to carbocisteine tablets alone. These findings underscore the potential therapeutic benefits of the combined compound preparation in managing stable COPD."

Journal • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases • IL6 • TNFA

Highly sensitive liquid chromatography-mass spectrometry method for the quantitative analysis of mometasone furoate in human plasma: Method validation and application to clinical pharmacokinetic studies. (PubMed, Biomed Chromatogr) - "In addition, MF in the presence of indacaterol and glycopyrronium was proven to be stable at -70°C for at least 157 days. The present method was successfully applied to quantify MF in patients receiving MF, indacaterol, and glycopyrronium as a fixed-dose combination."

Journal • PK/PD data • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

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

Cardiovascular Events with the Use of Long-Acting Muscarinic Receptor Antagonists: An Analysis of the FAERS Database 2020-2023. (PubMed, Lung) - "Our study suggests that inhaled LAMAs are not free from cardiac AE risks. This risk may be more evident when the newer LAMAs are used, but it is generally significantly reduced when COPD patients are treated with dual bronchodilators or triple therapy. However, these results do not prove that LAMAs cause CV AEs, as FAERS data alone are not indicative of a drug's safety profile. Given the frequency with which COPD and cardiovascular disease co-exist, a large study in the general population could shed light on this very important issue."

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

A Study to Assess the Efficacy and Safety of HRG2005 Inhalation in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (clinicaltrials.gov) - P2 | N=200 | Recruiting | Sponsor: Jiangsu HengRui Medicine Co., Ltd. | Not yet recruiting ➔ Recruiting

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

Mixing energy as an adjustment tool for aerodynamic behaviour of an inhaled product: in-vitro and in-vivo effects. (PubMed, Int J Pharm) - "This so-called 'rake' approach allows for quantitation of the candidate formulations relative to the reference product Ultibro® Breezhaler® in terms of the key PK parameters...For AUC of Glyco Easyhaler B was bioequivalent to the reference product. Additional measures for adjustment of formulation performance can be foreseen, whose effects can be predicted based on mixing energy theory."

Journal • Preclinical

TECHNOPHOBIA IS NOT THE MOST SIGNIFICANT PATIENT-REPORTED BARRIER TO ACCEPTING A DIGITAL ADHERENCE PACKAGE: AN ANALYSIS OF THE MAGNIFY TRIAL (BTS WM 2023) - "Eligible patients received a phone call from a pharmacist who conducted a remote patient review and invited them to use the digital support package, comprising an Ultibro Breezhaler and adherence support technology (Propeller Health)...The data suggest that technophobia may not be the most important barrier to patients accepting digital adherence support. A quarter of invited patients did not have a smartphone, highlighting the need for future implementation to ensure equitable access to digital support."

Adherence • Clinical • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Comparative Effectiveness of Umeclidinium/Vilanterol versus Indacaterol/Glycopyrronium on Moderate-to-Severe Exacerbations in Patients with Chronic Obstructive Pulmonary Disease in Clinical Practice in England. (PubMed, Int J Chron Obstruct Pulmon Dis) - "UMEC/VI demonstrated non-inferiority to IND/GLY in moderate-to-severe exacerbation reduction at 6, 12 and 18 months. These results support previous findings demonstrating similarity between UMEC/VI and IND/GLY on reduction of moderate-to-severe exacerbations."

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

A Study to Assess the Efficacy and Safety of HRG2005 Inhalation in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (clinicaltrials.gov) - P2 | N=200 | Not yet recruiting | Sponsor: Jiangsu HengRui Medicine Co., Ltd.

New P2 trial • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

And suddenly, I can't walk (EUSEM 2023) - "His treatment included olmesartan, allopurinol, ezetimibe/atorvastatin 10/20, and indacaterol and glycopyrronium, with doubtful compliance.He refers to weakness in the lower extremities that makes it difficult for him to walk until he suddenly stopped walking 4 days ago, falling and remaining on the ground until he was found by a neighbor.The daughter reports that they were unaware of the history because the patient does not want to be accompanied to the consultation nor does he communicate what is diagnosed.Upon arrival at the emergency department, BP 135/72 mmHg, saturation 95%, HR 82 bpm...Wernicke's encephalopathy dx is verified and pregabalin and thiamine are indicated as treatment.Wernicke's encephalopathy is a neurological and eventually psychiatric disease, mainly caused by vitamin B1 (thiamine) deficiency...Its prevalence is six times higher among chronic alcohol drinkers but it can also occur as a consequence of various diseases as well as in cases..."

Cardiovascular • Chronic Obstructive Pulmonary Disease • CNS Disorders • Dyslipidemia • Hypertension • Immunology • Mental Retardation • Metabolic Disorders • Musculoskeletal Pain • Ophthalmology • Pain • Psychiatry • Pulmonary Arterial Hypertension • Pulmonary Disease • Pulmonary Emphysema • Respiratory Diseases • Ventriculomegaly