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

Late Breaking Abstract - A Randomized, Open-Label, Active-Controlled Phase I Study of Inhaled Dual PDE3/4 Inhibitor TQC3721 Dry Powder Combined with Glycopyrronium Bromide in Patients with COPD (ERS 2026) - "Participants were randomized 1:1:1:1 to receive 1mg TQC3721 (once daily, QD) combined with 50μg glycopyrronium bromide (GLY, QD), 1mg TQC3721 (twice daily, BID) combined with 50μg GLY (QD), 1.5mg TQC3721 (QD) combined with 50μg GLY (QD), or indacaterol/glycopyrronium (IND/GLY, 110μg/50μg, QD) for 2 weeks. Combination of TQC3721 DPI and GLY exhibits comparable bronchodilator effects to the dual bronchodilator IND/GLY, and is well tolerated. These findings support the further development of a fixed-dose combination of TQC3721 DPI and GLY."

Clinical • Late-breaking abstract • P1 data • Chronic Obstructive Pulmonary Disease • Immunology • Respiratory Diseases

Achieving disease stability in COPD: Post-hoc analyses of TRILOGY, TRINITY and TRIBUTE (ERS 2026) - "The comparators were: TRILOGY, BDP/FF; TRINITY, tiotropium monotherapy (TIO) and BDP/FF plus TIO; TRIBUTE, indacaterol/glycopyrronium (IND/GLY)...Conclusion In patients with COPD who are at increased exacerbation risk, disease stability over 12 months is more likely to be achieved with inhaled triple therapy than with mono- or dual therapy. Funding source: Chiesi Australia Pty Ltd."

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

Comparative efficacy of once-daily LAMA/LABA combinations versus tiotropium on constant-work-rate cycle endurance in COPD: a randomized crossover pilot study (COMPETE) (ERS 2026) - "Four treatments were administered in a randomized order (28 days each, 7-day washout): tiotropium/olodaterol, umeclidinium/vilanterol, indacaterol/glycopyrronium, and tiotropium. We demonstrate that head-to-head CWRCE method can be a useful test for assessing the effect of individual medications and their combinations on exercise tolerance. The high interpatient variability highlights the potential for personalized bronchodilator selection based on CPET, justifying further study in larger cohorts."

Clinical • Chronic Obstructive Pulmonary Disease • Immunology • Respiratory Diseases

Efficacy and population PK model of inhaled AERO-007 (indacaterol/glycopyrrolate), a nebulized once daily LABA+LAMA combination therapy for patients with COPD (ERS 2026) - "Inhaled AERO-007 (100/50μg) via nebulization generated a robust bronchodilator response representing a best-in-class LABA+LAMA combination for once daily dosing with lower systemic exposure compared to the same LABA+LAMA combination administered twice daily via DPI inhaler (27.5/15.6ug)."

Clinical • Combination therapy • Chronic Obstructive Pulmonary Disease • Immunology • Respiratory Diseases

Effects of long-acting bronchodilators on fractional exhaled nitric oxide and systemic inflammatory biomarkers in stable COPD (ERS 2026) - " A total of 43 patients with stable COPD were prospectively randomized to receive either glycopyrronium monotherapy or combined glycopyrronium–indacaterol therapy... The observed association between FeNO and BEC suggests that FeNO may represent a useful non-invasive biomarker of eosinophilic inflammation and inflammatory phenotyping in COPD. LABD therapy was associated with reductions in FeNO levels and selected systemic inflammatory markers at 12 weeks, supporting a potential anti-inflammatory effect of LABDs in patients with COPD."

Biomarker • Chronic Obstructive Pulmonary Disease • Immunology • Inflammation • Respiratory Diseases • CRP

Safety analysis of long-acting dual bronchodilator after market approval: a real-world study from FDA Adverse Event Reporting System (FAERS) database. (PubMed, J Thorac Dis) - "This study evaluated post-marketing safety signals for four dual bronchodilators (formoterol/glycopyrronium, indacaterol/glycopyrronium, vilanterol/umeclidinium, and olodaterol/tiotropium). Olodaterol/tiotropium showed signals for ileus, retinal vein occlusion, cataract, and hip fracture, and exhibited the longest latency period among the other three bronchodilators. This pharmacovigilance study identified significant safety signals associated with four bronchodilators, highlighting both common and drug-specific disproportionality signals and thereby providing essential evidence to support drug monitoring in clinical practice."

Adverse events • FDA event • Journal • Real-world evidence • Cardiovascular • Cataract • Chronic Obstructive Pulmonary Disease • Coronary Artery Disease • Immunology • Musculoskeletal Diseases • Myocardial Infarction • Ophthalmology • Orthopedics • Pulmonary Disease • Respiratory Diseases • Retinal Vein Occlusion

Adherence to LAMA/LABA therapies in middle-aged patients with chronic obstructive pulmonary disease: A group-based trajectory analysis. (PubMed, Respir Investig) - "Middle-aged patients with COPD initiating LAMA/LABA therapy exhibited distinct adherence trajectories. Understanding these patterns may help inform more targeted approaches to support adherence and improve patient outcomes."

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

COMPETE: Comparative Efficacy of Once-daily LAMA/LABA Combinations Versus Tiotropium on Constant-work-rate Cycle Endurance in COPD (clinicaltrials.gov) - P=N/A | N=100 | Suspended | Sponsor: Medical University of Bialystok

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

Temporal and Partial Reversal of Airflow Limitation in Patients With COPD Treated With Single-Inhaler Long-Acting Dual Bronchodilators. (PubMed, Clin Respir J) - "This study demonstrated significant and sustained improvements in lung function in this real-world cohort of COPD patients managed with LABA/LAMA monotherapy. A subset of patients achieved a posttreatment FEV1/FVC ratio above 70%, indicating a potentially meaningful change in airflow limitation after LADB therapy."

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

A Study to Evaluate the Safety and Efficacy of HL231 Solution for Inhalation in Patients With COPD (clinicaltrials.gov) - P3 | N=487 | Completed | Sponsor: Haisco Pharmaceutical Group Co., Ltd. | Recruiting ➔ Completed | Trial primary completion date: Oct 2025 ➔ May 2025

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

Phase 2a, Randomized, Double-blind, Placebo-controlled Study of Inhaled Aero-007, a Novel Inhalation Solution Formulation of LABA and LAMA Combination (Indacaterol And Glycopyrrolate) for Nebulization Delivery in COPD (ATS 2026) - No abstract available

Clinical • P2a data • Chronic Obstructive Pulmonary Disease • Immunology • 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=82 | Terminated | Sponsor: Jiangsu HengRui Medicine Co., Ltd. | N=200 ➔ 82 | Trial completion date: Aug 2025 ➔ Feb 2025 | Recruiting ➔ Terminated | Trial primary completion date: Aug 2025 ➔ Feb 2025; Sponsor's R&D strategy adjusted.

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

Disproportionate increase in COPD exacerbation risk for 3 months after discontinuing LAMA or ICS: insights from the FLAME trial. (PubMed, Thorax) - P3 | "Our findings suggest potent LAMA and ICS treatment withdrawal effects on exacerbations, highlighting the importance of treatment adherence and accounting for withdrawal effects in clinical trials."

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

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