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

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

Cost-Effectiveness of Umeclidinium/Vilanterol Versus Indacaterol/Glycopyrronium in Symptomatic patients with COPD in the UK (ERS 2023) - P4 | "In a UK NHS setting, treatment with UMEC/VI was predicted to improve health outcomes and lower costs compared to IND/GLY in patients with symptomatic COPD. Funding: GSK (217635); Cell and molecular biology; Epidemiology; Public health; Pulmonary function testing; Imaging; General respiratory patient care"

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

LABA/LAMA versus LABA/ICS fixed-dose combinations in the prevention of COPD exacerbations: a modeling analysis of literature aggregate data. (PubMed, Eur J Clin Pharmacol) - "This study showed that not all LABA/LAMA FDCs were superior to LABA/ICS FDCs in safety and in preventing moderate or severe exacerbations in patients with stable COPD, providing important quantitative information for COPD-related guidelines."

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

Efficacy of mometasone/indacaterol/glycopyrronium in patients with inadequately controlled asthma with respect to baseline eosinophil count: Post hoc analysis of IRIDIUM study. (PubMed, Respir Med) - P3 | "MF/IND/GLY showed improvement in lung function and reduction in asthma exacerbations over MF/IND and FLU/SAL independent of baseline eosinophil levels, indicating that eosinophil levels did not affect the efficacy of MF/IND/GLY in patients with inadequately controlled asthma."

Journal • Retrospective data • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Real-world comparative effectiveness of three single-inhaler dual bronchodilators for the treatment of chronic obstructive pulmonary disease. (PubMed, Eur Respir J) - "In a real-world setting of COPD treatment, the three dual bronchodilator combinations were similarly effective on the risk of a severe exacerbation of COPD. However, the vilanterol-umeclidinium and indacaterol-glycopyrronium combinations may confer slightly superior effectiveness than olodaterol-tiotropium on the risk of moderate or severe exacerbation. The potential lower mortality with vilanterol-umeclidinium warrants further investigation."

HEOR • Journal • Real-world • Real-world evidence • 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

Ultrasound assessment of diaphragmatic dynamics in patients with chronic obstructive pulmonary disease after treatment with indacaterol/glycopyrronium. (PubMed, Rev Clin Esp (Barc)) - "Diaphragmatic motility improved after 3 months of treatment with indacaterol/glycopyrronium 85/43 mcg every 24 hours in patients with COPD and moderate to very severe ventilatory obstruction. CU may be useful to assess the response to treatment in these patients."

Journal • Chronic Obstructive Pulmonary Disease • 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