Enerzair Breezhaler (glycopyrrolate/indacaterol/mometasone) / Novartis, Molex, Nxera Pharma, Valeo Pharma - LARVOL DELTA

A Study to Evaluate the Efficacy and Safety of QVM149 (Indacaterol Acetate / Glycopyrronium Bromide / Mometasone Furoate) Versus Salmeterol Xinafoate/Fluticasone Propionate in Children From 12 Years to Less Than 18 Years of Age With Asthma. (clinicaltrials.gov) - P3 | N=304 | Not yet recruiting | Sponsor: Novartis Pharmaceuticals | Trial completion date: Feb 2029 ➔ Dec 2029 | Trial primary completion date: Mar 2026 ➔ Dec 2028

Trial completion date • Trial primary completion date • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Effectiveness of indacaterol/glycopyrronium/mometasone for refractory asthmatic cough after switching from inhaled corticosteroid/long-acting β2-agonist therapy. (PubMed, J Allergy Clin Immunol Glob) - "In this multicenter, randomized, open-label, parallel-group study, 118 patients were randomized to receive either IND/GLY/MF or high-dose ICS/LABA (fluticasone/vilanterol [FF/VI] or budesonide/formoterol [BUD/FM]) for 8 weeks. Symptoms improved comparably between medium-dose IND/GLY/MF and high-dose ICS/LABA combinations, although no superiority could be demonstrated. Medium-dose IND/GLY/MF may be an alternative to high-dose ICS/LABA."

Journal • Asthma • Cough • Immunology • Pulmonary Disease • Respiratory Diseases

A Novel Metered Dose Inhaler Formulation of Triple-Drug Fixed-Dose Combination of Vilanterol, Glycopyrronium, and Fluticasone Furoate: A Phase III, Randomized, Multicenter Trial to Evaluate the Efficacy and Safety in Indian Patients With Uncontrolled Asthma. (PubMed, Clin Ther) - "Efficacy and safety of VIL-GLY-FF-MDI were found to be similar to those of IND-GLY-MF-DPI in Indian patients with persistent asthma. Clinical Trial Registry India identifier: CTRI/2024/01/061230."

Journal • P3 data • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Efficacy and safety of novel fixed dose combination of vilanterol, glycopyrronium, and fluticasone furoate dry powder inhaler: A phase 3, randomized, non-inferiority trial compared with fixed dose combination of indacaterol, glycopyrronium, and mometasone furoate dry powder inhaler in Indian asthma patients. (PubMed, Respir Med) - "VIL-GLY-FF DPI was found non-inferior to IND-GLY-MF DPI in improving trough FEV1 response. The test FDC was well-tolerated in Indian patients with persistent asthma."

Head-to-Head • Journal • P3 data • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

A cost-effectiveness analysis comparing single-inhaler extrafine beclomethasone/formoterol/glycopyrronium bromide against other SITTs in adult patients with uncontrolled asthma in England. (PubMed, Health Econ Rev) - "BDP/FOR/GLY MS and HS were a dominant treatment alternative compared with FF/UMEC/VI, both MS and HS, and IND/GLY/MF HS in patients with asthma uncontrolled by ICS/LABA."

HEOR • Journal • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Evaluating digital adherence support in asthma: the ADITION non-interventional study. (PubMed, ERJ Open Res) - "This study evaluated asthma control and adherence in patients using mometasone furoate/indacaterol/glycopyrronium (MF/IND/GLY) with a digital support system or using any inhaled corticosteroid/long-acting β2-agonist/long-acting muscarinic antagonist (ICS/LABA/LAMA) combination without support...These results illustrate the challenges in evaluating asthma control and adherence in non-interventional studies. Further studies are required to evaluate the value of digital support systems and how they can be used to optimise inhaler adherence."

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

Single inhaler with beclometasone, formoterol, and glycopyrronium versus triple therapies in adults with uncontrolled asthma: a systematic review and meta-analysis. (PubMed, Sci Rep) - "The objective of this study was to determine the comparative efficacy of extra-fine single-inhaler medium-dose (MD) or high-dose (HD) of beclometasone/formoterol/glycopyrronium bromide (BDP/FOR/GLY) compared to other triple therapies in patients whose asthma remains uncontrolled with MD or HD inhaled corticosteroids and long-acting β2-agonists...Among single-inhaler triple therapies, MD BDP/FOR/GLY significantly reduced the risk of severe exacerbations (RR [95% CrI] compared to MD fluticasone/umeclidinium/vilanterol: 0.65 [0.49, 0.89]), while HD BDP/FOR/GLY demonstrated an improved trend in reducing severe and moderate-to-severe exacerbations versus HD indacaterol acetate/glycopyrronium bromide/mometasone, fluticasone/umeclidinium/vilanterol, and salmeterol/fluticasone + tiotropium. HD BDP/FOR/GLY and HD BDP/FOR + tiotropium did not differ significantly. Compared to relevant single-inhaler triple therapies, MD and HD BDP/FOR/GLY are associated with a significant benefit..."

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

A Study to Evaluate the Efficacy and Safety of QVM149 (Indacaterol Acetate / Glycopyrronium Bromide / Mometasone Furoate) Versus Salmeterol Xinafoate/Fluticasone Propionate in Children From 12 Years to Less Than 18 Years of Age With Asthma. (clinicaltrials.gov) - P3 | N=304 | Not yet recruiting | Sponsor: Novartis Pharmaceuticals | Trial completion date: Aug 2027 ➔ Feb 2029

Trial completion date • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Cost-Utility Analysis of Single-Inhaler Indacaterol Acetate/Glycopyrronium Bromide/Mometasone Furoate for Maintenance Therapy in Patients With Moderate-to-Severe Uncontrolled Asthma in China (ISPOR-EU 2024) - "This study aims to evaluate the cost-effectiveness of IND/GLY/MF compared to salmeterol/fluticasone+tiotropium bromide (SAL/FLU+TIO) and SAL/FLU, respectively, for the treatment of adult patients with uncontrolled moderate-to-severe asthma. The single-inhaler IND/GLY/MF offered better clinical efficacy and was considered cost-effective with increased QALY gain for the maintenance therapy in Chinese patients with moderate-to-severe uncontrolled asthma."

Clinical • HEOR • Asthma • Immunology • Respiratory Diseases

Single-inhaler triple therapy improves small airway dysfunction in moderate to severe asthma. (ERS 2024) - " Subjects included 30 asthma patients who switched from ICS/LABA to SITT (fluticasone furoate/vilanterol/umeclinidium, mometasone/indacaterol/glycopyrronium, and budesonide/formoterol/glycopyrronium), with spirometry and oscillometry performed before and after switching... SITT improved SAD, and higher R5−R20 before SITT predicted responsiveness to SITT in moderate to severe asthma patients. Table. Multivariate logistic regression analyses for predicting responders to SITT Adjusted odds ratio 95% confidence interval P-value ACT 0.242 0.049 to 1.190 0.080 History of smoking 0.173 0.024 to 1.260 0.083 R5−R20(per 0.01 cmH2O/L/s) 1.130 1.010 to 1.260 0.037 Fres 0.526 0.2070 to 1.340 0.178"

Asthma • Immunology • Respiratory Diseases

Real-world characteristics of patients with asthma initiating fluticasone furoate/umeclidinium/vilanterol single-inhaler triple therapy in Japan. (PubMed, Respir Investig) - "Patient characteristics were generally similar between treatment groups; SITT initiators had fewer exacerbations and lower rescue medication use than MITT initiators, represented by the greater proportion of IMT among SITT versus MITT initiators. Physicians may have prescribed triple over dual therapy as IMT in response to an exacerbation."

Journal • Real-world • Real-world evidence • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Digitally monitored inhaled therapy: A 'Smart' way to manage severe asthma? (PubMed, J Asthma) - "In this study, assess the ability of a 'smart' inhaler to record adherence in severe asthma patients and measure the impact of this on asthma control.Consecutive consenting patients meeting criteria for biologics had their existing high-dose ICS/LABA//LAMA combination inhaler/s switched to mometasone/indacaterol/glycopyrronium (114/46/136)...Both groups demonstrated a significant reduction in ACQ6 score at follow-up (2.81 vs 1.92, p < 0.001 and 3.05 vs 2.60, p < 0.001, respectively), but there was no statistically significant difference in improvement between groups. Patients with optimal adherence also demonstrated a significant reduction in median FeNO at follow-up (47ppb vs 40ppb, p = 0.003).In severe asthma patients, 'smart' inhalers may represent an effective management tool to improve adherence and asthma control, therefore avoiding the need for patients to commence biological therapies."

Journal • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

A Study to Evaluate the Efficacy and Safety of QVM149 (Indacaterol Acetate / Glycopyrronium Bromide / Mometasone Furoate) Versus Salmeterol Xinafoate/Fluticasone Propionate in Children From 12 Years to Less Than 18 Years of Age With Asthma. (clinicaltrials.gov) - P3 | N=304 | Not yet recruiting | Sponsor: Novartis Pharmaceuticals | Trial completion date: Jul 2026 ➔ Aug 2027 | Initiation date: Nov 2023 ➔ Dec 2024

Trial completion date • Trial initiation date • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Cost-Effectiveness of Single-Inhaler Extrafine Beclomethasone Dipropionate/Formoterol Fumarate/Glycopyrronium vs Other Open or Single-Inhaler Triple Therapies in Adult Patients with Uncontrolled Asthma in England (ISPOR-EU 2023) - " A Markov state-transition model was developed to evaluate the cost-effectiveness of MS BDP/FOR/GLY vs MS fluticasone/ umeclidinium/ vilanterol (FF/UMEC/VI), and HS BDP/FOR/GLY vs HS indacaterol /glycopyrronium/mometasone (IND/GLY/MF), MS FF/UMEC/VI, and HS FF/UMEC/VI. Previous research demonstrated the cost-effectiveness of MS and HS BDP/FOR/GLY in adults with asthma uncontrolled by ICS/LABA. This study found that extrafine SITT with BDP/FOR/GLY is cost-effective in comparison with other SITTs, while comparisons with HS BDP/FOR/GLY were characterized by uncertainty."

Clinical • Cost effectiveness • HEOR • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Beclometasone/Formoterol/Glycopyrronium Vs. Fixed and Open Combinations of Inhaled Corticosteroids, Long-Acting B2-Agonist, and Long-Acting Muscarinic Antagonist in Adults with Uncontrolled Asthma: A Network Meta-Analysis (ISPOR-EU 2023) - "In the HS network, HS BDP/FOR/GLY significantly reduced severe exacerbations compared to MS ICS/LABA [0.61 (0.48, 0.78)], HS ICS/LABA [0.81 (0.66, 0.99)], MS IND/GLY/MF [0.72 (0.55, 0.94)], and MS FF/UMEC/VI [0.54 (0.41, 0.73)], and resulted in numerical improvements compared with HS IND/GLY/MF, salmeterol/ fluticasone + tiotropium (SALM/FF+TIO), and HS FF/UMEC/VI. Compared to relevant SITTs and open triple therapies, MS and HS BDP/FOR/GLY are associated with a statistically significant clinical benefit or numerical differences in the rate of severe and moderate-severe asthma exacerbations."

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

Triple Therapy with Mometasone/Indacaterol/Glycopyrronium or Doubling the ICS/LABA Dose in GINA Step 4: IRIDIUM Analyses. (PubMed, Pulm Ther) - P3 | "Medium-dose MF/IND/GLY improved lung function and reduced asthma exacerbations compared to high-dose ICS/LABA and may be an undervalued option in patients at GINA 2022 step 4."

Journal • Asthma • Immunology • 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

Medication Adherence and Asthma Control with Once-Daily Indacaterol/Glycopyrronium/Mometasone Furoate Breezhaler Digital Companion: 90-Day Analysis from Germany. (PubMed, Pulm Ther) - "The use of IND/GLY/MF (Breezhaler) with a digital companion (sensor + application) may be associated with improved symptom control and high level of controller medication adherence in patients with asthma."

Adherence • Journal • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Real-life effectiveness of indacaterol/glycopyrronium/mometasone for symptomatic relief of cough after switching from inhaled corticosteroid/long-acting β-agonist therapy in patients with asthma: REACH study design. (PubMed, ERJ Open Res) - "Patients with asthma (age ≥20 to <80 years) with a cough visual analogue scale (VAS) ≥40 mm will be randomised 2:1:1 to receive IND/GLY/MF medium-dose 150/50/80 μg once daily or step-up to a high-dose regimen of fluticasone furoate/vilanterol trifenatate (FF/VI) 200/25 µg once daily or budesonide/formoterol fumarate (BUD/FM) 160/4.5 µg four inhalations twice daily during the 8-week treatment period. Cough VAS scores, fractional exhaled nitric oxide, spirometry and blood tests, and the Asthma Control Questionnaire-6, Cough and Sputum Assessment Questionnaire, and Japanese version of the Leicester Cough Questionnaire will be evaluated. REACH will provide valuable evidence on whether a switch to IND/GLY/MF medium-dose or step-up to high-dose ICS/LABA is beneficial for patients with persistent cough despite treatment with medium-dose ICS/LABA."

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

A Study to Evaluate the Efficacy and Safety of QVM149 (Indacaterol Acetate / Glycopyrronium Bromide / Mometasone Furoate) Versus Salmeterol Xinafoate/Fluticasone Propionate in Children From 12 Years to Less Than 18 Years of Age With Asthma (clinicaltrials.gov) - P3 | N=304 | Not yet recruiting | Sponsor: Novartis Pharmaceuticals

New P3 trial • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Efficacy of once-daily, single-inhaler, fixed-dose combination of mometasone/indacaterol/glycopyrronium in patients with asthma with or without persistent airflow limitation: Post hoc analysis from the IRIDIUM study. (PubMed, Respir Med) - "Once-daily fixed-dose MF/IND/GLY was efficacious in asthma patients with and without persistent airflow limitation."

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

ADITION: Digital Adherence Monitoring of Inhalative Therapy in Real- Life Conditions (clinicaltrials.gov) - P=N/A | N=434 | Completed | Sponsor: Novartis Pharmaceuticals | Active, not recruiting ➔ Completed

Adherence • Trial completion • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Mometasone/Indacaterol/Glycopyrronium (MF/IND/GLY) and MF/IND at Different MF Strengths versus Fluticasone Propionate/Salmeterol Xinafoate (FLU/SAL) and FLU/SAL+ Tiotropium in Patients with Asthma. (PubMed, J Asthma Allergy) - "FLU/SAL + o.d. TIO in the ARGON study. These formulations therefore provide novel once-daily treatment options for patients across asthma severity and flexibility for clinicians to step-up or step-down the treatment using the same device and formulations."

Journal • Review • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Anti-inflammatory Effects Glycopyrronium (clinicaltrials.gov) - P3 | N=28 | Completed | Sponsor: University Medical Center Groningen | Active, not recruiting ➔ Completed

Trial completion • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Handok to market Novartis’ respiratory drugs in Korea (Korea Biomedical Review) - "Handok and Novartis Korea signed a 2023 sales contract for three additional types of the latter's respiratory treatments in Korea...and with this contract, it will be in charge of distribution, sales, and promotion for three additional products, including Xoterna, Enerzair, and Atectura, from Jan. 1, 2023. Onbrez and Xoterna are treatments used for chronic obstructive pulmonary disease (COPD)."

Commercial • Asthma • Chronic Obstructive Pulmonary Disease • Respiratory Diseases