Atectura Breezhaler (indacaterol/mometasone furoate) / Novartis, Merck (MSD), Valeo Pharma - LARVOL DELTA

A Study to Evaluate the Efficacy and Safety of QMF149 (Indacaterol Acetate/Mometasone Furoate) Versus Budesonide in Children From 6 to Less Than 12 Years of Age With Asthma (clinicaltrials.gov) - P3 | N=200 | Recruiting | Sponsor: Novartis Pharmaceuticals | Trial completion date: Jun 2026 ➔ Aug 2028 | Trial primary completion date: May 2026 ➔ Feb 2028

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

U-LABA/ICS Effects on Exercise Performance, Indacaterol (clinicaltrials.gov) - P=N/A | N=30 | Recruiting | Sponsor: Morten Hostrup, PhD | Trial completion date: Dec 2025 ➔ Dec 2026 | Trial primary completion date: Sep 2025 ➔ Jul 2026

Trial completion date • Trial primary completion date

Role of Lung Function for Exercise Capacity in Well-trained Individuals (clinicaltrials.gov) - P=N/A | N=60 | Recruiting | Sponsor: Morten Hostrup, PhD | Trial completion date: Dec 2025 ➔ Dec 2026 | Trial primary completion date: Sep 2025 ➔ Jul 2026

Trial completion date • Trial primary completion date • Inflammation • Respiratory Diseases

Masterful ecofriendly maintainable spectrophotometric techniques for considering indacaterol acetate and mometasone furoate: full evaluation and comparison of their greenness, whiteness, and blueness profiles. (PubMed, Anal Methods) - "Ecological aspects of the developed work were evaluated and gave satisfactory results using several evaluation tools [such as NEMI, Eco-Scale (=93), GAPI, AGREE (=76)] for the greenness aspect, RGB (=96.3) for the whiteness aspect, and BAGI (=90) for the blueness aspect. Additionally, an environmental assessment and statistical comparisons were made using Student's t-test and the F-test with the published HPLC method and those methods currently in use."

Journal • Asthma • Immunology • Infectious Disease • Novel Coronavirus Disease • Pulmonary Disease • Respiratory Diseases

Evaluation of Lung- Function and Asthma Control in Patients With Persistent Airflow Limitation on Indacaterol/Mometasone/Glycopyrronium Dry Powder Inhaler: A Sub-group Analysis of a Phase IV Study (ATS 2025) - No abstract available

Clinical • P4 data • Asthma • Immunology • Respiratory Diseases

Prospective, Open-Label, Observational, Multicenter, Single Arm, Post-Marketing Study in Asthmatic Patients for Evaluation of Safety and Effectiveness of Indacaterol/Mometasone DPI (PROMISING-SHIFT). (PubMed, Adv Respir Med) - "Once-daily IND/MF DPI demonstrated a favorable safety profile with marked improvements in lung function, asthma control, and patient satisfaction, making it a promising option for long-term asthma management in Indian patients."

Clinical • Journal • Observational data • P4 data • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Different manipulations for resolving the overlapped spectra of novel anti-asthmatic combination: Green-blue-white triple evaluation tools. (PubMed, Anal Biochem) - "This work represents different spectrophotometric techniques for concurrent quantification of Indacaterol (IND) and Mometasone furoate (MOM); co-formulated inhalation capsules to control asthma symptoms...The applied methods' environmental effect was cheeked using Analytical Greenness Calculator (AGREE), Blue Applicability Grade Index (BAGI), and Red-Green-Blue 12 (RGB12). All the utilized metrics showed reliable scores, approving that the proposed methods were adhered to the sustainability principles."

Journal • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

An open-label single arm prospective study to evaluate improvement in ACQ-5 and minimal clinically important difference in ACQ-5 among asthmatic patients on indacaterol-mometasone DPI (APSR 2024) - "Indacaterol-Mometasone (150–80/160/320 mcg) DPI showed significant improvement in ACQ-5 score throughout the study period in inadequately-controlled asthma patients and was well tolerated."

Clinical • Asthma • Cough • Immunology • Respiratory Diseases

A dual methodology employing ion-pair chromatography and built-in UV spectrophotometry for quantifying recently approved combination of mometasone and indacaterol in a novel combined metered dose inhaler: assessing the greenness, carbon footprint, blueness, and whiteness. (PubMed, BMC Chem) - "The application of novel "blueness" and "whiteness" concepts using BAGI and RGB12 algorithms further confirmed superior sustainability, with scores of 87.5 & 90 for blueness and 88.1 & 89.8 for whiteness. Successfully applied to quantify IND and MOM in combined capsules, this work provides a model for eco-friendly pharmaceutical analysis that maintains high analytical reliability while improving sustainability metrics."

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

A drug utilization study to evaluate the use of Mometasone furoate / Indacaterol acetate DPI (ICS/uLABA) at various chest clinics across India: Results from interim analysis (NAPCON 2023) - No abstract available

A drug utilization study to evaluate the use of Mometasone furoate/Indacaterol acetate DPI (ICS/uLABA) at various chest clinics across India: Results from interim analysis (NAPCON 2023) - No abstract available

Role of Lung Function for Exercise Capacity in Well-trained Individuals (clinicaltrials.gov) - P=N/A | N=60 | Recruiting | Sponsor: Morten Hostrup, PhD

New trial • Inflammation • Respiratory Diseases

U-LABA/ICS Effects on Exercise Performance, Indacaterol (clinicaltrials.gov) - P=N/A | N=30 | Recruiting | Sponsor: Morten Hostrup, PhD

New trial

Design of Experiment-Based Green UPLC-DAD Method for the Simultaneous Determination of Indacaterol, Glycopyrronium and Mometasone in their Combined Dosage Form and Spiked Human Plasma. (PubMed, J Chromatogr Sci) - "Also, it was precise where, the % relative standard deviation for the inter-day precision was ranged from 2.571 to 3.484%, 3.180 to 4.123% and 3.150 to 3.984% and the intra-day precision was ranged from 2.351 to 3.125%, 2.512 to 3.544% and 2.961 to 3.983% for indacaterol, glycopyrronium and mometasone, respectively. The limit of detection and the limit of quantification for indacaterol and mometasone were 0.03 and 0.10 μg mL-1 while for glycopyrronium, they were 0.16 and 0.50 μg mL-1."

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

Plackett-Burman and face-centered composite designs for development and optimization of chromatographic method for the simultaneous determination of glycopyrronium, indacaterol and mometasone in their fixed dose combination inhaler - Green profile assessment. (PubMed, J Pharm Biomed Anal) - "The developed method could be implemented in quality control aspects of the cited drugs. Four green metrics were used to evaluate the new RP-HPLC/UV method's greenness and compare it to other published techniques."

Journal

Once Daily Versus Twice Daily Inhaled Corticosteroids Plus Long Acting Beta2-agonists in Patients With Moderate-to-severe Asthma - a Meta-analysis and Systematic Review (ATS 2023) - "In the last decade, two new controller combinations of inhaled corticosteroids (ICS)/ long-acting β2-adrenoceptor agonists (LABA) administered once daily have been proposed to improve adherence to asthma treatment: fluticasone furoate/vilanterol (FF/VI) and mometasone furoate/indacaterol (MF/IND). Once daily ICS/LABA combinations were associated with a reduction in exacerbations, improvement in lung function, and similar control of asthma symptoms and safety profile compared to twice daily ICS/LABA combinations in adults with moderate-to-severe asthma."

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

A Study to Evaluate the Efficacy and Safety of QMF149 (Indacaterol Acetate/Mometasone Furoate) Versus Budesonide in Children From 6 to Less Than 12 Years of Age With Asthma (clinicaltrials.gov) - P3 | N=210 | Recruiting | Sponsor: Novartis Pharmaceuticals | Not yet recruiting ➔ Recruiting

Enrollment open • 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

Anti-inflammatory Effects Glycopyrronium (clinicaltrials.gov) - P3 | N=28 | Active, not recruiting | Sponsor: University Medical Center Groningen | Unknown status ➔ Active, not recruiting | Trial completion date: Feb 2022 ➔ Dec 2022 | Trial primary completion date: Feb 2022 ➔ Dec 2022

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

A Study to Evaluate the Efficacy and Safety of QMF149 (Indacaterol Acetate/Mometasone Furoate) Versus Budesonide in Children From 6 to Less Than 12 Years of Age With Asthma (clinicaltrials.gov) - P3 | N=210 | Not yet recruiting | Sponsor: Novartis Pharmaceuticals

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

A 24-week Prospective, Open-label, Multicenter, Single-arm rPMS Study in Real-world Setting for Atectura® (clinicaltrials.gov) - P=N/A | N=600 | Recruiting | Sponsor: Novartis Pharmaceuticals | Not yet recruiting ➔ Recruiting

Enrollment open • Real-world evidence • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Study to Compare the Pharmacokinetics of Mometasone Furoate Alone and in Combination With Indacaterol in Patients ≥ 6 to < 12 Years Old With Asthma (clinicaltrials.gov) - P2 | N=32 | Completed | Sponsor: Novartis Pharmaceuticals | Recruiting ➔ Completed

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

VALEO PHARMA OBTAINS PUBLIC REIMBURSEMENT FOR ENERZAIR BREEZHALER AND ATECTURA BREEZHALER IN ONTARIO, MANITOBA AND NEW BRUNSWICK (PRNewswire) - "Valeo Pharma...is proud to announce another major milestone for its two innovative Asthma therapies; Enerzair Breezehaler and Atectura Breezhaler, which have been accepted for reimbursement by the Ontario Drug Benefit program, the Manitoba Pharmacare Program, the New Brunswick Drug plan, and the NIHB and VAC federal programs. The public reimbursments are now in effect with the exception of the Ontario listing which takes effect on February 28th, 2022."

Reimbursement • Asthma • Chronic Obstructive Pulmonary Disease • Respiratory Diseases

A 24-week Prospective, Open-label, Multicenter, Single-arm rPMS Study in Real-world Setting for Atectura® (clinicaltrials.gov) - P=N/A | N=660 | Not yet recruiting | Sponsor: Novartis Pharmaceuticals | Initiation date: Jan 2022 ➔ May 2022

Real-world evidence • Trial initiation date • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases