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- || Atectura Breezhaler (indacaterol/mometasone furoate) / Novartis, Merck (MSD)
Clinical, Observational data, P4 data, Journal: 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 Central) - Feb 25, 2025
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.
- Atectura Breezhaler (indacaterol/mometasone furoate) / Novartis, Merck (MSD)
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 (TP28) - Feb 24, 2025 - Abstract #ATS2025ATS_1623;
- | Atectura Breezhaler (indacaterol/mometasone furoate) / Novartis, Merck (MSD)
Journal: Different manipulations for resolving the overlapped spectra of novel anti-asthmatic combination: Green-blue-white triple evaluation tools. (Pubmed Central) - Feb 15, 2025
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.
- Atectura Breezhaler (indacaterol/mometasone furoate) / Novartis, Merck (MSD)
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 () - Nov 5, 2024 - Abstract #APSR2024APSR_191;
All the utilized metrics showed reliable scores, approving that the proposed methods were adhered to the sustainability principles. Indacaterol-Mometasone (150
- | Atectura Breezhaler (indacaterol/mometasone furoate) / Novartis, Merck (MSD)
Journal: 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 Central) - Aug 4, 2024
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.
- | vilanterol (GW642444H) / GSK, Atectura Breezhaler (indacaterol/mometasone furoate) / Novartis, Merck (MSD), Veramyst (fluticasone furoate nasal spray) / GSK
New trial: Role of Lung Function for Exercise Capacity in Well-trained Individuals (clinicaltrials.gov) - Oct 10, 2023
P=N/A, N=60, Recruiting, Sponsor: Morten Hostrup, PhD
- | Atectura Breezhaler (indacaterol/mometasone furoate) / Novartis, Merck (MSD)
New trial: U-LABA/ICS Effects on Exercise Performance, Indacaterol (clinicaltrials.gov) - Oct 3, 2023
P=N/A, N=30, Recruiting, Sponsor: Morten Hostrup, PhD
- | Atectura Breezhaler (indacaterol/mometasone furoate) / Novartis, Merck (MSD)
Journal: 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 Central) - Aug 28, 2023
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
- | Atectura Breezhaler (indacaterol/mometasone furoate) / Novartis, Merck (MSD)
Journal: 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 Central) - Aug 28, 2023
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.
- |||||| Atectura Breezhaler (indacaterol/mometasone furoate) / Novartis, Merck (MSD)
Enrollment open: 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) - May 18, 2023
P3, N=210, Recruiting, Sponsor: Novartis Pharmaceuticals
Four green metrics were used to evaluate the new RP-HPLC/UV method's greenness and compare it to other published techniques. Not yet recruiting --> Recruiting
- Atectura Breezhaler (indacaterol/mometasone furoate) / Novartis, Merck (MSD), Breo Ellipta (fluticasone furoate / vilanterol) / GSK, Innoviva
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 (Walter E. Washington Convention Center, Area J, Hall C (Lower Level)) - Mar 25, 2023 - Abstract #ATS2023ATS_7245;
In the last decade, two new controller combinations of inhaled corticosteroids (ICS)/ long-acting ?2-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.
- || Atectura Breezhaler (indacaterol/mometasone furoate) / Novartis, Merck (MSD)
Trial completion: Anti-inflammatory Effects Glycopyrronium (clinicaltrials.gov) - Jan 12, 2023
P3, N=28, Completed, Sponsor: University Medical Center Groningen
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. Active, not recruiting --> Completed
- || Atectura Breezhaler (indacaterol/mometasone furoate) / Novartis, Merck (MSD)
Enrollment closed, Trial completion date, Trial primary completion date: Anti-inflammatory Effects Glycopyrronium (clinicaltrials.gov) - Nov 18, 2022
P3, N=28, Active, not recruiting, Sponsor: University Medical Center Groningen
Active, not recruiting --> Completed Unknown status --> Active, not recruiting | Trial completion date: Feb 2022 --> Dec 2022 | Trial primary completion date: Feb 2022 --> Dec 2022
- |||||||||| Atectura Breezhaler (indacaterol/mometasone furoate) / Novartis, Merck (MSD)
New P3 trial: 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) - Sep 30, 2022
P3, N=210, Not yet recruiting, Sponsor: Novartis Pharmaceuticals
- ||| Atectura Breezhaler (indacaterol/mometasone furoate) / Novartis, Merck (MSD)
Enrollment open, Real-world evidence, Real-world: A 24-week Prospective, Open-label, Multicenter, Single-arm rPMS Study in Real-world Setting for Atectura (clinicaltrials.gov) - Aug 31, 2022
P=N/A, N=600, Recruiting, Sponsor: Novartis Pharmaceuticals
Unknown status --> Active, not recruiting | Trial completion date: Feb 2022 --> Dec 2022 | Trial primary completion date: Feb 2022 --> Dec 2022 Not yet recruiting --> Recruiting
- || Atectura Breezhaler (indacaterol/mometasone furoate) / Novartis, Merck (MSD)
Clinical, Retrospective data, Journal: Once-daily, single-inhaler indacaterol/mometasone versus twice-daily salmeterol/fluticasone in Asian patients with inadequately controlled asthma: Post hoc pooled analysis from PALLADIUM and IRIDIUM studies. (Pubmed Central) - Jul 16, 2022
Once-daily, single-inhaler IND/MF high-dose improved lung function with better asthma control, reduced asthma exacerbations with comparable safety versus twice-daily SAL/FLU high-dose. IND/MF medium-dose showed comparable outcomes to SAL/FLU high-dose at a reduced steroid dose.
- || Atectura Breezhaler (indacaterol/mometasone furoate) / Novartis, Merck (MSD)
Trial completion, Combination therapy: 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) - Apr 13, 2022
P2, N=32, Completed, Sponsor: Novartis Pharmaceuticals
IND/MF medium-dose showed comparable outcomes to SAL/FLU high-dose at a reduced steroid dose. Recruiting --> Completed
- || Atectura Breezhaler (indacaterol/mometasone furoate) / Novartis, Merck (MSD)
Trial initiation date, Real-world evidence, Real-world: A 24-week Prospective, Open-label, Multicenter, Single-arm rPMS Study in Real-world Setting for Atectura (clinicaltrials.gov) - Feb 16, 2022
P=N/A, N=660, Not yet recruiting, Sponsor: Novartis Pharmaceuticals
Recruiting --> Completed Initiation date: Jan 2022 --> May 2022
- |||||| Atectura Breezhaler (indacaterol/mometasone furoate) / Novartis, Merck (MSD)
New trial, Real-world evidence, Real-world: A 24-week Prospective, Open-label, Multicenter, Single-arm rPMS Study in Real-world Setting for Atectura (clinicaltrials.gov) - Jan 31, 2022
P=N/A, N=660, Not yet recruiting, Sponsor: Novartis Pharmaceuticals
- | Atectura Breezhaler (indacaterol/mometasone furoate) / Novartis, Merck (MSD)
Retrospective data, Journal: One time a day mometasone/indacaterol fixed-dose combination versus two times a day fluticasone/salmeterol in patients with inadequately controlled asthma: pooled analysis from PALLADIUM and IRIDIUM studies. (Pubmed Central) - Nov 29, 2021
P3
One time a day, single-inhaler, high-dose MF/IND reduced asthma exacerbations and improved lung function versus two times a day, high-dose FLU/SAL in patients with inadequately controlled asthma. Similarly, improved outcomes were seen with one time a day, medium-dose MF/IND and two times a day, high-dose FLU/SAL, but at a lower ICS dose.
- || Atectura Breezhaler (indacaterol/mometasone furoate) / Novartis, Merck (MSD), Asmanex Twisthaler (mometasone furoate) / Merck (MSD)
PK/PD data, Journal: Pharmacokinetics of mometasone furoate delivered via two dry powder inhalers. (Pubmed Central) - Nov 6, 2021
Similarly, improved outcomes were seen with one time a day, medium-dose MF/IND and two times a day, high-dose FLU/SAL, but at a lower ICS dose. PK characterization in a healthy volunteer PK study and subsequently an asthma study enabled selection of 80 μg (low), 160 μg (medium), and 320 μg (high) delivered via Breezhaler® as MF doses comparable to the 200 μg, 400 μg and 800 μg doses delivered by Twisthaler®, respectively, as part of QMF149 formulation development.
- || Atectura Breezhaler (indacaterol/mometasone furoate) / Novartis, Merck (MSD)
Clinical, Review, Journal: Dose bridging data for mometasone furoate in once-daily fixed-dose inhaled combinations of mometasone furoate/indacaterol and mometasone furoate/ indacaterol/glycopyrronium in patients with asthma. (Pubmed Central) - Nov 6, 2021
Following this stepwise approach, it was determined that mometasone furoate 80 μg o.d. (medium dose strength) and 160 μg o.d. (high dose strength) in mometasone furoate/indacaterol acetate/glycopyrronium bromide formulation provided comparable inhaled corticosteroid efficacy to mometasone furoate 160 μg o.d. (medium dose strength) and 320 μg o.d. (high dose strength) in the mometasone furoate/indacaterol acetate formulation, respectively. These doses were used in the PLATINUM Phase III clinical program that investigated the efficacy and safety of mometasone furoate/indacaterol acetate and mometasone furoate/indacaterol acetate/glycopyrronium bromide combinations in patients with asthma.
- | Enerzair Breezhaler (glycopyrrolate/indacaterol/mometasone) / Novartis, Atectura Breezhaler (indacaterol/mometasone furoate) / Novartis, Merck (MSD)
Journal: Fixed combination of mometasone, indacaterol, glycopyrronium for the treatment of severe asthma : Enerzair® Breezhaler® (Pubmed Central) - Oct 12, 2021
As compared to an ICS/LABA combination Enerzair® improves expiratory flow rates and reduces exacerbation rate. The Breezhaler® device may be coupled to a sensor (Propeller Health) that, through a bluetooth system, allows to control patient adherence and provides recall to the patient to take his aerosol.
- Atectura Breezhaler (indacaterol/mometasone furoate) / Novartis, Merck (MSD)
[VIRTUAL] Mometasone/indacaterol demonstrates similar efficacy in men and women: pooled analyses of PALLADIUM and IRIDIUM studies () - Jul 29, 2021 - Abstract #ERS2021ERS_4432;
P3
Conclusions High-dose MF/IND o.d. showed comparable improvements in lung function vs high-dose FLU/SAL b.i.d. in patients with inadequately controlled asthma, independent of gender.
- Atectura Breezhaler (indacaterol/mometasone furoate) / Novartis, Merck (MSD), Onbrez (indacaterol) / Novartis
[VIRTUAL] Evaluating contributions of mometasone (MF), indacaterol (IND) and glycopyrronium (GLY) to reduction of exacerbations in patients with inadequately controlled asthma: Results from the IRIDIUM study (Channel 2) - Jul 29, 2021 - Abstract #ERS2021ERS_2442;
P3
Pooled MF/IND/GLY showed reduction in moderate/severe (14%), severe (15%) and all exacerbations (17%) vs pooled MF/IND, highlighting potential role of GLY in exacerbation reduction. High-dose MF/IND showed reductions in moderate/severe (25%), severe (27%) and all exacerbations (25%) vs high-dose FLU/SAL, showing benefits of MF and IND Conclusion Data analysis evaluated in context of 36-42% reduction observed with high-dose MF/IND/GLY vs FLU/SAL in IRIDIUM study highlight considerable contributions of GLY, IND and MF to exacerbation reduction
- || Atectura Breezhaler (indacaterol/mometasone furoate) / Novartis, Merck (MSD)
$VPHIF Valeo Pharma Announces Commercial Launch of Enerzair® Breezhaler® and Atectura® Breezhaler® https://t.co/WILBHPI6l7 (Twitter) - Jun 22, 2021
- || Atectura Breezhaler (indacaterol/mometasone furoate) / Novartis, Merck (MSD)
Enrollment open, Combination therapy: 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) - Jun 16, 2021
P2, N=32, Recruiting, Sponsor: Novartis Pharmaceuticals
High-dose MF/IND showed reductions in moderate/severe (25%), severe (27%) and all exacerbations (25%) vs high-dose FLU/SAL, showing benefits of MF and IND Conclusion Data analysis evaluated in context of 36-42% reduction observed with high-dose MF/IND/GLY vs FLU/SAL in IRIDIUM study highlight considerable contributions of GLY, IND and MF to exacerbation reduction Not yet recruiting --> Recruiting
- ||| Atectura Breezhaler (indacaterol/mometasone furoate) / Novartis, Merck (MSD)
Reimbursement: $VPHIF Valeo Pharma Provides Update on Private Payer Reimbursement for Enerzair® Breezhaler® and Atectura® Breezhaler® https://t.co/bmCt0kVRTj (Twitter) - Jun 1, 2021
- Atectura Breezhaler (indacaterol/mometasone furoate) / Novartis, Merck (MSD)
[VIRTUAL] Pharmacokinetics Of Indacaterol/Mometasone Furoate In Healthy Chinese Volunteers: Results From A Randomized, Open-label, Parallel-group Study () - Feb 3, 2021 - Abstract #AAAAI2021AAAAI_958;
The absorption rate and exposure of IND were comparable across IND/MF low-, medium- and high-dose groups. Those of MF increased with increasing MF dose.
- || Enerzair Breezhaler (glycopyrrolate/indacaterol/mometasone) / Novartis, Atectura Breezhaler (indacaterol/mometasone furoate) / Novartis, Merck (MSD)
Clinical, Journal: Letter to the editor: indacaterol/glycopyrronium/mometasone furoate compared with salmeterol/fluticasone propionate in patients with asthma: a randomized controlled cross-over study. (Pubmed Central) - Jan 30, 2021
P2
In conclusion, both doses of IND/GLY/MF provided superior lung function benefits compared with twice-daily, standard-of-care SFC at the highest approved dose. TRIAL REGISTRATION: ClinicalTrials.gov, (Identifier: NCT03063086), EudraCT start date: May 11, 2017; First patient first visit / study initiation date: May 31, 2017.
- | Xolair (omalizumab) / Roche, Novartis, Onbrez (indacaterol) / Novartis
Journal: Drugs for asthma. (Pubmed Central) - Jan 26, 2021
TRIAL REGISTRATION: ClinicalTrials.gov, (Identifier: NCT03063086), EudraCT start date: May 11, 2017; First patient first visit / study initiation date: May 31, 2017. No abstract available
- ||| Atectura Breezhaler (indacaterol/mometasone furoate) / Novartis, Merck (MSD)
Clinical, P3 data, Journal: Once-daily, single-inhaler mometasone-indacaterol-glycopyrronium versus mometasone-indacaterol or twice-daily fluticasone-salmeterol in patients with inadequately controlled asthma (IRIDIUM): a randomised, double-blind, controlled phase 3 study. (Pubmed Central) - Oct 21, 2020
P3
The safety profile was similar across treatment groups. MF-IND-GLY therefore constitutes a good treatment option in these patients.
- ||| Atectura Breezhaler (indacaterol/mometasone furoate) / Novartis, Merck (MSD)
Clinical, P3 data, Journal: Once-daily mometasone plus indacaterol versus mometasone or twice-daily fluticasone plus salmeterol in patients with inadequately controlled asthma (PALLADIUM): a randomised, double-blind, triple-dummy, controlled phase 3 study. (Pubmed Central) - Oct 21, 2020
P3
Once-daily FDC of ICS and LABA (MF-IND) significantly improved lung function over ICS monotherapy (MF) at week 26; high-dose MF-IND was non-inferior to twice-daily combination of ICS and LABA (high-dose FLU-SAL) for improvement in trough FEV. The combination of MF-IND provides a novel once-daily dry powder option for asthma control.
- || Atectura Breezhaler (indacaterol/mometasone furoate) / Novartis, Merck (MSD)
New P2 trial, Combination therapy: 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) - Oct 19, 2020
P2, N=32, Not yet recruiting, Sponsor: Novartis Pharmaceuticals
- Atectura Breezhaler (indacaterol/mometasone furoate) / Novartis, Merck (MSD), Onbrez (indacaterol) / Novartis
[VIRTUAL] Fixed Dose Combination (FDC) of Indacaterol Acetate (IND) and Mometasone Furoate (MF) As a Maintenance Treatment of Asthma in Patients not Adequately Controlled with Inhaled Corticosteroids and Inhaled Short Acting beta2-Agonists- A Budget ... () - Oct 3, 2020 - Abstract #ISPOREU2020ISPOR-EU_1703;
The increase in savings over the 3 year period is mainly due to the increased use of IND/MF. The sensitivity analysis shows that none of the considered parameters modify the main conclusion of the analysis.
- Atectura Breezhaler (indacaterol/mometasone furoate) / Novartis, Merck (MSD), Onbrez (indacaterol) / Novartis
[VIRTUAL] Cost-Utility Analysis of Fixed Dose Combination (FDC) of Indacaterol Acetate (IND) and Mometasone Furoate (MF) As a Maintenance Treatment of Asthma in Patients not Adequately Controlled with Inhaled Corticosteroids and Inhaled Short Acting ... () - Oct 3, 2020 - Abstract #ISPOREU2020ISPOR-EU_1416;
At a threshold of €5,000 per QALY, IND/MF has nearly 100% of probability of being cost-effective compared to all 3 doses of MF. CONCLUSIONS : The results indicate that IND/MF is cost-effective among the considered comparisons in a representative cohort of asthma patients 12 years or older in Italy.
- ||| Atectura Breezhaler (indacaterol/mometasone furoate) / Novartis, Merck (MSD), Onbrez (indacaterol) / Novartis
Clinical, P3 data, Journal: Efficacy and safety of inhaled once-daily low-dose indacaterol acetate/mometasone furoate in patients with inadequately controlled asthma: Phase III randomised QUARTZ study findings. (Pubmed Central) - Sep 9, 2020
CONCLUSIONS : The results indicate that IND/MF is cost-effective among the considered comparisons in a representative cohort of asthma patients 12 years or older in Italy. These results support the use of low-dose IND/MF 150/80 μg o.d. as a potential therapy for adult and adolescent patients with inadequately controlled asthma.
- Enerzair Breezhaler (glycopyrrolate/indacaterol/mometasone) / Novartis, Atectura Breezhaler (indacaterol/mometasone furoate) / Novartis, Merck (MSD)
[VIRTUAL] Efficacy of single inhaler, once-daily indacaterol/glycopyrronium/mometasone furoate in inadequately controlled asthma: a post-hoc Asian population analysis of the IRIDIUM study () - Aug 14, 2020 - Abstract #WAC2020WAC_1038;
These results support the use of low-dose IND/MF 150/80 μg o.d. as a potential therapy for adult and adolescent patients with inadequately controlled asthma. The password to see abstracts was announced to registrants by email.
- Atectura Breezhaler (indacaterol/mometasone furoate) / Novartis, Merck (MSD)
[VIRTUAL] Indacaterol/mometasone furoate combination: synergism in human hyperresponsive airway smooth muscle (Pre-congress content) - Jul 15, 2020 - Abstract #ERS2020ERS_3010;
Conclusion IND/MF combination synergistically relaxed hyperresponsive human ASM in ex vivo models of bronchial asthma. Funding This study was supported by Novartis Pharma AG, Basel, Switzerland.
- Enerzair Breezhaler (glycopyrrolate/indacaterol/mometasone) / Novartis
[VIRTUAL] IND/GLY/MF: synergism in medium and small human hyperresponsive airways (Pre-congress content) - Jul 15, 2020 - Abstract #ERS2020ERS_2158;
Conclusion IND/GLY/MF synergistically relaxed hyperresponsive human isolated medium and small airways in ex vivo models of bronchial asthma. Funding This study was supported by Novartis Pharma AG, Basel, Switzerland.
- Atectura Breezhaler (indacaterol/mometasone furoate) / Novartis, Merck (MSD)
[VIRTUAL] Effect of indacaterol/mometasone on lung function in adolescents versus overall patient population: PALLADIUM study (Pre-congress content) - Jul 15, 2020 - Abstract #ERS2020ERS_919;
P3
Funding This study was supported by Novartis Pharma AG, Basel, Switzerland. A greater improvement in lung function and a rapid onset of action with IND/MF high- and medium-dose o.d. vs respective MF doses was observed in adolescents, and are consistent with the overall patient population.
- Enerzair Breezhaler (glycopyrrolate/indacaterol/mometasone) / Novartis, Atectura Breezhaler (indacaterol/mometasone furoate) / Novartis, Merck (MSD)
[VIRTUAL] Reduction in asthma exacerbations with indacaterol/glycopyrronium/mometasone high-dose versus medium-dose: a post hoc analysis from the IRIDIUM study (Pre-congress content) - Jul 15, 2020 - Abstract #ERS2020ERS_917;
P3
A greater improvement in lung function and a rapid onset of action with IND/MF high- and medium-dose o.d. vs respective MF doses was observed in adolescents, and are consistent with the overall patient population. IND/GLY/MF high-dose o.d. demonstrated clinically relevant reductions in asthma exacerbations compared with the medium-dose o.d., without any meaningful increase in ICS-related AEs after 52 wks of treatment.
- Enerzair Breezhaler (glycopyrrolate/indacaterol/mometasone) / Novartis, Atectura Breezhaler (indacaterol/mometasone furoate) / Novartis, Merck (MSD)
[VIRTUAL] Lower ICS dose effect on symptoms and rescue medication use of indacaterol/glycopyrronium/mometasone (IND/GLY/MF) medium-dose vs salmeterol/fluticasone (Sal/Flu) high-dose plus tiotropium (Tio): ARGON study (Pre-congress content) - Jul 15, 2020 - Abstract #ERS2020ERS_709;
P3
IND/GLY/MF medium-dose o.d. delivered via a single inhaler was comparable in terms of symptom scores and rescue medication use, while resulting in better improvements in day-time symptoms and morning symptoms vs Sal/Flu high-dose b.i.d. + Tio o.d. delivered via two inhalers, at a reduced ICS dose.
- Atectura Breezhaler (indacaterol/mometasone furoate) / Novartis, Merck (MSD), Onbrez (indacaterol) / Novartis
[VIRTUAL] Once-Daily Indacaterol Acetate and Mometasone Furoate Fixed-Dose Combination for Treatment of Inadequately-Controlled Asthma: Long-Term Safety Study in the Japanese Population (ATS 2020 Virtual) - Jul 6, 2020 - Abstract #ATSI2020ATS-I_3865;
P3
CONCLUSIONS : Treatment with once-daily IND/MF high-dose was well-tolerated in Japanese patients with inadequately-controlled asthma with no new or unexpected safety signals observed. Sustained and clinically meaningful improvements in lung function and asthma control were observed throughout the study.
- Enerzair Breezhaler (glycopyrrolate/indacaterol/mometasone) / Novartis, Atectura Breezhaler (indacaterol/mometasone furoate) / Novartis, Merck (MSD)
[VIRTUAL] Non-Inferior Improvement in Asthma Quality of Life and Favorable Benefit in Terms of Lung Function and Asthma Control with Inhaled Combination of Indacaterol/Glycopyrronium/Mometasone Furoate Once-Daily Compared with the "Loose" Combination of Salmeterol/Fluticasone Twice-Daily Plus Tiotropium in Patients with Uncontrolled Asthma: Results of the Phase III ARGON Study (ATS 2020 Virtual) - Jul 6, 2020 - Abstract #ATSI2020ATS-I_3864;
Both IND/GLY/MF q.d. doses showed non-inferiority with respect to improvements in quality of life vs SFC high-dose b.i.d. + Tio q.d. IND/GLY/MF high-dose q.d. showed greater improvements in lung function and asthma control vs SFC high-dose b.i.d.
- Enerzair Breezhaler (glycopyrrolate/indacaterol/mometasone) / Novartis, Atectura Breezhaler (indacaterol/mometasone furoate) / Novartis, Merck (MSD)
[VIRTUAL] Medium-Dose Indacaterol/Glycopyrronium/Mometasone Furoate Fixed-Dose Combination Improves Lung Function Compared with High-Dose Indacaterol/Mometasone Furoate and Salmeterol/Fluticasone and Reduces Exacerbation Rates Versus High-Dose Salmeterol/Fluticasone in Moderate-to-Severe Asthma: The IRIDIUM Study (ATS 2020 Virtual) - Jul 6, 2020 - Abstract #ATSI2020ATS-I_3862;
P3
IND/GLY/MF medium-dose q.d. resulted in a significant improvement of lung function and a reduction in moderate/severe and all exacerbations versus SFC high-dose b.i.d., while reducing the steroid load. IND/GLY/MF medium dose q.d. also improved lung function versus high-dose IND/MF q.d. in patients with uncontrolled asthma.
- Enerzair Breezhaler (glycopyrrolate/indacaterol/mometasone) / Novartis, Atectura Breezhaler (indacaterol/mometasone furoate) / Novartis, Merck (MSD)
[VIRTUAL] Indacaterol/Glycopyrronium/Mometasone Furoate Improves Lung Function and Reduces Exacerbations Versus Long-Acting β 2 -Agonist/Inhaled Corticosteroid Standard-of-Care in Patients with Uncontrolled Asthma: The Phase III IRIDIUM Study (ATS 2020 Virtual) - Jul 6, 2020 - Abstract #ATSI2020ATS-I_3861;
P3
IND/GLY/MF medium dose q.d. also improved lung function versus high-dose IND/MF q.d. in patients with uncontrolled asthma. The combination inhaled therapy of IND/GLY/MF medium-dose and high-dose q.d. significantly improved lung function versus the comparators, demonstrated comparable improvements in asthma control from baseline versus the respective IND/MF q.d. doses and SFC high-dose b.i.d., and reduced asthma exacerbations versus this standard-of-care in patients with uncontrolled asthma.
- Atectura Breezhaler (indacaterol/mometasone furoate) / Novartis, Merck (MSD)
[VIRTUAL] Indacaterol/Mometasone Furoate Fixed-Dose Combination Improves Lung Function and Decreases Exacerbations Compared with Salmeterol/Fluticasone in Patients with Uncontrolled Asthma: Pooled Analyses of PALLADIUM and IRIDIUM Studies (ATS 2020 Virtual) - Jul 6, 2020 - Abstract #ATSI2020ATS-I_3858;
P3
in patients with uncontrolled asthma. IND/MF medium-dose q.d. resulted in comparable improvements in lung function and reductions in exacerbations versus SFC high-dose b.i.d, with a reduced steroid burden.
- glycopyrrolate/indacaterol/mometasone (QVM149) / Novartis, indacaterol/mometasone furoate (QMF149) / Novartis, Merck (MSD)
Medium-Dose Indacaterol/Glycopyrronium/Mometasone Furoate Fixed-Dose Combination Improves Lung Function Compared with High-Dose Indacaterol/Mometasone Furoate and Salmeterol/Fluticasone and Reduces Exacerbation Rates Versus High-Dose Salmeterol/Fluticasone in Moderate-to-Severe Asthma: The IRIDIUM Study (PENNSYLVANIA CONVENTION CENTER, Hall D-E (200 Level), Area C) - Mar 15, 2020 - Abstract #ATS2020ATS_6269;
P3
IND/GLY/MF medium-dose q.d. resulted in a significant improvement of lung function and a reduction in moderate/severe and all exacerbations versus SFC high-dose b.i.d., while reducing the steroid load. IND/GLY/MF medium dose q.d. also improved lung function versus high-dose IND/MF q.d. in patients with uncontrolled asthma.
- indacaterol/mometasone furoate (QMF149) / Novartis, Merck (MSD)
Indacaterol/Mometasone Furoate Fixed-Dose Combination Improves Lung Function and Decreases Exacerbations Compared with Salmeterol/Fluticasone in Patients with Uncontrolled Asthma: Pooled Analyses of PALLADIUM and IRIDIUM Studies (PENNSYLVANIA CONVENTION CENTER, Hall D-E (200 Level), Area C) - Mar 15, 2020 - Abstract #ATS2020ATS_6265;
P3
in patients with uncontrolled asthma. IND/MF medium-dose q.d. resulted in comparable improvements in lung function and reductions in exacerbations versus SFC high-dose b.i.d, with a reduced steroid burden.