- |||||||||| Enerzair Breezhaler (glycopyrrolate/indacaterol/mometasone) / Novartis
Journal: Digitally monitored inhaled therapy: A 'Smart' way to manage severe asthma? (Pubmed Central) - Aug 23, 2024 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.
- |||||||||| Breztri Aerosphere (budesonide/formoterol fumarate/glycopyrronium) / AstraZeneca
Single-inhaler triple therapy improves small airway dysfunction in moderate to severe asthma. (PS-10; Poster board no. 8) - May 31, 2024 - Abstract #ERS2024ERS_2156; 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
- |||||||||| Atectura Breezhaler (indacaterol/mometasone furoate) / Novartis, Merck (MSD)
Trial completion: Anti-inflammatory Effects Glycopyrronium (clinicaltrials.gov) - Jan 12, 2023 P3, N=28, Completed, 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. 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, Active, not recruiting --> Completed Unknown status --> Active, not recruiting | Trial completion date: Feb 2022 --> Dec 2022 | Trial primary completion date: Feb 2022 --> Dec 2022
- |||||||||| Enerzair Breezhaler (glycopyrrolate/indacaterol/mometasone) / Novartis
Enrollment closed, Enrollment change, Adherence: ADITION: Digital Adherence Monitoring of Inhalative Therapy in Real- Life Conditions (clinicaltrials.gov) - Aug 11, 2022 P=N/A, N=425, Active, not recruiting, Unknown status --> Active, not recruiting | Trial completion date: Feb 2022 --> Dec 2022 | Trial primary completion date: Feb 2022 --> Dec 2022 Recruiting --> Active, not recruiting | N=1000 --> 425
- |||||||||| Enerzair Breezhaler (glycopyrrolate/indacaterol/mometasone) / Novartis
“Smart” inhalers: is there a role in the management of severe asthma? (TP-11 in thematic poster area) - Jun 22, 2022 - Abstract #ERS2022ERS_2472; Median FeNO and ACQ-6 score at baseline were 54 ppb and 3.08; and at 4 weeks were 38.5 ppb and 1.8 respectively. All patients had better asthma control at median follow up of 6 months.
- |||||||||| Enerzair Breezhaler (glycopyrrolate/indacaterol/mometasone) / Novartis
Enrollment open, Real-world evidence, Real-world: A 24-week rPMS Study in Real-world Setting for Enerzair (clinicaltrials.gov) - Jun 14, 2022 P=N/A, N=600, Recruiting, All patients had better asthma control at median follow up of 6 months. Not yet recruiting --> Recruiting
- |||||||||| Enerzair Breezhaler (glycopyrrolate/indacaterol/mometasone) / Novartis
Journal: Indacaterol/Glycopyrronium/Mometasone fixed dose combination for uncontrolled asthma. (Pubmed Central) - Apr 6, 2022 IND/GLY/MF was superior to both IND/MF and salmeterol/fluticasone (SAL/FLU), a well-established LABA/ICS combination improving lung function in uncontrolled asthma. Moreover, IND/GLY/MF, delivered through the Breezhaler inhaler in a single inhalation, is the first inhaled therapy prescribed alongside a digital companion, a sensor and the Propeller app, allowing for improved treatment adherence, reduced rescue inhaler usage and hospitalizations, increased patient satisfaction and asthma control.
- |||||||||| Enerzair Breezhaler (glycopyrrolate/indacaterol/mometasone) / Novartis
Enrollment change, Trial withdrawal: SENSE: An Observational Prospective Study to Characterize Patients Initiating Enerzair® Breezhaler®, With or Without Sensor, as a Maintenance Treatment for Asthma (clinicaltrials.gov) - Apr 4, 2022 P=N/A, N=0, Withdrawn, Moreover, IND/GLY/MF, delivered through the Breezhaler inhaler in a single inhalation, is the first inhaled therapy prescribed alongside a digital companion, a sensor and the Propeller app, allowing for improved treatment adherence, reduced rescue inhaler usage and hospitalizations, increased patient satisfaction and asthma control. N=160 --> 0 | Not yet recruiting --> Withdrawn
- |||||||||| Enerzair Breezhaler (glycopyrrolate/indacaterol/mometasone) / Novartis
Trial completion date, Trial primary completion date, Adherence: ADITION: Digital Adherence Monitoring of Inhalative Therapy in Real- Life Conditions (clinicaltrials.gov) - Jan 31, 2022 P=N/A, N=1000, Recruiting, The concentrations of MF in the combinations modulate the effects in the target tissue. Trial completion date: Jun 2022 --> Dec 2022 | Trial primary completion date: Jun 2022 --> Dec 2022
- |||||||||| Enerzair Breezhaler (glycopyrrolate/indacaterol/mometasone) / Novartis
Journal: Inhaled indacaterol/glycopyrronium/mometasone furoate fixed-dose combination in moderate-to-severe asthma. (Pubmed Central) - Jan 29, 2022 The recently approved single-inhaler indacaterol/glycopyrronium/mometasone fixed dose combination has demonstrated to significantly reduce exacerbations, improve FEV, symptoms and quality of life compared to ICS/LABA, including, salmeterol/fluticasone combination. Moreover, once-daily dosing may improve adherence.
- |||||||||| Enerzair Breezhaler (glycopyrrolate/indacaterol/mometasone) / Novartis
Enrollment change, Trial completion date, Trial withdrawal, Trial primary completion date: XPERTT: Investigating the Effects of QVM149 on MRI Ventilation Defects (clinicaltrials.gov) - Dec 14, 2021 P3, N=0, Withdrawn, On a population level, the pharmacokinetics of IND and GLY were comparable between patients with asthma and COPD. N=48 --> 0 | Trial completion date: Jul 2021 --> Dec 2022 | Not yet recruiting --> Withdrawn | Trial primary completion date: Jul 2021 --> Jul 2022
- |||||||||| 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
Review, Journal: Indacaterol/Glycopyrronium/Mometasone: A Review in Asthma. (Pubmed Central) - Nov 4, 2021 Indacaterol/glycopyrronium/mometasone was generally well tolerated, and the most common adverse events were respiratory in nature. In conclusion, combination therapy with indacaterol/glycopyrronium/mometasone represents a valuable option for the maintenance treatment of asthma, with the convenience of once-daily administration via a single inhaler.
- |||||||||| 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.
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