- |||||||||| 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.
- |||||||||| frevecitinib (KN-002) / Vectura, Kinaset Therap
Safety and PK of KN-002 in subjects with moderate to severe asthma using ICS/LABA (A1) - May 31, 2024 - Abstract #ERS2024ERS_3519; P1 Inhaled KN-002 was well tolerated by subjects with moderate to severe asthma using ICS/LABA. Outcomes support the Phase 2 development in subjects with uncontrolled asthma using medium to high dose ICS/LABA treatment.
- |||||||||| frevecitinib (KN-002) / Vectura, Kinaset Therap
KN-002 reduces fractional exhaled nitric oxide in moderate to severe asthma (Lehar 3) - May 31, 2024 - Abstract #ERS2024ERS_2671; P1 KN-002 caused clinically relevant FeNO reduction over 10 days independent of baseline FeNO / blood eosinophils. These results support KN-002 development in eosinophilic and non-eosinophilic moderate to severe asthma.
- |||||||||| 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
- |||||||||| KN-002 / Vectura, Kinaset Therap
Enrollment closed, Trial completion date, Trial primary completion date: Single and Multiple Ascending Dose Study of KN-002 (clinicaltrials.gov) - Jan 5, 2024 P1, N=117, Active, not recruiting, These findings were consistent across all populations evaluated. Recruiting --> Active, not recruiting | Trial completion date: May 2023 --> Apr 2024 | Trial primary completion date: Apr 2023 --> Dec 2023
- |||||||||| Seebri Breezhaler (glycopyrronium bromide) / Novartis, Vectura, Sosei, Onbrez (indacaterol) / Novartis
Journal: The effect of lung emptying before the inhalation of aerosol drugs on drug deposition in the respiratory system. (Pubmed Central) - Jul 5, 2023 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. For drugs with negative correlation of lung dose with flow rate (all the studied drugs except the above two) lung emptying caused increased (Foster
- |||||||||| 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, Recruiting --> Completed Unknown status --> Active, not recruiting | Trial completion date: Feb 2022 --> Dec 2022 | Trial primary completion date: Feb 2022 --> Dec 2022
- |||||||||| KN-002 / Vectura, Kinaset Therap
Enrollment change, Trial completion date, Trial primary completion date: Single and Multiple Ascending Dose Study of KN-002 (clinicaltrials.gov) - Sep 1, 2022 P1, N=128, Recruiting, No abstract available N=80 --> 128 | Trial completion date: May 2022 --> May 2023 | Trial primary completion date: Feb 2022 --> Apr 2023
- |||||||||| 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, N=80 --> 128 | Trial completion date: May 2022 --> May 2023 | Trial primary completion date: Feb 2022 --> Apr 2023 Recruiting --> Active, not recruiting | N=1000 --> 425
- |||||||||| Seebri Breezhaler (glycopyrronium bromide) / Novartis, Vectura, Sosei
New P2 trial: Pharmacokinetics, pharmacodynamics, safety and tolerability of glycopyrronium (bromide) in children (6 to less than 12 years) with asthma. Farmacocinética, farmacodinámica, seguridad y tolerabilidad de bromuro de glicopirronio en niños con asma (de 6 a menos de 12 años de edad). (EUDRACT) - Jun 24, 2022 P2, N=42, Ongoing,
- |||||||||| 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
- |||||||||| Flutiform (fluticasone/formoterol) / Kyorin, Mundipharma, Vectura, Sanofi, Breo Ellipta (fluticasone furoate / vilanterol) / GSK, Innoviva
Observational data, Retrospective data, Journal: Treatment persistence and exacerbations in patients with asthma initiating treatment with inhaled corticosteroids and beta-adrenergic agonists: retrospective cohort study. (Pubmed Central) - Apr 28, 2022 Patients undergoing treatment with FP/FORM and FF/VI versus FP/SAL, BDP/FORM and BUD/FORM were associated with greater treatment adherence (persistence, MPR) and lower rates of exacerbations. However, further studies will be needed to strengthen the consistency of the results.
- |||||||||| 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
- |||||||||| Opdivo (nivolumab) / Ono Pharma, BMS, DV281 / Dynavax
Clinical, P1 data, Journal, Combination therapy, PD(L)-1 Biomarker, IO biomarker: A phase 1b open-label, multicenter study of inhaled DV281, a TLR9 agonist, in combination with nivolumab in patients with advanced or metastatic non-small cell lung cancer. (Pubmed Central) - Apr 2, 2022 Pharmacodynamic advantages at doses above 10 mg were unclear. The long duration of disease control in 50% of patients suggests clinically relevant activity in this population of heavily pretreated patients.
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