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223 Diseases | | 14 Products |
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9 Trials |  |
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- KN-002 / Vectura, Kinaset Therap
Clinically Relevant Reductions in FeNO Reported After 10-day Treatment With KN-002 in Subjects With Mild Asthma (San Diego Convention Center, Area F (Hall A-B2, Ground Level)) - Feb 20, 2024 - Abstract #ATS2024ATS_5590;
P1
Maximal response was observed at a dose (4 mg BID) administered via a single unit-dose capsule. These outcomes supported the further evaluation of a 4 mg BID regimen in subjects with moderate to severe asthma despite use of concomitant ICS/LABA therapy.
- imatinib (AER-901) / Aerami Therap
uniPHied: A Novel Platform Study Design for a Phase 2 Clinical Trial to Assess the Safety and Efficacy of AER-901 in Pulmonary Hypertension Associated With Interstitial Lung Disease and Pulmonary Arterial Hypertension (San Diego Convention Center, Area A (Hall A-B2, Ground Level)) - Feb 20, 2024 - Abstract #ATS2024ATS_3925;
The unique platform design of uniPHied allows for expeditious evaluation of AER-901 in multiple pulmonary hypertension cohorts (PH-ILD and PAH) using smaller patient numbers. Each cohort is individually powered for the primary endpoint, allowing addition of cohorts for expansion to other pulmonary hypertension groups.
- imatinib (AER-901) / Aerami Therap
Functional Respiratory Imaging and Rapid Deposition Analysis Predict Enhanced Lung Deposition of Imatinib With the AER-901 Inhalation System in Pulmonary Hypertension (San Diego Convention Center, Area F (Hall A-B2, Ground Level)) - Feb 20, 2024 - Abstract #ATS2024ATS_1711;
At equivalent nominal doses, FRI/RDA demonstrated enhanced deposition of imatinib throughout all regions of the lung for AER-901 compared with DPI-imatinib, suggesting that the AER-901 Inhalation System is more efficient than a DPI at delivering imatinib. These findings were consistent across all populations evaluated.
- | Enerzair Breezhaler (glycopyrrolate/indacaterol/mometasone) / Novartis
Journal: Digitally monitored inhaled therapy: A 'Smart' way to manage severe asthma? (Pubmed Central) - Feb 7, 2024
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.
- || 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, Sponsor: Kinaset Therapeutics Inc
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. Recruiting --> Active, not recruiting | Trial completion date: May 2023 --> Apr 2024 | Trial primary completion date: Apr 2023 --> Dec 2023
- ||||| Enerzair Breezhaler (glycopyrrolate/indacaterol/mometasone) / Novartis
Trial completion date, Trial initiation date: 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) - Dec 15, 2023
P3, N=304, Not yet recruiting, Sponsor: Novartis Pharmaceuticals
Recruiting --> Active, not recruiting | Trial completion date: May 2023 --> Apr 2024 | Trial primary completion date: Apr 2023 --> Dec 2023 Trial completion date: Jul 2026 --> Aug 2027 | Initiation date: Nov 2023 --> Dec 2024
- imatinib (AER-901) / Aerami Therap
LOW SYSTEMIC EXPOSURE AND MINIMAL ACCUMULATION PREDICTED WITH TWICE-DAILY ADMINISTRATION OF AER-901 (INHALED IMATINIB) AT POTENTIAL THERAPEUTIC DOSES (Convention Center Exhibit Hall) - Aug 4, 2023 - Abstract #CHEST2023CHEST_4146;
- | Enerzair Breezhaler (glycopyrrolate/indacaterol/mometasone) / Novartis
Journal: Triple Therapy with Mometasone/Indacaterol/Glycopyrronium or Doubling the ICS/LABA Dose in GINA Step 4: IRIDIUM Analyses. (Pubmed Central) - Aug 1, 2023
P3
Trial completion date: Jul 2026 --> Aug 2027 | Initiation date: Nov 2023 --> Dec 2024 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.
- | 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
- imatinib (AER-901) / Aerami Therap
Low Systemic Exposure With Targeted Administration of AER-901 (Inhaled Imatinib): Results of a Phase 1 Clinical Trial (Brown 3) - Jun 17, 2023 - Abstract #ERS2023ERS_3068;
For drugs with negative correlation of lung dose with flow rate (all the studied drugs except the above two) lung emptying caused increased (Foster Epidemiology; Cell and molecular biology; Imaging
- | Seebri Breezhaler (glycopyrronium bromide) / Novartis, Vectura, Sosei
Trial completion date, Trial primary completion date: Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Glycopyrronium (Bromide) in Children (6 to Less Than 12 Years) With Asthma (clinicaltrials.gov) - May 22, 2023
P2, N=42, Recruiting, Sponsor: Novartis Pharmaceuticals
Epidemiology; Cell and molecular biology; Imaging Trial completion date: Feb 2024 --> May 2025 | Trial primary completion date: Feb 2024 --> May 2025
- | Enerzair Breezhaler (glycopyrrolate/indacaterol/mometasone) / Novartis
Retrospective data, Journal: 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 Central) - Apr 25, 2023
Trial completion date: Feb 2024 --> May 2025 | Trial primary completion date: Feb 2024 --> May 2025 Once-daily fixed-dose MF/IND/GLY was efficacious in asthma patients with and without persistent airflow limitation.
- || Flutiform (fluticasone/formoterol) / Kyorin, Mundipharma, Vectura, Sanofi
PK/PD data, Journal: Pharmacokinetic and Pharmacodynamic Comparison of Fluticasone Propionate/Formoterol Fumarate Administered via a Pressurized Metered-Dose Inhaler and a Novel Breath-Actuated Inhaler in Healthy Volunteers. (Pubmed Central) - Apr 17, 2023
Sponsor: Mundipharma Research Ltd. EudraCT 2012-003728-19 (Study 1) and 2013-000045-39 (Study 2).
- imatinib (AER-901) / Aerami Therap
Pharmacokinetic Profile of Imatinib Mesylate Formulation (AER-901) Demonstrates Potential for Therapeutic Exposure Levels at Low Doses After Pulmonary Administration (Walter E. Washington Convention Center, Room 151 B (Street Level)) - Mar 25, 2023 - Abstract #ATS2023ATS_3362;
The pharmacokinetic profile of AER-901 in rats demonstrated nearly 10-fold higher lung exposure compared with the same oral dose, suggesting that in the clinic, lower doses of the inhaled formulation of imatinib may achieve sufficient exposure in the lung. AER-901 is currently being evaluated in a phase 1 clinical study at inhaled doses approximately 5- to 80-fold lower than the oral imatinib doses investigated in the IMPRES trial.
- |||||||||| Enerzair Breezhaler (glycopyrrolate/indacaterol/mometasone) / Novartis
New P3 trial: 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) - Mar 20, 2023
P3, N=304, Not yet recruiting, Sponsor: Novartis Pharmaceuticals
- | Enerzair Breezhaler (glycopyrrolate/indacaterol/mometasone) / Novartis
Journal: Long-term safety of once-daily indacaterol acetate/glycopyrronium bromide/mometasone furoate high-dose, and indacaterol acetate/mometasone furoate high-dose, in Japanese patients with inadequately controlled asthma: Results from two open-label, 52-week studies. (Pubmed Central) - Mar 2, 2023
Once-daily IND/GLY/MF and IND/MF high-dose were well-tolerated in Japanese patients with inadequately controlled asthma. No unexpected safety findings were observed.
- | Flutiform (fluticasone/formoterol) / Kyorin, Mundipharma, Vectura, Sanofi
Journal: Predictors of success/failure in the control of asthmatic smoking patients under conditions of clinical practice. (Pubmed Central) - Feb 27, 2023
An eosinophil count greater than 300 was the main predictor for achieving control. Fluticasone propionate/formoterol FP/FORM was associated with a greater likelihood of improving ACQ score.
- ||| Enerzair Breezhaler (glycopyrrolate/indacaterol/mometasone) / Novartis
Trial completion, Adherence: ADITION: Digital Adherence Monitoring of Inhalative Therapy in Real- Life Conditions (clinicaltrials.gov) - Feb 8, 2023
P=N/A, N=434, Completed, Sponsor: Novartis Pharmaceuticals
Fluticasone propionate/formoterol FP/FORM was associated with a greater likelihood of improving ACQ score. Active, not recruiting --> Completed
- || Enerzair Breezhaler (glycopyrrolate/indacaterol/mometasone) / Novartis
Review, Journal: 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 Central) - Jan 31, 2023
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.
- || 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
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
- ||| imatinib (AER-901) / Aerami Therap
Trial completion: Safety, Tolerability, & Pharmacokinetics Study of Single & Multiple Inhaled Doses of Imatinib Inhalation Solution (clinicaltrials.gov) - Dec 7, 2022
P1, N=83, Completed, Sponsor: Aerami Therapeutics
Active, not recruiting --> Completed 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
Recruiting --> Completed Unknown status --> Active, not recruiting | Trial completion date: Feb 2022 --> Dec 2022 | Trial primary completion date: Feb 2022 --> Dec 2022
- || Seebri Breezhaler (glycopyrronium bromide) / Novartis, Vectura, Sosei
Enrollment open: Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Glycopyrronium (Bromide) in Children (6 to Less Than 12 Years) With Asthma (clinicaltrials.gov) - Sep 26, 2022
P2, N=36, 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
- | Journal: Comparison table: Some lipid-lowering drugs. (Pubmed Central) - Sep 20, 2022
Not yet recruiting --> Recruiting No abstract available
- || 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, Sponsor: Kinaset Therapeutics Inc
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, Sponsor: Novartis Pharmaceuticals
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
Rhinosporidium seebri .. got the similar slide in my MD exit examination (Twitter) - Aug 6, 2022
- || 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, Sponsor: Novartis Farmacéutica, S.A.
- Enerzair Breezhaler (glycopyrrolate/indacaterol/mometasone) / Novartis
Efficacy of indacaterol/glycopyrronium/mometasone (IND/GLY/MF) vs free combination of salmeterol/fluticasone (SAL/FLU) & tiotropium (TIO) in patients with uncontrolled asthma on prior LABA/ICS high-dose (GINA step 5): Results from ARGON study (TP-10 in thematic poster area) - Jun 22, 2022 - Abstract #ERS2022ERS_3856;
P3
Conclusion In patients uncontrolled on LABA/ICS high-dose, efficacy of single inhaler IND/GLY/MF (high- and medium-dose) o.d. was similar to SAL/FLU high-dose b.i.d. & TIO o.d. via two different inhalers with two different dosing regimens, suggestive of potential clinical benefit of this treatment option over the current standard of care.
- Enerzair Breezhaler (glycopyrrolate/indacaterol/mometasone) / Novartis
Medication adherence and asthma control with once-daily indacaterol/glycopyrronium/mometasone (IND/GLY/MF) Breezhaler digital companion: interim analysis from Japan and Germany (TP-10 in thematic poster area) - Jun 22, 2022 - Abstract #ERS2022ERS_3855;
Conclusions Pts using Breezhaler® digital companion showed good medication adherence (>85% over 3 months) and improved asthma control. Further analysis/study is required to account for observed differences between countries.
- Enerzair Breezhaler (glycopyrrolate/indacaterol/mometasone) / Novartis
Medication adherence and asthma control with once-daily indacaterol/glycopyrronium/mometasone (IND/GLY/MF) Breezhaler digital companion: interim analysis from Europe (TP-10 in thematic poster area) - Jun 22, 2022 - Abstract #ERS2022ERS_3854;
Conclusions Pts using Breezhaler® digital companion showed good medication adherence (≥92% over 6 months) which did not decline over time and improved asthma control. Long-term studies may be required to confirm these findings.
- Enerzair Breezhaler (glycopyrrolate/indacaterol/mometasone) / Novartis
Efficacy of once-daily (o.d.) indacaterol/glycopyrronium/mometasone (IND/GLY/MF) vs free combination of twice-daily salmeterol/fluticasone (SAL/FLU) & o.d. tiotropium with respect to age, age at asthma-onset & BMI at baseline: ARGON subgroup analysis (TP-10 in thematic poster area) - Jun 22, 2022 - Abstract #ERS2022ERS_3852;
P3
Therefore, treatment personalisation in terms of patient preference (e.g., convenience of o.d. vs b.i.d. regimen, single inhaler, device type) would be more appropriate.
- Enerzair Breezhaler (glycopyrrolate/indacaterol/mometasone) / Novartis
Efficacy of once-daily medium- or high-dose mometasone/indacaterol/glycopyrronium (MF/IND/GLY) versus twice-daily high-dose fluticasone/salmeterol (FLU/SAL) to control nocturnal symptoms in patients (pts) with inadequately controlled asthma (TP-10 in thematic poster area) - Jun 22, 2022 - Abstract #ERS2022ERS_3851;
P3
Improvements for other parameters were numerically but not statistically better for either dose of MF/IND/GLY vs high-dose FLU/SAL (Table). Conclusion Both doses of MF/IND/GLY taken once daily (a.m.) improved lung function and controlled symptoms throughout the day and during the night, more effectively than twice daily high-dose FLU/SAL.
- Enerzair Breezhaler (glycopyrrolate/indacaterol/mometasone) / Novartis
Effect of once daily (o.d.) mometasone/indacaterol/glycopyrronium (MF/IND/GLY) vs o.d. MF/IND and twice daily (b.i.d.) fluticasone/salmeterol (FLU/SAL) with respect to age, age at asthma-onset and BMI at baseline: Subgroup analysis from IRIDIUM study (TP-10 in thematic poster area) - Jun 22, 2022 - Abstract #ERS2022ERS_3846;
P3
Physicians looking to personalise treatment decision would be better served looking to pts preference factors (e.g., o.d./b.i.d. regimen, device type, availability of digital companion) than those clinical parameters explored here.
- Enerzair Breezhaler (glycopyrrolate/indacaterol/mometasone) / Novartis
Dose delivery characteristics and lung deposition of indacaterol/glycopyrronium/mometasone furoate (IND/GLY/MF) and IND/MF via Breezhaler device: An Alberta Idealised Throat (AIT) evaluation (TP-11 in thematic poster area) - Jun 22, 2022 - Abstract #ERS2022ERS_2481;
At lower flow rates, a lower deposition in oropharynx balanced with higher inhaler device retention of drug particles was observed and vice versa at higher flow rates, which subsequently lead to consistently high lung delivery of all the drug components across all flow rates investigated (Table). Conclusion Both IND/GLY/MF and IND/MF FDC products demonstrated similar lung deposition and highly consistent doses over the wide range of investigated flow rates, despite differences in the composition of the formulations.
- Enerzair Breezhaler (glycopyrrolate/indacaterol/mometasone) / Novartis
Utility of “smart” inhaler and suppression of fractional exhaled nitric oxide (FeNO): does it make a difference to patient outcomes? (TP-11 in thematic poster area) - Jun 22, 2022 - Abstract #ERS2022ERS_2473;
Utilisation of smart inhalers together with FeNO suppression is feasible objective measure. FeNO suppression in conjunction with good adherence and improved asthma control suggests that objective monitoring may lead to better asthma control.
- 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, Sponsor: Novartis Pharmaceuticals
All patients had better asthma control at median follow up of 6 months. Not yet recruiting --> Recruiting
- || Enerzair Breezhaler (glycopyrrolate/indacaterol/mometasone) / Novartis
Review, Journal: A Review of the Unique Drug Development Strategy of Indacaterol Acetate/Glycopyrronium Bromide/Mometasone Furoate: A First-in-Class, Once-Daily, Single-Inhaler, Fixed-Dose Combination Treatment for Asthma. (Pubmed Central) - May 26, 2022
A Video Abstract by Dr Dominic Brittain, Global Drug Development, Novartis. (MP4 228293 kb).
- | 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, Sponsor: Novartis Pharmaceuticals
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.
- |||||| Enerzair Breezhaler (glycopyrrolate/indacaterol/mometasone) / Novartis
New trial, Real-world evidence, Real-world: A 24-week rPMS Study in Real-world Setting for Enerzair (clinicaltrials.gov) - Mar 9, 2022
P=N/A, N=600, Not yet recruiting, Sponsor: Novartis Pharmaceuticals
- | Enerzair Breezhaler (glycopyrrolate/indacaterol/mometasone) / Novartis
Journal: Indacaterol, glycopyrronium, and mometasone: pharmacological interaction and anti-inflammatory profile in hyperresponsive airways. (Pubmed Central) - Mar 4, 2022
IND/MF and IND/GLY/MF combinations synergistically interact in hyperresponsive medium and small airways and modulate the levels of cytokines, neurokinins, ACh, and intracellular cAMP. The concentrations of MF in the combinations modulate the effects in the target tissue.
- || imatinib (AER-901) / Aerami Therap
Trial completion date, Trial primary completion date: Safety, Tolerability, & Pharmacokinetics Study of Single & Multiple Inhaled Doses of Imatinib Inhalation Solution (clinicaltrials.gov) - Feb 16, 2022
P1, N=78, Recruiting, Sponsor: Aerami Therapeutics
The concentrations of MF in the combinations modulate the effects in the target tissue. Trial completion date: Dec 2021 --> Dec 2022 | Trial primary completion date: Dec 2021 --> Dec 2022
- || 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 (clinicaltrials.gov) - Feb 2, 2022
P2, N=36, Not yet recruiting, Sponsor: Novartis Pharmaceuticals
- || 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, Sponsor: Novartis Pharmaceuticals
Trial completion date: Dec 2021 --> Dec 2022 | Trial primary completion date: Dec 2021 --> Dec 2022 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.
- || fluticasone propionate/salmeterol xinafoate inhalation powder / Generic mfg.
Clinical, Journal, Combination therapy: Clinical Interpretation of Efficacy Outcomes in Pharmacological Studies on Triple Fixed-Dose Combination Therapy for Uncontrolled Asthma: Assessment of IRIDIUM and ARGON Studies. (Pubmed Central) - Jan 21, 2022
Overall, HD-MF/IND/GLY induced greater clinically relevant benefits even when compared to HD-FLU/SAL + TIO. Considering that a balanced triple MF/IND/GLY FDC with MD ICS resulted as effective as HD-MF/IND in preventing moderate or severe exacerbations, thus triple ICS/LABA/LAMA FDCs with MD ICS should be considered for the treatment not only of uncontrolled asthma but also for those patients suffering from less severe forms of disease with airflow limitation as well as a possible as-needed therapeutic option.