Asthma Innovative Triple Therapy! Novartis LABA/LAMA/ICS ProductEnerzair Breezhaler III Clinical Efficacy Beats Shulidi!

!--webeditor: "page title" -- July 13, 2020 /PRNewswire/ Novartis has announced that enerzair Breezhaler (QVM149; indacaterol acetate/glyllillaumiumon) has announced that the asthma three-in-one innovative treatment The full results of the IRIDIUM Study (NCT025717777), acetate/Glon Bromero/Glong Bromo-ammonium/Memison; IND/GLY/MF III IRIDIUM Study (NCT0257177777), have been published in The Lancet Respiratory Medicineresults showed a statistically significant improvement in lung function in patients compared to Atectura Breezhaler (QMF149, IND/MF, acetate datero/Memison)key secondary endpoint was the comparison of Enerzair Breezhaler's improved score on the Asthma Control Questionnaire (ACQ-7), although both therapies improved clinically in this area but did not reach the critical secondary endpointin other secondary endpoint analyses, Enerzzair Breezhaler improved lung function, significantly reduced the acute exacerbation rate of moderate and severe asthma compared to a mature LABA/ICS standard (Sametero/profloxate fluoricalones(Advair, Shuriadi, high dose Sal/Flu (50/500?g) 2 times a day)Enerzair Breezhaler is a fixed-dose combination of ACETATE Datero (IND, a LABA), Glong bromide (GLY), a long-acting toxin-alkali receptor antagonist (LAMA), and monitelothine (MF, high-dose ICS) combined with GLY's anti-venom alkylin-alkali action and high-dose anti-inflammatory actionthe drug is administered using a Breezhaler device with a dose confirmation mechanism, which allows daily inhalation with a single inhalerEarlier this month,, Enerzair Breezhaler received EU approval as a maintenance therapy for adult strains of asthma patients who received long-acting beta 2 receptor agonist (LABA) and high-dose inhaled corticosteroids (ICS) combination therapy that did not adequately control the condition and had experienced one or more acute asthma exacerbations in the previous yearalso approved the drug as the first digital partner (sensors and applications) that provide suction confirmation, drug alerts, and access to objective data to better support treatment decisionsnote, Enerzair Breezhaler is the first Daily LABA/LAMA/ICS fixed dose combination product approved in Europe and the first in the EU to be prescribed with a digital partner (propeller Health sensor and app for Breezhaler devices)digital companion, it provides patients with inhalation confirmations, drug alerts, and access to objective treatment data that can be shared with doctors to help them make better treatment decisionscurrently, enerzair Breezhaler (IND/GLY/MF) is currently approved in Japan, Canada and the European Uniononce a day Atectura Breezhaler (IND/MF) has also been approved in the European Union, Japan, and Canada, a LABA/ICS fixed-dose combination used as a maintenance therapy for adults and adolescents with asthma who are older than 12 years of age, receive inhaled corticosteroids (ICS) and inhale short-acting beta receptor agonists (SABA) that do not adequately control the conditionNovartis is committed to bringing Enerzair Breezhaler (IND/GLY/MF) and Atectura Breezhaler (IND/MF) to patients worldwide, both of which are currently under regulatory review in several countries, including Switzerlandas a continuing commitment to the environmental impact of Novartis's asthma reduction portfolio, both products will be administered through the Breezhaler ® device, which does not use HFA/CFCProfessor Huib Kerstjens, head of pulmonary medicine at the University ofGroningen Medical Centre, said: "The IRIDIUM study data show that in patients who were treated with standard care LABA/ICS but still have symptoms, an ind/GLY/MF per day improved lung function and reduced acute exacerbationthese data are encouraging because achieving optimal symptom control for asthma remains challenging; in GINA stages 4 and 5, at least 45 per cent of patients remain out of control, which can lead to reduced quality of life, reduced productivity and increased emergency or hospital medical care"At Novartis, we are working to reimagine respiratory therapy by bringing innovative drugs and digital solutions to patients," said Dominic Brittain, head of Novartis' Global Program at Novartis,the development of inhalation asthma treatment regimens has been relatively rare over the past decade, the potential of IND/GLY/MF as a daily, fixed-dose combination therapy for uncontrolled asthma is very exciting in this critical study"IRIDIUM study is a randomized, double-blind, parallel group, multi-center Phase III study conducted in more than 3,000 asthma patients to compare the efficacy and safety of IND/GLY/MF and IND/MF in the treatment of asthmathe purpose of thestudy was to evaluate 2 different doses of IND/GLY/MF (high dose: 150/50/160?g; medium dose: 150/50/80?g) to compare 2 corresponding doses of IND/MF (high dose: 150/320?g; medium dose: 150/160?g)all patients in the study group who were treated with moderate or high doses of stable LABA/ICS, had asthma symptoms at screening and had one or more acute exacerbations in the previous yearstudy, approximately 3,092 adult asthma patients in men and women were randomly assigned 1:1:1:1 (approximately 618 patients per group) to be treated with the following options: (1) IND/GLY/MF 150/50/80 ?g (once a day) ;(2) IND/GLY/MF 15 0/50/160 sg (once daily) ;(3) IND/MF 150/160 sg (once a day) ;(4) IND/MF 150/320 sg (once a day) ;(5) Sal Flu/50/500?g (twice per day)the main endpoints of thestudy were: after 26 weeks of treatment, high doses of IND/GLY/MF were superior to high doses of IND/MF, medium dose inIND/GLY/MF compared to medium-dose IND/MF in improving fEV1 in asthma patients (the first second of breathing force in 24 hours after administration)key secondary endpoint scored 2 doses of IND/GLY/MF and the corresponding 2 doses of IND/MF at improved asthma control questionnaire (ACQ-7) after 26 weeks of treatmentsecondary endpoints include: reduction of acute exacerbation rate, comparison of 2 doses of IND/GLY/MF with corresponding 2 doses of IND/MF, and 2 doses of IND/GLY/MF with Sal/Flu (50/500?g)results showed that the study reached the main endpoint: at the 26th week of treatment, high and medium doses of IND/GLY/MF showed a statistically significant improvement in the first second compared to the corresponding 2 doses of IND/MF (trough FEV1) (0.065L, p 0.001; 0.076L, p.001)critical secondary endpoint, the 26th week of treatment, and two treatments resulted in a clinical improvement in the ACQ-7 score from the baseline, but did not reach the critical secondary endpointsecondary endpoint analysis showed that, at the 26th week of treatment, two doses of IND/GLY/MF were observed to significantly improve lung function (FEV1) compared to high doses of Sal/Flu (high dose (high dose s.019 L;p?lt;0.001) and medium dose of (0.099 L;p;lt;001) compared to high doses of Sal/Flu)similar FEV1 improvements were seen in all comparisons in week 52, indicating the potential long-term benefits of IND/GLY/MF as a maintenance drug 2 doses of IND/GLY/MF compared to the corresponding dose of IND/MF and high dose Ofal/Flu (p-lt;0.001), an improvement in FEV1 can be observed 5 minutes after the initial administration, indicating rapid IND/GLY/MF action in further secondary endpoint analysis, high doses of IND/GLY/MF significantly reduced the increase in moderate-to-severe (36% ;p-0.001) and severe (42% ;p-lt.001) asthma exacerbation compared to high-dose Sal/Flu compared to high doses of Sal/Flu1, moderate dose sized indocs in/GLY/MF also observed a reduction in moderate-to-severe (19% ;p-0.041) and severe (16% ;p-0.117) asthma exacerbation rates studies, the overall incidence of adverse events (AE) and severe adverse events (SAE) in IND/GLY/MF and IND/MF was generally low and comparable among treatment groups asthma worsens are the most common AE and SAE () !--/ewebeditor: !--webeditor: !-- !--.