A Phase II, Randomized, Double-blind, Single-dose, Placebo-controlled, 3-Period, 3-Treatment, Crossover, Multicenter Study to Compare the Bronchodilatory Effect and Safety of PT007 to Placebo MDI and Open-Label Ventolin® Evohaler in Adult Participants With Asthma

Phase II study, to investigate the therapeutic efficacy and safety of inhaled PT007 (referred to as AS MDI) compared with placebo MDI and open-label Ventolin Evohaler in male and female participants aged 18 to 65 years (inclusive) with asthma.
This study consists of a screening/run-in period, a treatment period, and a follow-up phone call.

Start Date06 Jan 2025

Sponsor / Collaborator

AstraZeneca PLC

CTRI/2024/10/075854 / Not yet recruitingNot ApplicableIIT

Evaluation of comparative efficacy of inhalation of Dugdhika (Euphorbia prostrata w. Ait) versus Salbutamol in the management of Tamaka Shwasa(Bronchial asthma) – A Randomized Controlled Trial. - NIL

Start Date27 Dec 2024

Sponsor / Collaborator-

CTRI/2024/11/076181 / Not yet recruitingNot Applicable

A Prospective, Randomized, Single-dose, Double-blind, Double-dummy, Four-period, Four-treatment Crossover Pivotal Bronchoprovocation Study to Demonstrate the Pharmacodynamic Bioequivalence of Albuterol sulfate HFA Inhalation Aerosol (E.Q. 90 mcg of albuterol Base/Inh) (of Macleods Pharmaceuticals Ltd.) to Albuterol sulfate HFA Inhalation Aerosol (E.Q. 90 mcg of albuterol Base/Inh) (distributed by Teva Pharmaceuticals USA, Inc.) in Adult Patients with Stable Mild Asthma. - NIL

Start Date05 Nov 2024

Sponsor / Collaborator-

100 Clinical Results associated with Salbutamol sulfate

100 Translational Medicine associated with Salbutamol sulfate

100 Patents (Medical) associated with Salbutamol sulfate

11,030

Literatures (Medical) associated with Salbutamol sulfate

01 Jan 2025·JOURNAL OF ETHNOPHARMACOLOGY

Evidence to support cultivated fruiting body of Ophiocordyceps sinensis (Ascomycota)'s role in relaxing airway smooth muscle

Article

ETHNOPHARMACOLOGICAL RELEVANCE:

Ophiocordyceps sinensis (O. sinensis) is a genus of Ascomycete fungus that is endemic to the alpine meadows of the Tibetan Plateau and adjoining Himalayas. It has been used traditionally as a tonic to improve respiratory health in ancient China as well as to promote vitality and longevity. Bioactive components found in O. sinensis such as adenosine, cordycepin, 3-deoxyadenosine, L-arginine and polysaccharides have gained increasing interest in recent years due to their antioxidative and other properties, which include anti-asthmatic, antiviral, immunomodulation and improvement of general health.

AIM OF THE STUDY:

This study's primary aim was to investigate the effect of a cultivated fruiting body of O. sinensis strain (OCS02®) on airways patency and the secondary focus was to investigate its effect on the lifespan of Caenorhabditis elegans.

MATERIALS AND METHODS:

A cultivated strain, OCS02®, was employed and the metabolic profile of its cold-water extract (CWE) was analysed through liquid chromatography-mass spectrometry (LC-MS). Organ bath approach was used to investigate the pharmacological properties of OCS02® CWE when applied on airway tissues obtained from adult male Sprague-Dawley rats. The airway relaxation mechanisms of OCS02® CWE were explored using pharmacological tools, where the key regulators in airway relaxation and constriction were investigated. For the longevity study, age-synchronised, pos-1 RNAi-treated wild-type type Caenorhabditis elegans at the L4 stage were utilised for a lifespan assay.

RESULTS:

Various glycopeptides and amino acids, particularly a high concentration of L-arginine, were identified from the LC-MS analysis. In airway tissues, OCS02® CWE induced a significantly greater concentration-dependent relaxation when compared to salbutamol. The relaxation response was significantly attenuated in the presence of NG-Nitro-L-arginine methyl ester (L-NAME), 1H-[1,2,4]oxadiazolo [4,3-a]quinoxalin-1-one (ODQ) and several K⁺ channel blockers. The longevity effect induced by OCS02® CWE (5 mg/mL and above) was observed in C. elegans by at least 17%.

CONCLUSIONS:

These findings suggest that the airway relaxation mechanisms of OCS02® CWE involved cGMP-dependent and cGMP-independent nitric oxide signalling pathways. This study provides evidence that the cultivated strain of OCS02® exhibits airway relaxation effects which supports the traditional use of its wild O. sinensis in strengthening respiratory health.

31 Dec 2024·EXPERIMENTAL LUNG RESEARCH

Performance of newly developed add-on devices on aerosol delivery in noninvasive ventilated subjects

Article

Author: Madney, Yasmin M. ; Mohammad, Mohammad F. ; Ali, Ahmed M. Abdelhaleem ; Alqarni, Yousef Saeed ; Alsulami, Fahad T. ; Sarhan, Rania M. ; Abdelrahim, Mohamed E. A. ; Rashad, Amal E.

Background: Several techniques had been developed to generate aerosolized medications during noninvasive ventilation (NIV) using variable inhalation methods. This study hypothesized that large spacers were more efficient significantly than small spacers and adapters during NIV. Objective: The main objective of this study was to compare the performance of newly developed spacers with standard T-piece in NIV chronic obstructive pulmonary disease (COPD) subjects. Methods: Sixty COPD subjects requiring NIV were included in this study. A dual-limb circuit was used, and the mode of ventilator was set in spontaneous volume-controlled mode. Dual-limb ventilation circuit, consists of inspiratory-limb and expiratory-limb, is pressure and volume controlled in response to subject expiration providing relatively high resistance to expiratory flow. Two experimental sets were evaluated: the first was introducing two preliminary pressurized metered-dose inhalers (pMDI) puffs before the nebulization of 1 ml of a respirable solution of salbutamol by vibrating mesh nebulizer (VMN) using Minimhal and Combihaler. The second was to only nebulize 1 ml of salbutamol respirable solution by VMN using Combihaler, Minimhal, and standard T-piece. Two urine samples were collected after aerosol delivery: urine sample after 30 min. (USAL0.5) as an indicator of lung deposition and all urine pooled 24 h (USAL24) post-inhalation as an indicator of systemic absorption. The amount of salbutamol extracted from urine samples was assayed by high-performance liquid chromatography. Results: Minimhal + pMDI + VMN delivered a higher percentage of salbutamol 30 min post-inhalation than Minimhal + VMN (p < 0.001). Also, Combihaler + pMDI + VMN delivered a higher percentage of salbutamol 30 min post-inhalation than Combihaler + VMN (p < 0.001). Combihaler + VMN delivered a higher percentage of salbutamol 30 min and 24 h post-inhalation than both Minimhal + VMN and T-piece + VMN (p < 0.001). Standard T-piece delivered the lowest aerosol amount delivered to the lung compared to both spacers (p < 0.05). Conclusions: Introducing two pMDI puffs significantly improved aerosol delivery by both spacers. Combihaler significantly improves aerosol delivery more than Minimhal.

31 Dec 2024·JOURNAL OF MEDICAL ECONOMICS

Cost-effectiveness analysis of budesonide/formoterol SMART therapy versus salmeterol/fluticasone plus as-needed SABA among patients ≥12 years with moderate asthma from the Chinese societal perspective

Article

Author: Zhou, Keruo ; Xuan, Jianwei ; Zuo, Chenyu ; Xie, Xiazhen ; Zhang, Min

OBJECTIVES:

To evaluate the cost-effectiveness of budesonide/formoterol reliever and maintenance therapy compared with salmeterol/fluticasone plus salbutamol as reliever therapy for asthma patients ≥12 years from the societal perspective in China.

METHODS:

A Markov model was developed with three health states (non-exacerbation, exacerbation, and death) with a lifetime horizon. The exacerbation rates were obtained from a prospective cohort study conducted in Chinese asthma patients. Healthcare resources utilization data were estimated based on current clinical asthma management guidelines. Asthma-related mortality, cost input and utility values were derived from public database and literature. Model robustness was assessed with one-way sensitivity and probabilistic sensitivity analyses.

RESULTS:

Compared with salmeterol/fluticasone plus salbutamol, budesonide/formoterol reliever and maintenance therapy led to fewer exacerbation events (13.6 vs. 15.9) and 0.0077 quality-adjusted life years (QALY) gain at an additional cost of ¥196.38 over lifetime. The base case incremental cost-effectiveness ratio (ICER) was ¥25,409.98 per QALY gained. The variables that had most impact on the model output included drug costs and medication adherence. At a willingness-to-pay threshold of ¥257,094/QALY (3 times of gross domestic product per capita in China in 2022), the probability of budesonide/formoterol maintenance and reliever therapy being cost-effective versus salmeterol/fluticasone plus as-needed salbutamol was 83.00%.

CONCLUSION:

From the societal perspective, budesonide/formoterol reliever and maintenance therapy is likely to be a cost-effective option compared with salmeterol/fluticasone plus as-needed salbutamol for Chinese asthma patients ≥12 years.

News (Medical) associated with Salbutamol sulfate

12 Nov 2024

·www.prnewswire.com

Sanofi/Regeneron Pharmaceuticals' DUPIXENT Approval Marks a Significant Shift in Chronic Obstructive Pulmonary Disease Treatment Landscape | DelveInsight

After over a decade without notable progress in treating chronic obstructive pulmonary disease, patients with this ongoing condition now have two new treatment options, with more expected in the future. Regeneron and Sanofi recently revealed that the FDA has expanded the approved uses of their widely successful drug DUPIXENT to include COPD treatment. This marks the drug's sixth approved indication in the US, following its first approval seven years ago for atopic dermatitis. LAS VEGAS, Nov. 12, 2024 /PRNewswire/ -- Chronic obstructive pulmonary disease (COPD) is a progressive lung condition characterized by obstructed airflow, making breathing difficult. It primarily encompasses two main conditions: chronic bronchitis and emphysema, often coexisting. COPD typically develops due to long-term exposure to irritants such as cigarette smoke, air pollution, or occupational dust. As per DelveInsight analysis, the diagnosed prevalent population of COPD in the 7MM was around 44 million in 2023. These cases of COPD in the 7MM are expected to increase at a significant CAGR of 1.4% throughout the study period (2020–2034). As per the estimates, the majority of cases of COPD are in females as compared to males, in the US. But in EU4 and the UK, and Japan the diagnosed cases of males represent the majority of the cases. Overall, in the 7MM, females are predominantly high in number. In 2023, the US had around 3 million, 9 million, 5 million, and 1 million cases of GOLD 1, GOLD 2, GOLD 3, and GOLD 4, respectively based on the severity of airflow limitation. Estimates suggest that airflow limitation was higher in GOLD 2 severity. Various types of medications are used to manage COPD symptoms and complications, including bronchodilators, which help relax the muscles around the airways. This relaxation opens the airways and makes breathing easier. Most bronchodilators are administered via an inhaler. In more severe cases, the inhaler may also contain steroids to reduce inflammation. Some commonly used short-acting and long-acting bronchodilators for COPD management include Albuterol (ProAir HFA, Ventolin HFA, and others), Ipratropium (Atrovent HFA), Levalbuterol (Xopenex), Aclidinium (Tudorza Pressair), Arformoterol (Brovana), and Formoterol (Perforomist). In the LABA category, medications such as Striverdi Respimat, Arcapta/Onbrez, Serevent, and Brovana are included, while the LAMA class features drugs like Spiriva (available as Spiriva HandiHaler and Spiriva Respimat), Tudorza Pressair, Incruse Ellipta, Yupelri, Seebri Neohaler, and Lonhala Magnair. Since the generic version of Brovana was approved in April 2020, its market share has declined. Additionally, Arcapta Neohaler, Seebri Neohaler, and Utibron Neohaler were discontinued in the US in March 2020, which means they no longer contribute to market size. Patients who do not respond to single therapies are often prescribed double or triple therapy. Among the double therapies, the LABA+ICS combination is widely recommended, with drugs such as Symbicort, Breo Ellipta, and Advair. There are also LABA+LAMA combinations, including Anoro Ellipta, Stiolto Respimat, and Bevespi Aerosphere. In July 2020, the US FDA approved AstraZeneca's BREZTRI AEROSPHERE for the maintenance treatment of patients with COPD. Additionally, in October 2020, TRIXEO AEROSPHERE (a combination of formoterol fumarate, glycopyrronium bromide, and budesonide) received marketing authorization in the EU for the maintenance treatment of adult patients with moderate to severe COPD who are not adequately controlled by either a combination of an ICS and LABA or a LABA and LAMA. Currently, two triple combination therapies are available in the US: BREZTRI and TRELEGY ELLIPTA. Learn more about the FDA-approved COPD drugs @ Drugs for COPD Treatment Recently, Sanofi/Regeneron Pharmaceuticals' DUPIXENT added one more jewel to its crown by getting a label expansion nod for COPD from the FDA, EU, and NMPA. DUPIXENT's approval as the first targeted therapy for COPD represents a significant advancement in the treatment landscape for the disease. Unlike conventional treatments, which largely aim to manage symptoms, DUPIXENT specifically targets the IL-4 and IL-13 pathways linked to type 2 inflammation, a key driver in a subset of COPD patients. This precision in targeting allows for a more tailored treatment, especially for patients with elevated eosinophils, who often experience more frequent exacerbations and worse outcomes. The Phase III BOREAS trial demonstrated that patients treated with DUPIXENT experienced a 30% reduction in moderate-to-severe exacerbations over 52 weeks, significant improvements in lung function, and enhanced quality of life. By Week 52, those on DUPIXENT had improved prebronchodilator FEV1 by 160 mL compared to 77 mL in the placebo group. DUPIXENT was also well-tolerated, with a low frequency of adverse events. These results suggest that DUPIXENT could drastically shift COPD management by reducing exacerbations, improving lung function, and offering a safer, targeted therapy for patients with type 2 inflammation. To know more about COPD treatment options, visit @ New Treatment for COPD The chronic obstructive pulmonary disease pipeline possesses potential drugs in mid-stage developments to be launched in the near future. Itepekimab (Sanofi/Regeneron Pharmaceuticals), Benralizumab (AstraZeneca), Tezepelumab (Amgen/AstraZeneca), Mepolizumab (GSK), and others shall further create a positive impact on the market. Discover which therapies are expected to grab major COPD market share @ COPD Market Report Itepekimab is a fully human monoclonal antibody that targets interleukin-33 (IL-33), a protein involved in both type 1 and type 2 inflammation. The drug is administered via subcutaneous injection. Preclinical studies demonstrated that REGN3500 effectively inhibited several markers of both inflammatory types. Regeneron and Sanofi are investigating REGN3500 in diseases related to respiratory and dermatological inflammation. Currently, REGN3500 is in a Phase III clinical trial for COPD and was developed using Regeneron's VelocImmune technology, which produces optimized fully human antibodies. The development is part of a global collaboration between Regeneron and Sanofi. FASENRA (benralizumab) is a humanized recombinant monoclonal antibody of the IgG1k immunoglobulin type that selectively targets the alpha chain of the interleukin 5 receptor (IL-5R) found on eosinophils and basophils. It prevents IL-5 from binding and stops the hetero-oligomerization of the IL-5R's alpha and beta subunits, thereby inhibiting signal transduction. Additionally, it is an afucosylated IgG, which enhances its affinity for the FcγRIIIα receptor on natural killer cells, macrophages, and neutrophils. Approved by the FDA in November 2017 for severe eosinophilic asthma, benralizumab was developed by MedImmune, AstraZeneca's global biologics R&D division. The company is currently conducting Phase III clinical trials for FASENRA as a treatment for COPD. TEZSPIRE (tezepelumab), a pioneering human monoclonal antibody created by Amgen and AstraZeneca, has shown considerable therapeutic potential for various respiratory conditions. Originally intended for treating COPD, TEZSPIRE has yielded encouraging results in decreasing moderate-to-severe exacerbations in patients with high blood eosinophil counts. Recent findings from the Phase IIa COURSE Trial, unveiled at the ATS 2024 conference, underscored TEZSPIRE's effectiveness in minimizing COPD exacerbations among patients with different eosinophil levels. Mepolizumab is currently undergoing Phase III clinical trials for COPD, particularly in patients with frequent exacerbations and elevated eosinophil levels. It is available as an injectable solution and a powder for reconstitution for subcutaneous administration. The IL-5 receptor complex activates several signaling pathways that lead to the release of cytokines, neuromediators, chemokines, and various kinases, which facilitate eosinophil differentiation, proliferation, recruitment, and degranulation. Mepolizumab works by inhibiting the formation of the IL-5 receptor complex, thereby preventing eosinophil activation. This disruption affects normal eosinophil maturation and function, leading to decreased eosinophilic airway inflammation and reduced eosinophil survival. Discover more about drugs for COPD in development @ COPD Clinical Trials The anticipated launch of these emerging therapies for COPD are poised to transform the market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the COPD market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth. DelveInsight estimates that the market size for COPD in the 7MM is expected to grow from USD 16 billion in 2023 with a significant CAGR of 5% by 2034. This growth is mainly driven by the rise in the number of prevalent cases of COPD, ongoing clinical research, and better diagnostic tools that might improve the prognosis of the disease. DelveInsight's latest published market report titled as Chronic Obstructive Pulmonary Disease Market Insight, Epidemiology, and Market Forecast – 2034 will help you to discover which market leader is going to capture the largest market share. The report provides comprehensive insights into the COPD country-specific treatment guidelines, patient pool analysis, and epidemiology forecast to help understand the key opportunities and assess the market's underlying potential. The COPD market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into: Total Diagnosed Prevalent Cases of COPD Subtype-specific Diagnosed Prevalent Cases of COPD Gender-specific Diagnosed Prevalent Cases of COPD Age-specific Diagnosed Prevalent Cases of COPD Diagnosed Prevalent Cases of COPD Based on Severity of Airflow Limitation Diagnosed Prevalent Cases of COPD Based on Symptoms and Exacerbation History The report provides an edge while developing business strategies by understanding trends shaping and driving the 7MM COPD market. Highlights include: 11-year Forecast 7MM Analysis Epidemiology-based Market Forecasting Historical and Forecasted Market Analysis upto 2034 Emerging Drug Market Uptake Peak Sales Analysis Key Cross Competition Analysis Industry Expert's Opinion Access and Reimbursement Download this COPD market report to assess the epidemiology forecasts, understand the patient journeys, know KOLs' opinions about the upcoming treatment paradigms, and determine the factors contributing to the shift in the COPD market. Also, stay abreast of the mitigating factors to improve your market position in the COPD therapeutic space. Related Reports Chronic Obstructive Pulmonary Disease Pipeline Chronic Obstructive Pulmonary Disease Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key COPD companies, including Sanofi, Chiesi Farmaceutici S.p.A., United Therapeutics Corporation, Verona Pharma plc, Immunotek, Yungjin Pharm. Co., Ltd., Pulmotect, Inc., Tetherex Pharmaceutical, CSL Behring, AstraZeneca, Novartis, Genentech, Vertex Pharmaceuticals, EmeraMed, Afimmune, Mereo BioPharma, Synairgen, Adamis Pharmaceuticals, Quercegen Pharmaceuticals LLC, Regend Therapeutics, Meridigen Biotech Co., Ltd., Pulmatrix, Eisai, GlaxoSmithKline, EpiEndo Pharmaceuticals, 3SBio, OmniSpirant, Foresee Pharmaceuticals, Amgen, Organicell Regenerative Medicine, Arrowhead Pharmaceuticals, ProterixBio, RS BioTherapeutics, MitoRx, C4X Discovery, Respiratorius, ARK biosciences, Incannex, GNI Pharma, Celon pharma, Alveolus Bio, Kinaset therapeutics, Landos Biopharma, Parion Sciences, KeyMed Biosciences, Bioneer corporation, AlgiPharma, Palobiofarma, Dimerix Bioscience, Glenmark Pharmaceuticals, among others. Asthma Market Asthma Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key asthma companies including GlaxoSmithKline, 4D Pharma plc, AstraZeneca, Suzhou Connect Biopharmaceuticals, Avillion, Pearl Therapeutics, ARS Pharmaceuticals, Sinomab, Avalo Therapeutics, Kymab, Sanofi, Cumberland Pharmaceuticals, Genentech, Inc. , among others. Asthma Pipeline Asthma Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, including clinical and non-clinical stage products, and the key asthma companies, including Jiangsu Hengrui Medicine, GlaxoSmithKline, Immunotek SL, AB Science, EMS, Avalo Therapeutics, Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd., ARS Pharmaceuticals, Sanofi, Zura Bio Ltd., AstraZeneca, EURRUS Biotech GmbH, T-Balance Therapeutics GmbH, Gossamer Bio, Aldeyra Therapeutics, Inc., Trio Medicines, Janssen Research & Development, Arrowhead Pharmaceuticals, Hoffman-La-Roche, GlaxoSmithKline, Biohaven Pharmaceutical, TAK-Circulator Co., Shanghai Hengrui Pharmaceutical, among others. Acute Respiratory Distress Syndrome Market Acute Respiratory Distress Syndrome Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key ARDS companies, including MediciNova, Edesa Biotech, Light Chain Biosciences, Boehringer Ingelheim, Genentech, Windtree Therapeutics, Biomarck Pharmaceuticals, Athersys, Healios, Direct Biologics, Biohaven Pharmaceutical, Arch Biopartners, APEPTICO Forschung und Entwicklung GmbH, Staidson (Beijing) Biopharmaceuticals, Veru, Mesoblast Limited, Avalo Therapeutics, Pluristem Therapeutics, ILTOO Pharma, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical ResultDrug ApprovalPhase 3Phase 2

08 Oct 2024

·pmlive.com

AstraZeneca/Avillion share positive phase 3 results for asthma rescue treatment Airsupra

AstraZeneca (AZ) and Avillion have shared positive results from a phase 3b trial of their inhaled anti-inflammatory rescue medication in asthma patients aged 12 years and older. Airsupra (albuterol/budesonide) demonstrated a statistically significant and clinically meaningful reduction in the risk of severe exacerbations when used as an as-needed rescue medication compared to albuterol alone, meeting the trial’s primary endpoint. The BATURA study included patients with intermittent or mild persistent asthma, including those receiving a short-acting beta2-agonist (SABA) alone, low-dose inhaled corticosteroid maintenance therapy, or leukotriene receptor antagonist maintenance therapy. Results also showed that the safety and tolerability of Airsupra was consistent with its established profile, and an independent data monitoring committee recommended that the trial should end early due to “overwhelming efficacy” at the pre-planned analysis, the partners said. Affecting up to 262 million people worldwide, asthma is a long-term inflammatory disease that can cause symptoms such as recurrent breathlessness and wheezing, and a tight chest. Patients remain at risk of severe exacerbations regardless of their disease severity, adherence to treatment or level of control, with an estimated 136 million asthma exacerbations occurring globally every year. Those experiencing asthma symptoms often use a SABA, such as albuterol, as a rescue medicine. However, the companies outlined that taking a SABA alone does not address inflammation, leaving patients at risk of severe exacerbations. In January 2023, Airsupra became the first and only anti-inflammatory rescue medication to be approved in the US for the as-needed treatment or prevention of bronchoconstriction and to reduce the risk of exacerbations in people with asthma aged 18 years and older. Sharon Barr, executive vice-president, biopharmaceuticals research and development at AZ, said the latest results for the treatment “add to the body of evidence supporting Airsupra as a first-in-class rescue treatment and its role in reducing the risk of asthma exacerbations in patients regardless of their disease severity, and reducing the need for systemic corticosteroids”. The new data will now be shared with health authorities and will be presented at this year’s American College of Allergy, Asthma and Immunology Annual Scientific Meeting.

Clinical ResultPhase 3Drug Approval

07 Oct 2024

·www.biospace.com

AIRSUPRA® (albuterol/budesonide) demonstrated statistically significant and clinically meaningful reduction in the risk of severe exacerbations in patients with intermittent or mild persistent asthma in BATURA Phase III trial

Independent Data Monitoring Committee recommended trial stop early due to overwhelming efficacy at pre-planned analysis AstraZeneca’s inhaled anti-inflammatory rescue medication AIRSUPRA demonstrated significant benefit compared to albuterol WILMINGTON, Del.--(BUSINESS WIRE)--Positive high-level results from the BATURA Phase IIIb trial showed AstraZeneca’s AIRSUPRA ® (albuterol/budesonide) met the primary endpoint, demonstrating a statistically significant and clinically meaningful reduction in the risk of a severe exacerbation when used as an as-needed rescue medication in response to symptoms compared to as-needed albuterol. 1 The trial included patients with intermittent or mild persistent asthma, including those on short-acting beta2-agonist (SABA) alone, low-dose inhaled corticosteroid (ICS) maintenance therapy, or leukotriene receptor antagonist (LTRA) maintenance therapy. Asthma is a chronic, inflammatory respiratory disease with variable symptoms that affects as many as 262 million people worldwide, 2 including over 25 million in the US. 3 Patients with mild asthma comprise at least 50% of the US asthma population and are at risk of severe exacerbations. 4,5 James Donohue, Emeritus Professor of Pulmonary Medicine, University of North Carolina, and Chair, Independent Data Monitoring Committee, said: “People with asthma are at risk of severe exacerbations regardless of their disease severity or level of control. By focusing on patients with intermittent or mild persistent asthma, the strong BATURA trial results further demonstrate the clinically meaningful benefit of an anti-inflammatory rescue approach to reduce the risk of severe exacerbations by treating both symptoms and inflammation at the same time.” Sharon Barr, Executive Vice-President, BioPharmaceuticals R&D, AstraZeneca, said: “The impressive BATURA trial results add to the body of evidence supporting AIRSUPRA as a first-in-class rescue treatment and its role in reducing the risk of asthma exacerbations in patients regardless of their disease severity, and reducing the need for systemic corticosteroids.” The safety and tolerability of AIRSUPRA in the BATURA trial was consistent with its established pro no new safety concerns were reported. The data will be shared with health authorities and will be presented as a late-breaker oral presentation at the American College of Allergy, Asthma & Immunology (ACAAI) Annual Scientific Meeting on October 26 2024. AIRSUPRA is the first and only anti-inflammatory rescue medication approved in the US for the as-needed treatment or prevention of bronchoconstriction and to reduce the risk of exacerbations in people with asthma aged 18 years and older. 6 The US approval was based on results from the MANDALA and DENALI Phase III trials. 7,8 AIRSUPRA is also being studied in adolescents with asthma (12 to <18 years old) in the ACADIA Phase III trial and in patients in China in the BAIYUN Phase III trial. 9,10 AIRSUPRA is being developed by AstraZeneca and Avillion. APPROVED USE AIRSUPRA combines 2 medicines to be used as needed as a rescue inhaler in people 18 years of age and older to: treat or prevent symptoms of asthma help prevent sudden severe breathing problems (asthma attacks or exacerbations) IMPORTANT SAFETY INFORMATION Do not use AIRSUPRA if you are allergic to albuterol, budesonide, or any of the ingredients in AIRSUPRA Before using AIRSUPRA, tell your healthcare provider about all your medical conditions and about all the medicines you take A dose of AIRSUPRA is 2 inhalations (puffs) as needed. Use AIRSUPRA exactly as your healthcare provider tells you to use it. Do not use AIRSUPRA more than 12 puffs (which equals 6 doses) within a 24-hour period AIRSUPRA is not to be used as a maintenance treatment for asthma. If you are currently taking medicine long-term to maintain control of asthma symptoms, you should continue to take that medicine as directed by your healthcare provider Do not change or stop other inhaled medicines or asthma medicines (oral or inhaled) without first talking to your healthcare provider Call your healthcare provider or get emergency medical care right away if your breathing problems get worse, you need to use AIRSUPRA more often than usual, or AIRSUPRA does not work as well to relieve your asthma AIRSUPRA can cause serious side effects, including: worsening trouble breathing, coughing, and wheezing (paradoxical bronchospasm). If this happens, stop using AIRSUPRA and call your healthcare provider or get emergency medical care right away. This is more likely to happen with your first use of a new canister of medicine heart problems, including faster heart rate and higher blood pressure possible death in people who use too much AIRSUPRA serious allergic reactions . Tell your healthcare provider or get emergency medical care right away if you have a skin rash, redness, or swelling; severe itching; swelling of the face, mouth, or tongue; trouble breathing or swallowing; or chest pain changes in laboratory blood levels . Low levels of potassium (hypokalemia) may cause abnormal heart rhythms weakened immune system and increased chance of getting infections fungal infection in your mouth and throat (thrush). This is a common side effect. Rinse your mouth with water, if available, without swallowing after using AIRSUPRA to help reduce your chance of getting thrush reduced adrenal function (adrenal insufficiency). This can happen when you start taking a medicine containing an inhaled corticosteroid (such as AIRSUPRA) bone thinning or weakness (osteoporosis) eye problems, including glaucoma and cataracts. Your healthcare provider may suggest having regular eye exams while using AIRSUPRA. Discuss any eye problems with your healthcare provider Common side effects include headache, cough, and hoarseness. These are not all the side effects of AIRSUPRA. For more information, ask your healthcare provider or pharmacist Please see full Prescribing Information and Patient Information and discuss with your doctor. You may report side effects related to AstraZeneca products . Notes Asthma Asthma is a chronic, inflammatory respiratory disease with variable symptoms that affects as many as 262 million people worldwide, 2 including over 25 million in the US. 3 Patients with asthma experience recurrent breathlessness and wheezing, which varies over time, and in severity and frequency. 11 These patients are at risk of severe exacerbations regardless of their disease severity, adherence to treatment or level of control. 12,13 There are an estimated 136 million asthma exacerbations globally per year, 14 including more than 10 million in the US; 3 these are physically threatening and emotionally significant for many patients 15 and can be fatal. 2,16 Inflammation is central to both asthma symptoms 12 and exacerbations. 17 Many patients experiencing asthma symptoms use a SABA (e.g. albuterol) as a rescue medicine; 18-20 however, taking a SABA alone does not address inflammation, leaving patients at risk of severe exacerbations, 21 which can result in impaired quality of life, 22 hospitalisation 23 and frequent oral corticosteroid (OCS) use. 23 Treatment of exacerbations with as few as 1-3 short courses of OCS are associated with an increased risk of adverse health conditions including type 2 diabetes, depression/anxiety, renal impairment, cataracts, cardiovascular disease, pneumonia and fracture. 24 International recommendations from the Global Initiative for Asthma no longer recommend SABA alone as the preferred rescue therapy. 11 BATURA BATURA is a Phase IIIb, US, randomised, double-blind, parallel-group, event-driven trial, comparing the efficacy and safety of using inhaled albuterol/budesonide (180mcg/160mcg) as an as-needed rescue medication in response to symptoms compared to as-needed albuterol (180mcg) for up to 12 months. Patients recruited were aged 12 years and over with intermittent or mild persistent asthma and must have been using as-needed SABA alone, or as-needed SABA on a background of either low-dose ICS or LTRA maintenance therapy. 25 The primary efficacy endpoint was the time to first severe asthma exacerbation during the study period. Secondary endpoints included severe exacerbation rate and total systemic corticosteroid use. 25 AIRSUPRA AIRSUPRA (albuterol/budesonide), formerly known as PT027, is a first-in-class SABA/ICS rescue treatment for asthma in the US, to be taken as needed. It is an inhaled, fixed-dose combination rescue medication containing albuterol (also known as salbutamol), a SABA, and budesonide, a corticosteroid, and has been developed in a pressurised metered-dose inhaler (pMDI) using AstraZeneca’s Aerosphere delivery technology. 6 Outside of the US, AIRSUPRA is also approved in the United Arab Emirates, Kuwait, Bahrain, Qatar and Oman. AstraZeneca’s Collaboration with Avillion In March 2018, AstraZeneca and Avillion signed an agreement to advance AIRSUPRA through a global clinical development program for the treatment of asthma. Under the terms of the agreement, Avillion became the trial sponsor responsible for executing and funding the global, multicentre, clinical trial program for AIRSUPRA through NDA filing to a regulatory decision in the US. Following the successful approval of AIRSUPRA , AstraZeneca is commercializing the medicine. AstraZeneca extended its agreement with Avillion in 2022 to undertake the BATURA Phase IIIb trial to further assess the role of AIRSUPRA in reducing the risk of asthma exacerbations. AstraZeneca in Respiratory & Immunology Respiratory & Immunology, part of AstraZeneca BioPharmaceuticals, is a key disease area and growth driver to the Company. AstraZeneca is an established leader in respiratory care with a 50-year heritage and a growing portfolio of medicines in immune-mediated diseases. The Company is committed to addressing the vast unmet needs of these chronic, often debilitating, diseases with a pipeline and portfolio of inhaled medicines, biologics and new modalities aimed at previously unreachable biologic targets. Our ambition is to deliver life-changing medicines that help eliminate COPD as a leading cause of death, eliminate asthma attacks and achieve clinical remission in immune-mediated diseases. AstraZeneca AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines in Oncology, Rare Diseases and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca operates in over 125 countries, and its innovative medicines are used by millions of patients worldwide. For more information, please visit and follow us on social media @AstraZeneca . References Bonini M, Di Paolo M, Bagnasco D, et al. Minimal clinically important difference for asthma endpoints: an expert consensus report. Eur Respir Rev . 2020; 29: 190137. Global Asthma Network. The Global Asthma Report 2022. [Online]. Available at: . Accessed September 2024. CDC. Most Recent National Asthma Data. [Online]/ Available at: . Accessed September 2024. Quint JK, et al ; SABINA North American and European Study contributors. Short-Acting Beta-2-Agonist Exposure and Severe Asthma Exacerbations: SABINA Findings From Europe and North America. J Allergy Clin Immunol Pract . 2022; 10 (9): 2297-2309.e10. Pollack M, et al . The use of short-acting bronchodilators and cost burden of asthma across Global Initiative for Asthma-based severity levels: Insights from a large US commercial and managed Medicaid population. J Manag Care Spec Pharm 2022; 28(8):881-891. AstraZeneca. [Online]. Airsupra (PT027) approved in the US for asthma. Available at . Accessed September 2024. Papi A, et al . Albuterol–Budesonide Fixed-Dose Combination Rescue Inhaler for Asthma. N Engl J Med 2022; 386 (22): 2071-2083. Chipps BE, et al . Efficacy and safety of albuterol/budesonide (PT027) in mild-to-moderate asthma: Results of the DENALI study. Am J Respir Crit Care Med 2022; 205: A3414. Abstract. Available at: Accessed September 2024. Clinicaltrials.gov. Evaluating the Efficacy and Safety of PT027 Compared With PT007 Administered As Needed in Participants 12 to < 18 Years of Age With Asthma (ACADIA). Available at . Accessed September 2024. Clinicaltrials.gov. A Study to Investigate Efficacy and Safety of PT027 Compared With PT007 in Symptomatic Chinese Adults With Asthma (BAIYUN). Available at . Accessed September 2024. Global Initiative for Asthma. Global strategy for asthma management and prevention, 2022. Available at: . Accessed September 2024. Price D, et al . Asthma control and management in 8,000 European patients: the REcognise Asthma and LInk to Symptoms and Experience (REALISE) survey. NPJ Prim Care Respir Med . 2014; 24: 14009. Papi A, et al . Relationship of inhaled corticosteroid adherence to asthma exacerbations in patients with moderate-to-severe asthma. J Allergy Clin Immunol Pract . 2018; 6 (6): 1989-98.e3. AstraZeneca Pharmaceuticals. Data on File. Budesonide/formoterol Data on File: Annual Rate of Asthma Exacerbations Globally. (REF-173201) Sastre J, et al . Insights, attitudes, and perceptions about asthma and its treatment: a multinational survey of patients from Europe and Canada. World Allergy Organ J . 2016; 9: 13. Fernandes AG, et al . Risk factors for death in patients with severe asthma. J Bras Pneumol . 2014; 40 (4): 364-372. Wark PA, et al . Asthma exacerbations· 3: pathogenesis. Thorax . 2006; 61 (10): 909-15. Johnson DB, et al . Albuterol. 2022 May 1. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2022 Jan. PMID: 29489143. Montemayor T, et al . Albuterol: Often Used and Heavily Abused. Respiratory Care November 2021, 66 (Suppl 10) 3603775. ClinCalc.com. Albuterol: Drug Usage Statistics, US 2013 – 2020. Available at: . Accessed September 2024. Nwaru BI, et al . Overuse of short-acting β2-agonists in asthma is associated with increased risk of exacerbation and mortality: a nationwide cohort study of the global SABINA programme. Eur Respir J . 2020; 55 (4): 1901872. Lloyd A, et al . The impact of asthma exacerbations on health-related quality of life in moderate to severe asthma patients in the UK. Prim Care Respir J . 2007; 16 (1): 22-7. Bourdin A, et al . ERS/EAACI statement on severe exacerbations in asthma in adults: facts, priorities and key research questions. Eur Respir J . 2019; 54 (3): 1900900. Price DB, et al . Adverse outcomes from initiation of systemic corticosteroids for asthma: long-term observational study. J Asthma Allergy . 2018; 11: 193–204. Clinicaltrials.gov. A Comparison of PT027 vs PT007 Used as Needed in Participants With Asthma (BATURA). Available at Accessed September 2024. Contacts Media Inquiries Brendan McEvoy +1 302 885 2677 Jillian Gonzales +1 302 885 2677 US Media Mailbox: usmediateam@astrazeneca.com

Phase 3Clinical ResultDrug Approval

100 Deals associated with Salbutamol sulfate

External Link

KEGG	Wiki	ATC	Drug Bank
-	Salbutamol sulfate	R03CC02 R03AC02	DB01001

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Asthma, Exercise-Induced	US	Schering Corp.	01 May 1981
Bronchial Spasm	US	Schering Corp.	01 May 1981
Airway Obstruction	JP	GSK Plc	13 Jan 1973
Asthma	JP	GSK Plc	13 Jan 1973
Bronchitis	JP	GSK Plc	13 Jan 1973
Pulmonary Emphysema	JP	GSK Plc	13 Jan 1973
Pulmonary Tuberculosis	JP	GSK Plc	13 Jan 1973

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Acute asthma	NDA/BLA	CA	Intech Biopharm Ltd.	-
Persistent asthma	Phase 3	US	Teva Branded Pharmaceutical Products R&D, Inc.	01 Dec 2012
Childhood asthma	Phase 3	US	Teva Branded Pharmaceutical Products R&D, Inc.	10 Jun 2006
Pulmonary Disease, Chronic Obstructive	Phase 3	US	GSK Plc	01 Sep 2004
Pulmonary Disease, Chronic Obstructive	Phase 3	PR	GSK Plc	01 Sep 2004
Idiopathic Pulmonary Fibrosis	Phase 1	GB	GSK Plc	01 Apr 2012

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03199976 (CTgov)	Phase 4	Asthma \| Airway Obstruction \| Asthmatic bronchitis	80	Tiotropium Bromide+salbutamol (Tiotropium Bromide & Salbutamol)	jwdhdqlman(yikhgtlgii) = awghbsnzpz czdrndayjh (dskhyxhxdl, akfeymyipu - mvnykvfdtv) View more	-	19 Sep 2024
				salbutamol+Fluticasone Propionate (Fluticasone Propionate & Salbutamol)	jwdhdqlman(yikhgtlgii) = bwgolajjzq czdrndayjh (dskhyxhxdl, kfhdmpoper - isaixnzipi) View more
ATS2024	Not Applicable	-	-	Albuterol pMDI alone	jywileobuk(nflorhlsdl) = vzgjgisaii ihfcxqbolo (zcpbmlagin, 32 - 39)	-	19 May 2024
				Albuterol pMDI + VHC	jywileobuk(nflorhlsdl) = asnrszhkdq ihfcxqbolo (zcpbmlagin, 1.1 - 1.7)
NCT02508311 (CTgov)	Phase 4	Respiratory Paralysis \| Spinal Cord Injuries	1	Oral Albuterol Extended Release (Active Oral Beta-2)	ytohubabrs(rgoxmqlukm) = jhpmnrbltp thiligjrbm (zjajonbpud, uwasfnkuco - jtqweczuhu) View more	-	07 May 2024
				Placebo (Placebo)	ytohubabrs(rgoxmqlukm) = vqfqpafmbo thiligjrbm (zjajonbpud, ljwfnlmbyc - ygadkaecca) View more
NCT00521222 (ARGARG, CTgov)	Not Applicable	Asthma	90	Albuterol HFA+Ipratropium HFA+Fluticasone (Arg/Arg Genotype on Advair (Fluticasone With Salmeterol) HFA)	odjbhsbzyv(tswckigstr) = cbqntxwfup zzzzozqzrp (xwsydfoyfw, zhapannygn - gqyrpyvwrz) View more	-	21 Apr 2023
				Albuterol HFA+Ipratropium HFA+Fluticasone (Gly/Gly Genotype on Advair (Fluticasone With Salmeterol) HFA)	odjbhsbzyv(tswckigstr) = raexcbrzbt zzzzozqzrp (xwsydfoyfw, bjwvhxgkeo - pqrqibpooy) View more
NCT04677959 (CONNECT2, CTgov)	Phase 4	Asthma	427	Albuterol+Fluticasone propionate/salmeterol (FS)	uedfguwlwx(yzvhrcfien) = iiidvkeggn khylpplsoa (sfirwwfpbj, ssbrvwqrmh - jeldeameze) View more	-	14 Mar 2023
NCT03890666 (CONNECT1, CTgov)	Phase 4	Asthma	333	albuterol (Concurrent Control (CC))	qdisrcxzdn(dioxgyepcb) = bqqzcxrydk xymhxqyepy (zwdgtluoad, kttdhvegzj - neydzwiuyv) View more	-	27 Oct 2022
				Albuterol eMDPI DS (Digital System (DS))	qdisrcxzdn(dioxgyepcb) = qjvopranvb xymhxqyepy (zwdgtluoad, pebvbkjerg - cdqrxpavhw) View more
ERS2022	Not Applicable	Pulmonary Disease, Chronic Obstructive	58	Salbutamol	jpvnqyhtsp(nnulrqnesa) = irqdkofhwx pdbyboncso (pnauucalod ) View more	Positive	04 Sep 2022
				Salbutamol	jpvnqyhtsp(nnulrqnesa) = vulkfdmpwk pdbyboncso (pnauucalod ) View more
ERS2022	Not Applicable	Cardiovascular Diseases	-	Salbutamol	jieacqlupx(opzozboiwy) = Salbutamol was associated with a very common risk of palpitations or tachycardia, suggesting more clinical vigilance lhftxmughy (lgwsklaujb )	Negative	04 Sep 2022
NCT00530062 (CTgov)	Phase 4	Asthma	49	Albuterol-HFA-BAI (Albuterol-HFA-BAI)	gtaexesawt(zgxqgjkyzo) = wszfhxmbqq kqmitzdpba (rdpuuxwzqd, jfhxryzbxr - sfhnfnfmmp) View more	-	31 Aug 2022
				Albuterol-HFA-MDI (Albuterol-HFA-MDI)	gtaexesawt(zgxqgjkyzo) = licmsyoapd kqmitzdpba (rdpuuxwzqd, sknvcbitby - vxldqegogg) View more
NCT00308685 (CTgov)	Phase 3	Childhood asthma	95	Albuterol (Albuterol-HFA-BAI)	rdgjvkuhix(ulebjkcxcw) = ibmguxjffe wjqcvwiurw (jrtxymgrxv, hcjupjgqhr - uneoollrlj) View more	-	24 Feb 2022
				Placebo (Placebo-HFA-BAI)	rdgjvkuhix(ulebjkcxcw) = wpqujzdlfg wjqcvwiurw (jrtxymgrxv, zgvhehaffm - nhzsegdryg) View more

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