[Translation] A clinical trial evaluating the pharmacokinetics, safety, and tolerability of aclidinium bromide/formoterol fumarate in Chinese patients with moderate to severe chronic obstructive pulmonary disease

对处于稳定期的中重度 COPD 中国患者进行为期 5 天的阿地溴铵／福莫特罗 400μg/12μg 每日二次给药，评估阿地溴铵、其代谢物 LAS34850 和 LAS34823 以及福莫特罗的药代动力学特性，同时评估安全性和耐受性。

[Translation]

Methods: Aclidinium/formoterol 400 μg/12 μg twice daily was administered to Chinese patients with stable moderate to severe COPD for 5 days to evaluate the pharmacokinetic properties of aclidinium, its metabolites LAS34850 and LAS34823, and formoterol, and to assess safety and tolerability.

Start Date08 Dec 2017

Sponsor / Collaborator

Industrias Farmacéuticas Almirall SA

[+2]

NCT03181880

/ WithdrawnPhase 4

To Evaluate Effectiveness of Aclidinium Bromide/Formoterol Fumarate Dihydrate in Chronic Obstructive Pulmonary Disease

ASTUTE is a pragmatic open randomised 12-week multinational trial to evaluate the effectiveness of aclidinium bromide/formoterol fumarate dihydrate fixed-dose combination compared to standard of care bronchodilators in chronic obstructive pulmonary disease.

Start Date04 Dec 2017

Sponsor / Collaborator

AstraZeneca PLC

[+1]

NCT03276078

/ CompletedPhase 2

A Phase IIa, Open-Label, Repeat-Dose Clinical Trial to Evaluate the Pharmacokinetics, Safety and Tolerability of Aclidinium Bromide/Formoterol Fumarate Fixed Dose Combination Administered Twice-Daily by Inhalation in Chinese Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease

A Phase IIa, open-label, repeat-dose trial to investigate the pharmacokinetics (PK), safety and tolerability of single and multiple twice daily doses of inhaled Aclidinium Bromide/Formoterol Fumarate 400/12 μg in 20 Chinese male and female patients with stable moderate to severe COPD.

Start Date23 Nov 2017

Sponsor / Collaborator

AstraZeneca PLC

100 Clinical Results associated with Aclidinium Bromide/Formoterol Fumarate

100 Translational Medicine associated with Aclidinium Bromide/Formoterol Fumarate

100 Patents (Medical) associated with Aclidinium Bromide/Formoterol Fumarate

Literatures (Medical) associated with Aclidinium Bromide/Formoterol Fumarate

01 Jul 2019·P & T : a peer-reviewed journal for formulary management

Pharmaceutical Approval Update.

Article

Author: Choy, Mary

Mavenclad (cladribine) tablets for relapsing MS forms; Duaklir Pressair (aclidinium bromide/formoterol fumarate) inhalant for COPD; Evenity (romosozumab-aqqg) injection for osteoporosis.

01 Jan 2018·Therapeutic delivery

An Industry update: the Latest Developments in Therapeutic Delivery

Article

Author: Simpson, Iain

This industry update covers the period from 1 September through 30 September 2017, and is based on information sourced from company press releases, scientific literature, patents and various news websites. The month saw the US FDA approve three new molecular entities, Aliqopa (copanlisib dihydrochloride) (Bayer Healthcare); Solosec (secnidazole) (Symbiomix Therapeutics) and Verzenio (abemaciclib) (Eli Lilly and Co). Intarcia Therapeutics Inc. has its application for approval of a novel drug device combination of exenatide for the treatment of diabetes rejected by FDA but said that it will work to address the concerns and refile the application. The impact of biosimilars in the market is steadily increasing with seven biosimilars approved in the USA and Sandoz hoping to add to this with its announcement that FDA has accepted its Biologics License Application for a biosimilar version of Roche's Rituxan. Circassia announced positive top line results of a respiratory drug, Duaklir (for the treatment of chronic obstructive pulmonary disease) and Sarepta (for its new treatment for Duchenne muscular dystrophy). Axovant Sciences Ltd announced the failure if its drug Intepirdine in the treatment of Alzheimer's, adding to a growing list of drug failures in this area. There were a number of developments in the area of oncology with Bristol-Myers Squibb and Infinity Pharmaceuticals announcing an expansion of their collaboration looking at combination treatments, as well as Eli Lilly and Co's approval for Verzenio. Rani Therapeutics and Intra-Cellular Therapies announced successful funding rounds to support their drug programs. Allergan announced a novel licensing deal for its dry eye drug, Restasis, which it hopes would allow it to stave off patent challenges from several companies looking to develop generic versions of the drug. New research suggests that loss of sense of smell can be linked to an increased risk of developing Parkinson's disease.

01 Jul 2016·Respiratory medicineQ3 · MEDICINE

Long-term safety of aclidinium bromide/formoterol fumarate fixed-dose combination: Results of a randomized 1-year trial in patients with COPD

Q3 · MEDICINE

Article

Author: Wu, Xiao ; Shrestha, Pomy ; Lei, Alejhandra ; Soong, Weily ; Donohue, James F

TRIAL DESIGN:

This was a one-year, Phase III randomized, double-blind, parallel-group, active-control study investigating the long-term safety and tolerability of twice-daily aclidinium 400 μg/formoterol 12 μg versus formoterol 12 μg.

METHODS:

Eligible patients were male or female, current or ex-smokers (history of ≥10 pack-years) aged ≥40 years with a diagnosis of moderate to severe chronic obstructive pulmonary disease (COPD): post-bronchodilator forced expiratory volume in 1 s (FEV1)/forced vital capacity (FVC) ratio <70%, and post-bronchodilator FEV1≥30% and <80% predicted. Patients were randomized 2:1 to twice-daily aclidinium 400 μg/formoterol 12 μg or formoterol 12 μg, administered via a multidose dry powder inhaler (Genuair™/Pressair(®))(1). The objective was to evaluate the one-year safety of aclidinium 400 μg/formoterol 12 μg versus formoterol 12 μg.

RESULTS:

All 590 patients were included in the safety population; 392 patients received aclidinium 400 μg/formoterol 12 μg and 198 patients received formoterol 12 μg. Of these, 581 patients were included in the intent-to-treat (ITT) population (385 patients received aclidinium 400 μg/formoterol 12 μg; 196 patients received formoterol 12 μg). In the safety population, the percentage of patients with ≥1 treatment-emergent adverse event was similar between aclidinium 400 μg/formoterol 12 μg (71.4%) and formoterol 12 μg (65.7%). Mean baseline post-bronchodilator FEV1 was 51.3% of predicted (ITT population). Aclidinium 400 μg/formoterol 12 μg significantly improved morning pre-dose (trough) FEV1 and trough FVC versus formoterol 12 μg at each assessment, with improvements at Week 1 (least squares mean difference [LSMD]: 87.4 mL and 157.8 mL, respectively) maintained at study end (LSMD: 81.5 mL and 185.4 mL, respectively).

CONCLUSIONS:

Aclidinium 400 μg/formoterol 12 μg was well tolerated, with a safety profile similar to formoterol 12 μg and consistent with that seen in two Phase III studies. Additionally, aclidinium 400 μg/formoterol 12 μg improved lung function versus formoterol 12 μg, with a sustained effect over one year.

News (Medical) associated with Aclidinium Bromide/Formoterol Fumarate

10 Oct 2023

·synapse.patsnap.com

Inventory of GPCR Targeted Drugs Applying for Listing (I)

This article will review currently applied listed GPCR-targeting drugs, and the associated popular GPCR class targets and drug development opportunities worth paying attention to. 1.Eli Lilly: TirzepatideTarget:GIPR + GLP-1R Tirzepatide is a novel GIPR and GLP-1R dual agonist developed by Eli Lilly. In preclinical and clinical trials, compared to selective GLP-1 receptor agonists, GIP/GLP-1 dual agonists have been shown to better control blood sugar and reduce weight. Therefore, it is receiving increasing attention as a new therapeutic drug for controlling blood sugar and weight. In 2022, Tirzepatide was approved for the first time in the United States for the treatment of adult type II diabetes as an adjunct to diet and exercise. Subsequently, Tirzepatide was approved in the European Union and Japan for the treatment of type II diabetes. 👇Please click on the image below to directly access the latest data (R&D Status | Core Patent | Clinical Trial | Approval status in Global countries) of this drug. 2.ChemoCentryx: AvacopanTarget:C5aR Avacopan(Tavneos) is an orally administered, first-in-class selective complement 5a receptor (C5aR) antagonist, discovered and developed by ChemoCentryx. This drug is used as an adjunctive therapy for ANCA-associated vasculitis in adult patients. Anti-neutrophil cytoplasmic antibody-associated vasculitis (AAV) is a rare ("oligo-immune") systemic small-vessel vasculitis, with an estimated incidence of 3 per 100,000 annually, characterized by the presence of ANCAs in the serum. The entire course of AAV includes granulomatosis with polyangiitis (GPA), microscopic polyangiitis (MPA), eosinophilic granulomatosis with polyangiitis (EGPA), and drug-induced AAV. Despite its complex pathophysiology, research over the past approx. 20 years has determined the crucial role of the alternative complement pathway, particularly the interaction of C5a with the C5aR receptor in AAV. Avacopan was first approved for marketing in Japan on September 27, 2021, and was subsequently approved in the United States, European Union, Canada, and Australia for the treatment of adult patients with ANCA-associated vasculitis, granulomatosis with polyangiitis, and microscopic polyangiitis. In addition, research is ongoing for other potential clinical indications, such as hidradenitis suppurativa and C3 glomerulopathy. 3.Pfizer: Rimegepant Sulfate Target:CGRP Receptor Rimegepant is an orally administered CGRP receptor antagonist used for the acute treatment of migraine in adults, with or without aura. Initially developed by the BMS(BMS-742413), the newly established biotech company Biohaven Pharmaceutical acquired the exclusive global development and commercialization rights to Rimegepant in 2016. The Biohaven team conducted a series of clinical studies and analyses around Rimegepant and developed the derivative migraine nasal spray drug, Zavegepant. In May 2022, Pfizer announced that it would acquire Biohaven for a total cash consideration of approximately 11.6 billion USD. Rimegepant was first approved for marketing in the United States on February 27, 2020, and subsequently received approval in Israel, the United Arab Emirates, Kuwait, the European Union, and Iceland, among others. Currently, the drug is being tested in clinical trials for conditions like chronic sinusitis, nasal polyps, and trigeminal neuralgia. 4. Glenmark:RYALTRISTarget:H1R+GR RYALTRIS is a new compound prescription nasal spray developed by the Indian pharmaceutical company, Glenmark. This medication has the dual efficacy of activating glucocorticoid receptor (GR) and antagonizing histamine H1 receptor (H1R). Mometasone is a moderately potent synthetic corticosteroid that acts as a glucocorticoid receptor agonist, possessing anti-inflammatory, anti-itch, and vasoconstrictive properties. Olopatadine, on the other hand, is an antagonist of histamine H1 receptors used for the treatment of allergic conjunctivitis and rhinitis. Since histamine is the primary inflammatory mediator causing inflammation and allergic reactions, Olopatadine works by blocking the action of histamine receptors. Compared to other anti-allergic ophthalmic drugs, Olopatadine does not interfere with the cell membrane, thus offering good comfort and tolerability. RYALTRIS was first approved for marketing in Australia in 2019, and subsequently received approval for listing in South Africa, the UK, the US, Canada, and other countries. In 2019, Grand Pharmaceutical and Glenmark signed an exclusive licensing agreement, in which Glenmark granted Grand Pharmaceutical the exclusive rights to sell RYALTRIS in China. Glenmark would be responsible for the manufacture and supply of the authorized product, while Grand Pharmaceutical would be in charge of the clinical trials and registration work for the authorized product in China and can exclusively sell the approved product in China for 20 years upon approval. 5. Amgen:ErenumabTarget:CGRP Erenumab is a human monoclonal antibody developed by Amgen and is the first monoclonal antibody drug targeting GPCR approved by the FDA. Erenumab can specifically bind to and antagonize the Calcitonin Gene-Related Peptide Receptor (CGRPR), thus preventing migraines. In April 2017, Amgen announced an expanded commercial collaboration with Novartis on Erenumab, which is being studied for the prevention of migraine. This expanded business cooperation is based on the global neuroscience collaboration established by Novartis and Amgen in 2015 in the areas of Alzheimer's disease and migraine. Novartis initiated two clinical trials in China in 2019 to evaluate the safety and efficacy of Erenumab injection in the treatment of migraines. Erenumab was first approved for marketing in the United States in 2018, and was subsequently approved in Australia, Iceland, Norway, Switzerland, Canada, and Japan. In addition to the treatment of migraines, clinical trial research is ongoing for other indications, including headaches, hot flashes, temporomandibular joint dysfunction syndrome, stable angina. 6. Kyowa Kirin:EvocalcetTarget:CaSR Evocalcet is a Calcium-Sensing Receptor (CaSR) agonist developed by Kyowa Kirin, used for the treatment of hypercalcemia, secondary hyperparathyroidism, and other related conditions. Kyowa Kirin has applied for two clinical trials in China to evaluate the effectiveness of Evocalcet in treating secondary hyperparathyroidism in patients undergoing maintenance dialysis for chronic kidney disease. As of now, Evocalcet has only been approved for marketing in Japan. 7. Otsuka Pharmaceutical: BrexpiprazoleTarget:5-HT1A+5-HT2A+D2R Brexpiprazole is a serotonin-dopamine activity modulator developed by Otsuka Pharmaceutical, used as an adjunctive treatment for severe depression, schizophrenia, and agitation associated with dementia caused by Alzheimer's disease. Brexpiprazole is an atypical antipsychotic and a novel D2 dopamine and serotonin 1A partial agonist, known as a serotonin-dopamine activity modulator. It has a high affinity for serotonin, dopamine, and alpha-adrenergic receptors. Structurally, Brexpiprazole is very similar to another atypical antipsychotic drug, Aripiprazole, but Brexpiprazole has a different affinity for binding with dopamine and serotonin receptors. Compared to Aripiprazole, Brexpiprazole is less likely to produce adverse reactions mediated by partial agonist, such as extrapyramidal symptoms, due to its lower intrinsic activity at the D2 receptor. Brexpiprazole was first approved in the United States in 2015, and subsequently approved in Canada, Japan, and the European Union. In addition to treating depression, this drug is undergoing global clinical trials and research for multiple indications including agitation, schizophrenia, Alzheimer's disease, and performance anxiety. 8. Santen: TapcomTarget:PTGFR+βAR Tapcom is a combination eye drop medication containing Tafluprost and Timolol Maleate, developed by Santen. Tafluprost is a prostaglandin analogue used in ophthalmology to reduce intraocular pressure in patients with ocular hypertension or open-angle glaucoma. Chemically, Tafluprost is a fluorinated analogue of prostaglandin F2-α. Timolol is a non-selective beta-adrenergic antagonist, used for the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma. Tapcom was first approved for marketing in Japan in 2013, and subsequently received approval in countries including Iceland, France, Poland, and Germany. 9. Takeda:TeduglutideTarget:GLP-2R Teduglutide is a glucagon-like peptide-2 (GLP-2) analog developed by the British rare disease pharmaceutical giant, Shire Development, for the treatment of patients with short bowel syndrome (SBS) who require parenteral nutrition support. Teduglutide is comprised of 33 amino acids, and is manufactured using strains of E. coli that have been modified through DNA recombinant technology. Teduglutide differs from GLP-2 by one amino acid (alanine is replaced with glycine). This substitution results in Teduglutide having a longer duration of action than endogenous GLP-2 and a higher resistance to hydrolysis by the enzyme dipeptidyl peptidase-4. Teduglutide first received regulatory approval within the European Union in 2012, followed by approval in the United States and Japan, in all cases for the treatment of SBS. In 2019, Takeda Pharmaceuticals spent an astounding £46 billion to acquire Shire Development, in a move that has been dubbed as a "snake swallowing an elephant" merger in the pharmaceutical world. This acquisition propelled Takeda Pharmaceuticals into the list of top 10 global biopharmaceutical companies. Clinical research on the application of Teduglutide for the treatment of Crohn's Disease and kidney disorders was discontinued due to this acquisition. 10. AstraZeneca: Duaklir GenuairTarget:M3R+β2AR Duaklir Genuair is a combined Aclidinium Bromide/Formoterol Fumarate inhalation powder developed by AstraZeneca. This medication is used as a maintenance bronchodilator to alleviate the symptoms of disease in adults with chronic obstructive pulmonary disease (COPD). Among them, Aclidinium bromide is a novel long-acting muscarinic antagonist, and Formoterol fumarate is a long-acting β2 receptor agonist. Duaklir Genuair is administered by the Genuair dry powder inhaler twice a day and is the first combined medication that has shown a statistically significant improvement over monotherapy in terms of shortness of breath. Duaklir Genuair was first approved in the European Union in 2012, and subsequently in the United States in 2019, for the treatment of chronic obstructive pulmonary disease.

25 Jan 2023

·www.prnewswire.com

The Worldwide Chronic Obstructive Pulmonary Disease (COPD) Industry is Expected to Reach $22.9 Billion by 2028

DUBLIN, Jan. 25, 2023 /PRNewswire/ -- The "Chronic Obstructive Pulmonary Disease (COPD) Market, Global Forecast 2023-2028, Industry Trends, Growth, Insight, Impact of Inflation, Company Analysis" report has been added to ResearchAndMarkets.com's offering. The Global Chronic Obstructive Pulmonary Disease (COPD) Market will increase to around USD 22.91 Billion by 2028 according to the publisher. Chronic inflammatory lung disease causes breathing difficulties. It is a group of progressive lung diseases. The most common diseases are emphysema and chronic bronchitis. COPD, if left untreated, can lead to worsening respiratory infection, heart problems, and the progression of various other diseases. COPD is commonly caused due to smoking tobacco-related products. The longer and more tobacco products an individual smokes, the greater risk of having COPD. Cigarette smoking, cigar smoke, pipe smoke, and second-hand smoke can also cause COPD. According to World Health Organization (WHO), COPD is considered the third leading cause of death worldwide, and nearly 90% of Global Chronic Obstructive Pulmonary Disease deaths in those under 70 years of age occur in low and medium income countries (LMIC). Worldwide Chronic Obstructive Pulmonary Disease Market will grow at a CAGR of 5.73% from 2022 to 2028 The rise in the incidence of COPD is the major contributor to the market's growth. In addition, people's lifestyle change is responsible for increasing habits like smoking and drinking. The other factors that influence the growth of the COPD market are a rise in demand for medications for the treatment of COPD symptoms, an increase in funding for R&D and drug production by government and pharmaceutical companies, growing awareness among people across developing and underdeveloped countries, are boosting the growth of the market companies. Nevertheless, the high cost of COPD treatment and lack of knowledge about COPD is anticipated to hinder the market's growth. Also, factors like patent expiry for medical devices will restrict the development of the market. Chronic Bronchitis will lead in Chronic Obstructive Pulmonary Disease Market Based on type, the global COPD market is categorized into; chronic bronchitis and emphysema. The chronic bronchitis category dominates the market share of the worldwide COPD market. The reason for its dominance is the growing incidence and prevalence of chronic bronchitis worldwide, due to the rise in the consumption of cigarettes and the increase in industrialization, which results in air pollution and the release of harmful gases into the environment. Drug remain the most important segment in Treatment Type Based on treatment, the global COPD market is divided into; drugs, oxygen therapy, surgery, and others. The drugs segment has a higher market share in the market, owing to the increasing use of drugs as the first line of treatment for COPD to make breathing easier by widening airways. The oxygen therapy market is also expected to surge at a significant CAGR rate in the forecast period. The growth can be attributed to factors like the rapid growth of the geriatric population, the rising prevalence of tobacco smoking, the development of respiratory disorders, the increase in the usage of home-based oxygen therapy, and technological advancements. Rise in Number of COPD Therapeutics Dispensed to boost the hospital Segment The distribution channels can be segmented into; hospital pharmacies, retail pharmacies, and online pharmacies. The hospital pharmacies segment has a high market share. The dominance due to the rising number of patients suffering from chronic respiratory diseases and rising awareness about these diseases. Furthermore, the availability of various diagnostics and treatment facilities and higher purchasing power has contributed to the segment's growth. North American area dominates the COPD Industry The report divides the region into; North America, Europe, Asia-Pacific, Latin America, and Middle-East & Africa. The North American area dominates the market share. This can be attributed to increased investment in R&D activities to develop innovative drugs for treating diseases. Also, the rise in an older population, rising incidence and prevalence of chronic respiratory diseases, technological advancement, growing healthcare sectors, and massive presence of leading market players are some of the major factors that boost the COPD Market in the region. The Asia-Pacific region is forecasted to have significant growth, owing to increasing focus on the development of healthcare infrastructure, rising prevalence of various chronic respiratory diseases along with lifestyle diseases, rise in industrialization, changes in the lifestyle, and increase in the patient population suffering from COPD in the developing nations such as China, and India. According to our research report, Worldwide Chronic Obstructive Pulmonary Disease (COPD) Market was at US$ 16.40 Billion in 2022. Key Players in Chronic Obstructive Pulmonary Disease Market COPD market is consolidated with the presence of a small number of key players. Also, the key players are constantly involved in product innovation and development, technological advancements, agreements, mergers, and acquisitions to procure a higher market share. The key players in the market are; AstraZeneca, Pfizer Inc., GlaxoSmithKline Plc, Novartis AG, Astellas Pharma, Abbott Laboratories, Boehringer Ingelheim International GmbH, and Almirall. For instance, In Nov 2021, AstraZeneca announced that sold rights to sell Tudorza, also known as Eklira abroad, and Duaklir to the Switzerland-based pharmaceutical company CovisPharma Group for US$ 270 Mn. These products are indicated for treating chronic obstructive pulmonary disease (COPD). Key Topics Covered: 1. Introduction 2. Research & Methodology 3. Executive Summary 4. Market Dynamics 4.1 Growth Drivers 4.2 Challenges 5. Global Chronic Obstructive Pulmonary Disease Copd Market 6. Market Share - Global Acute Respiratory Distress Syndrome 6.1 By Type 6.2 By Treatment 6.3 By Distribution Channels 6.4 By Regions 7. Types - Chronic Obstructive Pulmonary Disease Copd Market 7.1 Chronic Bronchitis 7.2 Emphysema 8. Treatment Types -Chronic Obstructive Pulmonary Disease Copd Market 8.1 Drugs 8.2 Oxygen Therapy 8.3 Surgery 8.4 Others 9. Distribution Channels -Chronic Obstructive Pulmonary Disease Copd Market 9.1 Hospital Phamacies 9.2 Retail Pharmacies 9.3 Online Pharmacies 10. Regions - Chronic Obstructive Pulmonary Disease Copd Market 10.1 North America 10.2 Europe 10.3 Asia - Pacific 10.4 Latin America 10.5 Middle East & Africa 11. Company Analysis 11.1 AstraZeneca 11.1.1 Overview 11.1.2 Recent Developments 11.1.3 Sales Analysis 11.2 Pfizer, Inc. 11.2.1 Overview 11.2.2 Recent Developments 11.2.3 Sales Analysis 11.3 GlaxoSmithKline plc. 11.3.1 Overview 11.3.2 Recent Developments 11.3.3 Sales Analysis 11.4 Novartis AG 11.4.1 Overview 11.4.2 Recent Developments 11.4.3 Sales Analysis 11.5 AstellasPharma Inc. 11.5.1 Overview 11.5.2 Recent Developments 11.5.3 Sales Analysis 11.6 Abbott Laboratories 11.6.1 Overview 11.6.2 Recent Developments 11.6.3 Sales Analysis 11.7 BoehringerIngelheim International GmbH 11.7.1 Overview 11.7.2 Recent Developments 11.7.3 Sales Analysis 11.8 Almirall 11.8.1 Overview 11.8.2 Recent Developments 11.8.3 Sales Analysis For more information about this report visit Media Contact: Research and Markets Laura Wood, Senior Manager [email protected] For E.S.T Office Hours Call +1-917-300-0470 For U.S./CAN Toll Free Call +1-800-526-8630 For GMT Office Hours Call +353-1-416-8900 U.S. Fax: 646-607-1907 Fax (outside U.S.): +353-1-481-1716 Logo: SOURCE Research and Markets

28 Oct 2022

·www.globenewswire.com

Covis Pharma Announces Positive Topline Results from the AVANT Phase 3 Clinical Trial Showing Significant Improvement in Patients with Moderate to Severe Stable COPD

ZUG, Switzerland, Oct. 25, 2022 (GLOBE NEWSWIRE) -- Covis Pharma Group (“Covis”), a global specialty pharmaceutical company that markets therapeutic solutions for patients with life-threatening conditions and chronic illnesses, today announced positive topline results from the AVANT phase 3 clinical trial for Duaklir® (aclidinium bromide 400µg /formoterol 12µg twice-daily) and Eklira® (aclidinium bromide 400µg twice-daily) – known as Tudorza® in the U.S. This 24-week study achieved statistically significant and clinically important outcomes for all key endpoint measures of efficacy in adult patients with moderate to severe stable chronic obstructive pulmonary disease (COPD). The primary efficacy endpoints of the study were a change in baseline of FEV1 of the 1-hour morning post-dose FEV1 for aclidinium/formoterol versus aclidinium, and the change from baseline of the morning pre-dose FEV1 of aclidinium/formoterol versus formoterol and aclidinium versus placebo. A total of 1,060 patients with moderate to severe stable COPD were included in the trial. Seventy percent of the participants were from China, with other participants coming from Taiwan, India, Vietnam, and the Philippines. Patients were randomized equally to placebo, aclidinium bromide monotherapy (Eklira), aclidinium bromide/formoterol fumarate combination therapy (Duaklir), and monotherapy formoterol for a 24-week period. There were no new safety concerns raised in the study and the findings were consistent with the known safety profiles of aclidinium bromide and aclidinium bromide/formoterol. The safety and tolerability of both aclidinium and aclidinium/formoterol were comparable to placebo. AstraZeneca, who performed the study, transferred its global rights for Duaklir and Eklira to Covis in November 2021. “The positive results from this phase 3 clinical trial demonstrate a promising step to expand our global respiratory portfolio into important new regions,” said Raghav Chari, PhD, Chief Innovation Officer at Covis Pharma. “These data further strengthen our confidence in these two medicines and support our intent to pursue the regulatory path to make these treatment options available to a broader population of COPD patients.” Detailed results of the study are planned for future publication. A full analysis of the AVANT data is ongoing with complete results to be provided, or submitted with the AVANT NDA, to the China Food and Drug Administration (CFDA). About the Medicines Eklira (aclidinium bromide) and Duaklir (aclidinium bromide/formoterol) are inhaled respiratory medicines used for the maintenance treatment of COPD. Eklira is a long-acting muscarinic antagonist (LAMA), which is marketed in the US as Tudorza and in some countries as Bretaris®. Duaklir is a combination therapy that contains both a LAMA and a long-acting beta2-agonist (LABA). It is marketed in some countries as Brimica®. Both medicines are presented as a dry powder for oral inhalation and are delivered via a breath-actuated multi-dose dry powder inhaler, Genuair® (Pressair® in the US). About Covis Pharma Covis Pharma, founded in 2011 and headquartered in Luxembourg, is a global specialty pharmaceutical company that markets therapeutic solutions for patients with life-threatening conditions and chronic illnesses. Additional information on the Company is available at www.covispharma.com.

Clinical ResultPhase 3

100 Deals associated with Aclidinium Bromide/Formoterol Fumarate

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	R03AL05	-

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Pulmonary Disease, Chronic Obstructive	European Union	Covis Pharma Europe BV	19 Nov 2014
Pulmonary Disease, Chronic Obstructive	Iceland	Covis Pharma Europe BV	19 Nov 2014
Pulmonary Disease, Chronic Obstructive	Liechtenstein	Covis Pharma Europe BV	19 Nov 2014
Pulmonary Disease, Chronic Obstructive	Norway	Covis Pharma Europe BV	19 Nov 2014

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Moderate chronic obstructive pulmonary disease	Phase 3	India	Wuxi Clinical Development Services (Shanghai) Co., Ltd.	02 Feb 2017
Moderate chronic obstructive pulmonary disease	Phase 3	India	Almirall SA	02 Feb 2017
Moderate chronic obstructive pulmonary disease	Phase 3	Philippines	Almirall SA	02 Feb 2017
Moderate chronic obstructive pulmonary disease	Phase 3	Philippines	Wuxi Clinical Development Services (Shanghai) Co., Ltd.	02 Feb 2017
Moderate chronic obstructive pulmonary disease	Phase 3	Vietnam	Wuxi Clinical Development Services (Shanghai) Co., Ltd.	02 Feb 2017
Moderate chronic obstructive pulmonary disease	Phase 3	Vietnam	Almirall SA	02 Feb 2017
Severe chronic obstructive pulmonary disease	Phase 3	India	Almirall SA	02 Feb 2017
Severe chronic obstructive pulmonary disease	Phase 3	India	Wuxi Clinical Development Services (Shanghai) Co., Ltd.	02 Feb 2017
Severe chronic obstructive pulmonary disease	Phase 3	Philippines	Almirall SA	02 Feb 2017
Severe chronic obstructive pulmonary disease	Phase 3	Philippines	Wuxi Clinical Development Services (Shanghai) Co., Ltd.	02 Feb 2017

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03022097 (AVANT, CTgov)	Phase 3	Pulmonary Disease, Chronic Obstructive	1,625	Placebo	hsjhhumkpd(vkdztcxhkd) = fntsnqqejh wfqvusesgm (eqauijbwwf, 0.013) View more	-	26 Mar 2025
NCT02424344 (ACTIVATE, Pubmed \| Int J Chron Obstruct Pulmon Dis)	Phase 4	Pulmonary Disease, Chronic Obstructive	250	Aclidinium bromide/formoterol fumarate	jtobklcrmh(xsbxiszmxp) = xkvizovjur gvenietxln (nbcqpbjbda, (27.7))	-	01 Jan 2022
ERS2020	Not Applicable	Pulmonary Disease, Chronic Obstructive	-	Aclidinium bromide (AB)	gbdkfzprou(dfdswrdplo) = jzxadqbyct diuparaxja (yfrcsbngoc )	-	07 Sep 2020
NCT03276078 (CTgov)	Phase 2	Pulmonary Disease, Chronic Obstructive	20	Formoterol Fumarate+Aclidinium bromide	zgctqptvsd(zstilosney) = pidxxtadmp hlkfwdxcgd (jhnugbksuu, 84.54) View more	-	22 Jul 2019
NCT02796677 (AMPLIFY \| D6571C00001, Pubmed \| Int J Chron Obstruct Pulmon Dis)	Phase 3	Pulmonary Disease, Chronic Obstructive	1,595	aclidinium bromide/formoterol fumarate (AB/FF) 400/12 µg	psottcmwvz(ebnoacdtpd) = xgphqogdib antnpdjjmb (naqdmmccrf )	Positive	01 Jan 2019
				aclidinium bromide (AB) 400 µg	psottcmwvz(ebnoacdtpd) = qgqfsewjrl antnpdjjmb (naqdmmccrf )
NCT02796677 (AMPLIFY \| D6571C00001, CTgov)	Phase 3	Pulmonary Disease, Chronic Obstructive	1,595	AB (AB/FF 400/12 μg)	iinfjwfgbh(dhyxbhjvph) = zlcifmmour hxzkadpfmj (azjqfudqvs, 0.013) View more	-	09 Nov 2018
				AB (AB 400 μg)	iinfjwfgbh(dhyxbhjvph) = ehtlkmjjhc hxzkadpfmj (azjqfudqvs, 0.011) View more
NCT02424344 (ACTIVATE, CTgov)	Phase 4	Pulmonary Disease, Chronic Obstructive	267	AB (AB/FF 400/12 μg)	ykpeuqmihh(xskqsbuuiu) = nxbdrysyfl ljgdkxbhyt (qpngkemmni, 0.050) View more	-	09 Oct 2018
				Placebo+Formoterol+Aclidinium (Placebo)	ykpeuqmihh(xskqsbuuiu) = lharvbbyld ljgdkxbhyt (qpngkemmni, 0.050) View more
NCT00706914 (CTgov)	Phase 2	Pulmonary Disease, Chronic Obstructive	156	Placebo to formoterol fumarate+Once-daily aclidinium/formoterol (Once-daily Aclidinium/Formoterol)	vhvrmkdaae(kggtddqyzu) = labjfawvur cctfdgpvmf (cohmnjzffr, hlygknlnkr - kyiccrvqkl) View more	-	15 May 2017
				Once-daily formoterol fumarate+Once-daily aclidinium/formoterol (Morning Aclidinium/Formoterol Plus Evening Formoterol)	vhvrmkdaae(kggtddqyzu) = nzkrvknqpj cctfdgpvmf (cohmnjzffr, dowwfqhpte - poyqtogwrg) View more
NCT01437540 (CTgov)	Phase 3	Pulmonary Disease, Chronic Obstructive	590	Formoterol+Aclidinium (Aclidinium/Formoterol 400 μg/12 μg)	nbwmybmcoy = vfmbndrbtn dvorfxyknh (uxeudhadwf, agnrqdnznp - ozfjashkee) View more	-	11 May 2017
				Formoterol (Formoterol 12 μg)	nbwmybmcoy = iptnfwgaav dvorfxyknh (uxeudhadwf, tyjpyqhzun - pjwapzxzyu) View more
NCT01462942 (ACLIFORM-COPD, CTgov)	Phase 3	Pulmonary Disease, Chronic Obstructive	2,443	Placebo (Placebo)	ilmvhtfiyw(nlyljasibo) = lqogwxykez tjubruwnlf (nnrhxlgdxc, 0.018) View more	-	15 Feb 2017
				Aclidinium Bromide/Formoterol Fumarate (Aclidinium/Formoterol 400/12 μg)	ilmvhtfiyw(nlyljasibo) = vxjekioico tjubruwnlf (nnrhxlgdxc, 0.013) View more

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