A5077419098- Inhalation and Respiratory Drug Delivery
- Chronic Obstructive Pulmonary Disease (COPD) Research
- Asthma and respiratory diseases
- Respiratory and Cough-Related Research
- Respiratory Support and Mechanisms
- Pharmaceutical studies and practices
- Allergic Rhinitis and Sensitization
- Interstitial Lung Diseases and Idiopathic Pulmonary Fibrosis
- Pediatric health and respiratory diseases
- Advanced Chemical Sensor Technologies
- Heart Rate Variability and Autonomic Control
- Pharmacological Effects and Assays
- Nutrition and Health in Aging
- Analytical Methods in Pharmaceuticals
- Innovative Microfluidic and Catalytic Techniques Innovation
- Health and Well-being Studies
- Neuroscience of respiration and sleep
- Air Quality and Health Impacts
- Antibiotic Resistance in Bacteria
- Cardiovascular Syncope and Autonomic Disorders
- Gas Sensing Nanomaterials and Sensors
- Cardiac electrophysiology and arrhythmias
- Heart Failure Treatment and Management
- Vitamin D Research Studies
- Occupational exposure and asthma
AstraZeneca (United States)
2016-2021
AstraZeneca (Brazil)
2017-2021
AstraZeneca (Poland)
2018
Ark Therapeutic (United States)
2014-2017
Novartis (Switzerland)
2005-2006
Novartis (United Kingdom)
2006
Tris Pharma (United States)
2006
Novartis (United States)
2006
Research Triangle Park Foundation
2000-2003
GlaxoSmithKline (United States)
2003
Triple fixed-dose regimens of an inhaled glucocorticoid, a long-acting muscarinic antagonist (LAMA), and β2-agonist (LABA) for chronic obstructive pulmonary disease (COPD) have been studied at single dose levels but studies two are lacking.
Rationale: In the phase III, 52-week ETHOS (Efficacy and Safety of Triple Therapy in Obstructive Lung Disease) trial chronic obstructive pulmonary disease (COPD) (NCT02465567), triple therapy with budesonide/glycopyrrolate/formoterol fumarate (BGF) significantly reduced all-cause mortality compared glycopyrrolate/formoterol (GFF). However, 384 8,509 patients were missing vital status at Week 52 original analyses.Objectives: To assess robustness findings after additional data retrieval for...
Rationale: Moderate and severe exacerbations are incompletely prevented by maximal inhalation therapy in patients with chronic obstructive pulmonary disease.Objectives: To determine whether roflumilast reduces moderate and/or disease at risk for despite treatment inhaled corticosteroid/long-acting β2-agonist or without a long-acting muscarinic antagonist (LAMA).Methods: In this 52-week, phase 4, double-blind, placebo-controlled RE2SPOND (Roflumilast Effect on Exacerbations Patients Dual...
Abstract Background Ventilator-associated pneumonia caused by Pseudomonas aeruginosa (PA) in hospitalised patients is associated with high mortality. The effectiveness of the bivalent, bispecific mAb MEDI3902 (gremubamab) preventing PA nosocomial was assessed PA-colonised mechanically ventilated subjects. Methods EVADE (NCT02696902) a phase 2, randomised, parallel-group, double-blind, placebo-controlled study Europe, Turkey, Israel, and USA. Subjects ≥ 18 years old, ventilated, tracheally...
BackgroundThe long-term safety and efficacy of a novel Co-Suspension™ Delivery Technology glycopyrrolate (GP)/formoterol fumarate (FF) 18/9.6 μg fixed-dose combination metered dose inhaler (GFF MDI) were investigated in 28-week extension study (PINNACLE-3, NCT01970878) two randomized controlled Phase III trials (PINNACLE-1 -2; NCT01854645 NCT01854658) subjects with moderate-to-very severe chronic obstructive pulmonary disease (COPD).MethodsSubjects completing 24 weeks' treatment GFF MDI, GP...
Rationale: Roflumilast reduces exacerbations in patients with severe chronic obstructive pulmonary disease associated bronchitis and a history of exacerbations. Further characterization most likely to benefit is warranted.Objectives: Define characteristics that robustly identify who derive greatest exacerbation risk reduction roflumilast.Methods: Predefined, pooled analyses REACT (Roflumilast the Prevention COPD Exacerbations While Taking Appropriate Combination Treatment; NCT01329029)...
A randomized double-blind controlled trial of the effect vitamin D supplementation on abilities elderly hospital patients to carry out basic activities daily life is described. Those included in had plasma 25-hydroxyvitamin concentrations which were low or normal as judged by range young adults. After 2 9 months there was no significant difference performance control and treatment groups.
The purpose of this article is to document the discussions at 2010 European Workshop on Equivalence Determinations for Orally Inhaled Drugs Local Action, cohosted by International Society Aerosols in Medicine (ISAM) and Pharmaceutical Consortium Regulation Science (IPAC-RS). summarizes current regulatory approaches Europe, United States, Canada, presents points consensus as well ongoing debate four major areas: vitro testing, pharmacokinetic pharmacodynamic studies, device similarity....
Background: COPD is a major global cause of mortality and morbidity. PINNACLE-4 evaluated the efficacy safety GFF MDI (glycopyrrolate/formoterol fumarate metered dose inhaler) in patients from Asia, Europe, USA with moderate-to-very severe COPD. Methods: In this double-blind, placebo-controlled, Phase III study, were randomized to treatment 18/9.6 µg, glycopyrrolate (GP) 18 formoterol (FF) 9.6 or placebo (all twice daily) for 24 weeks. Lung function, patient-reported outcomes (symptoms...
<h3>Importance</h3> There is concern that long-acting muscarinic antagonists increase cardiovascular morbidity or mortality in patients with chronic obstructive pulmonary disease (COPD). <h3>Objective</h3> To determine the safety (noninferiority) and efficacy (superiority) of aclidinium bromide, 400 μg twice daily, COPD risk factors. <h3>Design, Setting, Participants</h3> Multicenter, randomized, placebo-controlled, double-blind, parallel-design study conducted at 522 sites North America. A...
Background: Patients with severe persistent asthma experience daily symptoms and frequent serious exacerbations that contribute to a significant impairment of health-related quality life (QoL).Methods: A pooled analysis was completed six controlled clinical trials evaluated the effect add-on omalizumab on asthma-related QoL in patients allergic (IgE-mediated) asthma. Asthma-related assessed at baseline treatment endpoint using well-validated Juniper Asthma Quality Life Questionnaire (AQLQ)....
A randomized study using functional respiratory imaging to characterize bronchodilator effects of glycopyrrolate/formoterol fumarate delivered by a metered dose inhaler co-suspension delivery technology in patients with COPD Wilfried De Backer,1 Jan Backer,2 Wim Vos,3 Ilse Verlinden,3 Cedric Van Holsbeke,3 Johan Clukers,1 Bita Hajian,1 Shahid Siddiqui,4 Martin Jenkins,5 Colin Reisner,4,6 Ubaldo J Martin4 1Department Respiratory Medicine, University Antwerp, Belgium; 2FLUIDDA, Los Angeles,...
Bronchodilator medications are central to the symptomatic management of chronic obstructive pulmonary disease (COPD). Metered-dose inhalers (MDIs) most commonly used devices deliver treatment patients with COPD and asthma, comprising approximately 70% bronchodilator prescriptions. Proprietary porous-particle technology permits formulation long-acting muscarinic antagonists, β2-agonists, a combination both in hydrofluoroalkane (HFA) MDIs, providing solution challenges inherent development HFA...