- Chronic Obstructive Pulmonary Disease (COPD) Research
- Asthma and respiratory diseases
- Respiratory Support and Mechanisms
- Inhalation and Respiratory Drug Delivery
- Pulmonary Hypertension Research and Treatments
- Respiratory and Cough-Related Research
- Respiratory viral infections research
- Influenza Virus Research Studies
- SARS-CoV-2 and COVID-19 Research
- Pharmacological Effects and Assays
- Viral gastroenteritis research and epidemiology
- Anesthesia and Sedative Agents
- COVID-19 epidemiological studies
- Heart Failure Treatment and Management
- COVID-19 Clinical Research Studies
- Intensive Care Unit Cognitive Disorders
- Biometric Identification and Security
- Privacy, Security, and Data Protection
- Insects and Parasite Interactions
- Pneumonia and Respiratory Infections
- Infectious Diseases and Mycology
- Pharmaceutical Practices and Patient Outcomes
- Space Exploration and Technology
- Sarcoidosis and Beryllium Toxicity Research
- Human-Automation Interaction and Safety
Baylor College of Medicine
2021
National Institutes of Health
2021
Brigham and Women's Hospital
2021
Kaiser Permanente
2021
University of Maryland, Baltimore
2021
University of Maryland, College Park
2021
Research Triangle Park Foundation
2019
Spartanburg Community College
2016-2019
University of South Carolina Upstate
2019
GlaxoSmithKline (United States)
2017
At interim analysis in a phase 3, observer-blinded, placebo-controlled clinical trial, the mRNA-1273 vaccine showed 94.1% efficacy preventing coronavirus disease 2019 (Covid-19). After emergency use of was authorized, protocol amended to include an open-label phase. Final analyses and safety data from blinded trial are reported.
We report the results of first direct comparison once-daily fixed-dose long-acting muscarinic antagonist/long-acting β2-agonist (LAMA/LABA) combinations umeclidinium/vilanterol (UMEC/VI) and tiotropium/olodaterol (TIO/OLO) in patients with COPD. This was a randomized, two-period crossover open-label study symptomatic COPD [age 40 years or older, postbronchodilator forced expiratory volume 1 s (FEV1) 70% less 50% more predicted normal values, modified Medical Research Council Dyspnoea Scale...
Indacaterol is a novel, once-daily (o.d.) inhaled, long-acting beta2-agonist in development for chronic obstructive pulmonary disease (COPD). This 12-week, double-blind study compared the efficacy, safety, and tolerability of indacaterol to that placebo patients with moderate-to-severe COPD.Efficacy variables included 24-h trough FEV1 (mean 23 h 10 min 45 post-dose) at Week 12 (primary endpoint) after Day 1, percentage COPD days poor control (i.e., worsening symptoms). Safety was assessed by...
Background: Olodaterol is a long-acting β 2 -agonist with 24-hour bronchodilator profile. Two replicate, randomized, double-blind, placebo-controlled, parallel-group, Phase III trials were performed as part of comprehensive clinical program to investigate the long-term safety and efficacy olodaterol in patients moderate very severe chronic obstructive pulmonary disease (COPD) receiving usual-care background therapy. Methods: Patients received 5 µg or 10 placebo once daily for 48 weeks....
Brief Reports15 May 1992Visceral Larva Migrans Associated with the Hypereosinophilic Syndrome and Onset of Severe AsthmaGregory J. Feldman, MD, H. Worth Parker, MDGregory MDAuthor, Article, Disclosure Informationhttps://doi.org/10.7326/0003-4819-116-10-838 SectionsAboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail ExcerptVisceral larva migrans, a syndrome various clinical manifestations, is infrequently recognized. In United...
Background: The long-acting muscarinic antagonists umeclidinium (UMEC) and tiotropium (TIO) are approved once-daily maintenance therapies for COPD. This study investigated the efficacy safety of UMEC versus TIO in Methods: was a 12-week, multicenter, randomized, blinded, double-dummy, parallel-group, non-inferiority study. Patients were randomized 1:1 to 62.5 µg plus placebo or 18 placebo. primary end point trough forced expiratory volume 1 second (FEV ) at day 85 (non-inferiority margin -50...
These studies evaluated the 24-h forced expiratory volume in 1 sec (FEV1) profile of once-daily (QD) olodaterol compared to placebo and twice-daily (BID) formoterol patients with moderate very severe chronic obstructive pulmonary disease. In two replicate, randomized, double-blind, double-dummy, four-way crossover studies, received 5 10 μg QD, 12 BID, or for 6 weeks addition usual-care background maintenance therapy. Co-primary end points were FEV1 area under curve from 0-12 h (AUC0-12)...
BackgroundFluticasone furoate/vilanterol (FF/VI) is an inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA), recently approved as once-daily maintenance therapy for COPD. We compared the lung function effects of FF/VI with those twice-daily fluticasone propionate/salmeterol (FP/SAL).MethodsThree 12 week studies comparing and FP/SAL were conducted. Patients aged ≥40 years moderate-to-very severe COPD randomized to receive double-blind, double-dummy 100/25 mcg once-daily, or 250/50...
Revefenacin, a novel, lung-selective, long-acting muscarinic antagonist, has been developed for nebulized therapy chronic obstructive pulmonary disease (COPD). We present the results of replicate Phase III efficacy and safety studies revefenacin in patients with moderate to very severe COPD.In 2 double-blind, parallel-group studies, (Study 0126 Study 0127), ≥ 40 years old were randomized 88 μg, 175 μg or placebo administered once daily by standard jet nebulizer 12 weeks. The primary endpoint...
Background Patient‐reported outcomes (PROs) are particularly relevant in influenza vaccine trials the elderly where reduction symptom severity could prevent illness‐related functional impairment. Objectives To evaluate PROs people aged ≥65 years receiving two different vaccines. Methods This was a phase III, randomised, observer‐blind study (NCT00753272) of AS03‐adjuvanted inactivated trivalent split‐virion (AS03‐TIV) versus non‐adjuvanted (TIV). Using FluiiQ questionnaire, (systemic,...
Efficacy and safety of twice-daily glycopyrrolate in patients with stable, symptomatic COPD moderate-to-severe airflow limitation: the GEM1 study Craig LaForce,1 Gregory Feldman,2 Selwyn Spangenthal,3 Joerg H Eckert,4 Michelle Henley,5 Francesco Patalano,4 Peter D'Andrea5 1North Carolina Clinical Research, Raleigh, NC, USA; 2South Pharmaceutical Spartanburg, SC, 3American Health Charlotte, 4Novartis Pharma AG, Basel, Switzerland; 5Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA...
Appropriate timing for dual bronchodilator therapy initiation in chronic obstructive pulmonary disease (COPD) management is uncertain. Combination recommended as step-up from monotherapy or first-line treatment patients with persistent symptoms. In this setting, umeclidinium/vilanterol (UMEC/VI) demonstrated improved lung function and reduced rescue medication use over tiotropium/olodaterol (TIO/OLO). This subgroup analysis explored efficacy differences between these combinations naïve to...
Symptoms of chronic obstructive pulmonary disease may vary throughout the day and it is important that therapeutic approaches provide 24-h symptom control. We report results two phase IIIb crossover studies, PT003011 PT003012, investigating lung function profile GFF MDI (glycopyrrolate/formoterol fumarate 18/9.6 μg delivered using innovative co-suspension delivery technology) administered twice daily. Patients with moderate-to-very severe received 4 weeks' treatment each MDI, placebo...