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3. Correlation of PROMIS scales and clinical measures among chronic obstructive pulmonary disease patients with and without exacerbations

Author

Irwin, Debra E, Atwood, Charles A, Hays, Ron D, Spritzer, Karen, Liu, Honghu, Donohue, James F, Leidy, Nancy Kline, Yount, Susan E, and DeWalt, Darren A

Subjects
Health Services and Systems, Health Sciences, Chronic Obstructive Pulmonary Disease, Behavioral and Social Science, Clinical Research, Lung, Health Services, Respiratory, Good Health and Well Being, Activities of Daily Living, Adult, Aged, Anxiety, Cross-Sectional Studies, Depression, Disease Progression, Fatigue, Female, Humans, Male, Middle Aged, Patient Outcome Assessment, Pulmonary Disease, Chronic Obstructive, Quality of Life, Self Report, Patient-reported outcomes, Health-related quality of life, Chronic obstructive pulmonary disease, Public Health and Health Services, Psychology, Health Policy & Services, Health sciences, Human society
Abstract

PurposeThe Patient-Reported Outcomes Measurement Information System (PROMIS(®)) initiative was developed to advance the methodology of PROs applicable to chronic diseases. Chronic obstructive pulmonary disease (COPD) is a progressive chronic disease associated with poor health. This study was designed to examine the correlation of PROMIS health-related quality of life (HRQOL) scales and clinical measures among COPD patients.MethodsA cross-sectional analysis was conducted comparing patients who were stable (n = 100) with those currently experiencing a COPD exacerbation (n = 85). All PROMIS measures for adults available at the time of the study (2008), disease-targeted and other HRQOL instruments, health literacy, percent predicted FEV1, and a 6-min walk distance were assessed when patients were considered clinically stable.ResultsStable COPD patients reported significantly (p ≤ 0.05) better health-related quality of life on PROMIS domains than patients experiencing an exacerbation. PROMIS domain scores were significantly (p ≤ 0.01) correlated with each of legacy measures. Six-min walk scores were most highly correlated with the PROMIS physical function domain scores (r = 0.53) followed by the fatigue (r = -0.26), social (r = 0.24) and to a lesser extent depression (r = -0.23), and anxiety (r = -0.22) domain scores. Percent predicted FEV1 score was significantly associated with PROMIS physical function scores (r = 0.27).ConclusionThis study provides support for the validity of the PROMIS measures in COPD patients.

Published
2015

9. Bridging the “Know-Do” Gaps in Five Non-Communicable Diseases Using a Common Framework Driven by Implementation Science

Author

Donohue, James F, primary, Elborn, J Stuart, additional, Lansberg, Peter, additional, Javed, Afzal, additional, Tesfaye, Solomon, additional, Rugo, Hope, additional, Duddi, Sita Ratna Devi, additional, Jithoo, Niraksha, additional, Huang, Pai-Hui, additional, Subramaniam, Kannan, additional, Ramanjinappa, Nagendra, additional, Koltun, Arkady, additional, Melamed, Shari, additional, and Chan, Juliana CN, additional

Published
2023
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17. Bridging the “Know-Do” Gaps in Five Non-Communicable Diseases Using a Common Framework Driven by Implementation Science

Author

Donohue,James F, Elborn,J Stuart, Lansberg,Peter, Javed,Afzal, Tesfaye,Solomon, Rugo,Hope, Duddi,Sita Ratna Devi, Jithoo,Niraksha, Huang,Pai-Hui, Subramaniam,Kannan, Ramanjinappa,Nagendra, Koltun,Arkady, Melamed,Shari, Chan,Juliana CN, Donohue,James F, Elborn,J Stuart, Lansberg,Peter, Javed,Afzal, Tesfaye,Solomon, Rugo,Hope, Duddi,Sita Ratna Devi, Jithoo,Niraksha, Huang,Pai-Hui, Subramaniam,Kannan, Ramanjinappa,Nagendra, Koltun,Arkady, Melamed,Shari, and Chan,Juliana CN

Abstract

James F Donohue,1 J Stuart Elborn,2 Peter Lansberg,3 Afzal Javed,4 Solomon Tesfaye,5 Hope Rugo,6 Sita Ratna Devi Duddi,7,8 Niraksha Jithoo,9 Pai-Hui Huang,10 Kannan Subramaniam,11 Nagendra Ramanjinappa,12 Arkady Koltun,13 Shari Melamed,13 Juliana CN Chan14 1UNC School of Medicine, Chapel Hill, NC, USA; 2Queen’s University, Belfast, UK; 3University Medical Center, Groningen, the Netherlands; 4Warwick Medical School, University of Warwick, Warwick, UK & Pakistan Psychiatric Research Centre, Coventry, UK; 5Sheffield Teaching Hospitals and the University of Sheffield, Sheffield, UK; 6University of California San Francisco Comprehensive Cancer Center, San Francisco, CA, USA; 7International Alliance of Patients’ Organisations, London, United Kingdom; 8DakshamA Health and Education, Delhi, India; 9Viatris Ltd, Johannesburg, South Africa; 10Viatris Pharmaceutical Co., Ltd, Taipei, Taiwan; 11Viatris Ltd, Auckland, New Zealand; 12Viatris Ltd, Bangalore, India; 13Viatris Ltd, Canonsburg, PA, USA; 14Department of Medicine and Therapeutics, Hong Kong Institute of Diabetes and Obesity, Li Ka Shing Institute of Health Sciences, The Chinese University of Hong Kong, Prince of Wales Hospital, Hong Kong, Special Administrative Regions of the People’s Republic of ChinaCorrespondence: Juliana CN Chan, Department of Medicine and Therapeutics, Hong Kong Institute of Diabetes and Obesity, Li Ka Shing Institute of Health Sciences, The Chinese University of Hong Kong, Prince of Wales Hospital, Hong Kong, Special Administrative Regions of the People’s Republic of China, Tel +852 3505 3138, Email jchan@cuhk.edu.hkAbstract: According to the United Nations High-Level Meeting 2018, five non-communicable diseases (NCDs) including cardiovascular diseases, chronic respiratory diseases, diabetes mellitus, cancer, and mental health conditions accounted for two-thirds of global deaths. These five NCDs share five common risk factors including tobacco use

Published
2023

18. Ensifentrine as a Novel, Inhaled Treatment for Patients with COPD

Author

Donohue,James F, Rheault,Tara, MacDonald-Berko,Margot, Bengtsson,Thomas, Rickard,Kathleen, Donohue,James F, Rheault,Tara, MacDonald-Berko,Margot, Bengtsson,Thomas, and Rickard,Kathleen

Abstract

James F Donohue,1 Tara Rheault,2 Margot MacDonald-Berko,2 Thomas Bengtsson,3 Kathleen Rickard2 1Division of Pulmonary and Critical Care Medicine, University of North Carolina, School of Medicine, Chapel Hill, NC, USA; 2Verona Pharma plc, Raleigh, NC, USA; 3Stat Mind AB, Lund, SwedenCorrespondence: Tara Rheault, Verona Pharma, 8045 Arco Corporate Drive, Suite 130, Raleigh, NC, 27617, USA, Tel +1 646-530-2126, Email tara.rheault@veronapharma.comAbstract: Ensifentrine is a novel, potent, and selective dual inhibitor of phosphodiesterase (PDE)3 and PDE4 designed for delivery by inhalation that combines effects on airway inflammation, bronchodilation and ciliary function in bronchial epithelia. In Phase 2 studies in subjects with COPD, ensifentrine demonstrated clinically meaningful bronchodilation and improvements in symptoms and health-related quality of life when administered alone or in combination with current standard of care therapies. Ensifentrine is currently in late-stage clinical development for the maintenance treatment of patients with COPD. This review summarizes non-clinical data as well as Phase 1 and Phase 2 efficacy and safety results of nebulized ensifentrine relevant to the maintenance treatment of patients with COPD.Keywords: RPL554, nebulized therapy, chronic obstructive pulmonary disease, clinical efficacy, drug development

Published
2023

19. A multicenter, randomized, double-blind dose-ranging study of glycopyrrolate/formoterol fumarate fixed-dose combination metered dose inhaler compared to the monocomponents and open-label tiotropium dry powder inhaler in patients with moderate-to-severe COPD

Author

Tashkin, Donald P., Martinez, Fernando J., Rodriguez-Roisin, Roberto, Fogarty, Charles, Gotfried, Mark, Denenberg, Michael, Gottschlich, Gregory, Donohue, James F., Orevillo, Chad, Darken, Patrick, St Rose, Earl, Strom, Shannon, Fischer, Tracy, Golden, Michael, and Reisner, Colin

Published
2016
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30. Current Perspectives of Pharmacotherapies for COPD.

Author

Pleasants, Roy A. and Donohue, James F.

Subjects
HEART disease complications, NITRIC oxide analysis, BIOTHERAPY, BIOMARKERS, DRUG efficacy, EOSINOPHILS, GLUCOCORTICOIDS, ADRENOCORTICAL hormones, ASTHMA, DIGITAL technology, INDIVIDUALIZED medicine, INVESTIGATIONAL drugs, CELL receptors, BRONCHODILATOR agents, OBSTRUCTIVE lung diseases, ALPHA 1-antitrypsin deficiency, INHALATION administration, COMORBIDITY, PHENOTYPES, PATIENT safety, PHOSPHODIESTERASE inhibitors, DISEASE complications
Abstract

Pharmacotherapies and avoidance of environmental/inhaled toxins are core to managing COPD. Compared to the drugs available 50 years ago, there has been substantial progress with COPD pharmacotherapies, but gaps in adherence and inhaler use persist. Personalizing inhaled pharmacotherapies is now possible with digital technologies by objectively documenting adherence and guiding inhaler technique. Another means to improve existing pharmacotherapies is through phenotyping and biomarkers. This is especially important considering the heterogeneity of the disease COPD. Blood eosinophils are now a recommended biomarker to guide use of inhaled corticosteroids and biologics in COPD. On the near horizon, we will see new inhaled medications as dual phosphodiesterase inhibitors, drugs to treat basic protein abnormalities as in alpha-1 antitrypsin deficiency that could have remarkable benefits, and biologic drugs targeting specific cell/mediator types in the COPD population. Characterization of COPD phenotypes, as asthma/COPD overlap and comorbid heart disease are vital to understand how to optimize pharmacotherapies. Importantly, we must determine how to optimize current medications; otherwise, we will repeat the same mistakes with new medications. But as we know so well, as we peel one layer of complexity, we encounter many more questions, all the while dedicated to limiting the burden of COPD. [ABSTRACT FROM AUTHOR]

Published
2023
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38. Respiratory Symptoms Among US Adults

Author

Pleasants, Roy Alton, primary, Heidari, Khosrow, additional, Donohue, James F., additional, Ohar, Jill, additional, Lugogo, Njira, additional, Kanotra, Sarojini, additional, Kraft, Monica, additional, Mannino, David, additional, and Strange, Charlie, additional

Published
2022
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41. Revefenacin: A Once-Daily, Long-Acting Bronchodilator For Nebulized Treatment Of COPD

Author

Donohue, James F, Mahler, Donald A, and Sethi, Sanjay

Subjects
bronchodilator, Nebulizers and Vaporizers, LAMA, nebulizer, Review, Muscarinic Antagonists, once daily, Bronchodilator Agents, Pulmonary Disease, Chronic Obstructive, Treatment Outcome, Delayed-Action Preparations, Benzamides, long-acting muscarinic antagonist, inhaled, Humans, Carbamates
Abstract

Bronchodilation with muscarinic antagonists, β2-agonists, and inhaled corticosteroids remains the foundation of pharmaceutical treatment for patients with stable COPD. These drugs are delivered from a variety of devices, including dry powder inhalers, pressurized metered-dose inhalers, soft-mist inhalers, or nebulizers. Nebulized delivery is often preferable in patients who are elderly, are cognitively impaired, are unable to generate sufficient inspiratory force to use their inhaler, have difficulty coordinating hand-breath activity, are too dyspneic to hold their breath for a sufficient time, and/or may be acutely ill. Revefenacin, a once-daily long-acting muscarinic antagonist for nebulization recently approved by the US FDA for the treatment of patients with COPD, was discovered and developed using “duration and lung selectivity-by-design.” This strategy selected a molecule with a high lung-selective index to maximize bronchodilation and limit systemic anti-muscarinic side effects. In early-phase clinical studies, revefenacin for nebulization led to a rapid onset of bronchodilation that was sustained for 24 hrs in patients with moderate to severe COPD. Revefenacin also demonstrated minimal systemic exposure and good tolerability in these studies. Statistically and clinically significant improvements in lung function (ie, peak and/or trough FEV1) relative to placebo were observed with revefenacin in Phase III clinical trials of up to 3 months in patients with moderate to very severe COPD. Revefenacin was well tolerated in Phase III clinical trials with a low incidence of systemic antimuscarinic adverse events, which is consistent with its lung-selective design. There was no evidence of an increased risk of major cardiovascular events. Patient-reported outcome data from clinical trials indicated statistically significant improvements in several disease-specific measures. Revefenacin 175 μg for nebulization provides an effective once-daily treatment option for patients with moderate to very severe COPD who require or prefer nebulized therapy.

Published
2019

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