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Article: Clinical Trial Design Innovations for Precision Medicine in Asthma.

Siddiqui, Salman / Haf Davies, Elin / Afshar, Majid / Denlinger, Loren C

Advances in experimental medicine and biology

2023 Volume 1426, Page(s) 395–412

Abstract: Severe asthma is a spectrum disorder with numerous subsets, many of which are defined by clinical history and a general predisposition for T2 inflammation. Most of the approved therapies for severe asthma have required clinical trial designs with ... ...

Abstract	Severe asthma is a spectrum disorder with numerous subsets, many of which are defined by clinical history and a general predisposition for T2 inflammation. Most of the approved therapies for severe asthma have required clinical trial designs with population enrichment for exacerbation frequency and/or elevation of blood eosinophils. Moving beyond this framework will require trial designs that increase efficiency for studying nondominant subsets and continue to improve upon biomarker signatures. In addition to reviewing the current literature on biomarker-informed trials for severe asthma, this chapter will also review the advantages of master protocols and adaptive design methods for establishing the efficacy of new interventions in prospectively defined subsets of patients. The incorporation of methods that allow for data collection outside of traditional study visits at academic centers, called remote decentralized trial design, is a growing trend that may increase diversity in study participation and allow for enhanced resiliency during the COVID-19 pandemic. Finally, reaching the goals of precision medicine in asthma will require increased emphasis on effectiveness studies. Recent advances in real-world data utilization from electronic health records are also discussed with a view toward pragmatic trial designs that could also incorporate the evaluation of biomarker signatures.
MeSH term(s)	Humans ; Asthma/diagnosis ; Asthma/therapy ; Biomarkers ; Clinical Trials as Topic ; COVID-19/therapy ; Pandemics ; Precision Medicine
Chemical Substances	Biomarkers
Language	English
Publishing date	2023-07-17
Publishing country	United States
Document type	Journal Article
ZDB-ID	410187-X
ISSN	0065-2598
ISSN	0065-2598
DOI	10.1007/978-3-031-32259-4_17
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Article ; Online: P2X

Townsend, Elizabeth A / Guadarrama, Arturo / Shi, Lei / Roti Roti, Elon / Denlinger, Loren C

American journal of physiology. Lung cellular and molecular physiology

2023 Volume 325, Issue 4, Page(s) L399–L410

Abstract: Few new therapeutics exist to target airway inflammation in mild-to-moderate asthma. Alveolar macrophages regulate airway inflammation by producing proresolving eicosanoids. We hypothesized that stimulation of the purinergic receptor ... ...

Abstract	Few new therapeutics exist to target airway inflammation in mild-to-moderate asthma. Alveolar macrophages regulate airway inflammation by producing proresolving eicosanoids. We hypothesized that stimulation of the purinergic receptor P2X
MeSH term(s)	Humans ; Macrophages, Alveolar/metabolism ; Asthma ; Eicosanoids/metabolism ; Inflammation ; Hydroxyeicosatetraenoic Acids
Chemical Substances	AZD9056 ; Eicosanoids ; Hydroxyeicosatetraenoic Acids
Language	English
Publishing date	2023-08-15
Publishing country	United States
Document type	Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
ZDB-ID	1013184-x
ISSN	1522-1504 ; 1040-0605
ISSN (online)	1522-1504
ISSN	1040-0605
DOI	10.1152/ajplung.00070.2023
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Article ; Online: Reply to Nannini and to Lipworth

Peters, Michael C / Fahy, John V / Denlinger, Loren C

American journal of respiratory and critical care medicine

2020 Volume 202, Issue 9, Page(s) 1325–1326

MeSH term(s)	Asthma ; Biomarkers ; Humans
Chemical Substances	Biomarkers
Keywords	covid19
Language	English
Publishing date	2020-08-17
Publishing country	United States
Document type	Letter ; Comment
ZDB-ID	1180953-x
ISSN	1535-4970 ; 0003-0805 ; 1073-449X
ISSN (online)	1535-4970
ISSN	0003-0805 ; 1073-449X
DOI	10.1164/rccm.202006-2531LE
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Article ; Online: COVID-19 Infections and Asthma.

Palmon, Philip A / Jackson, Daniel J / Denlinger, Loren C

The journal of allergy and clinical immunology. In practice

2021 Volume 10, Issue 3, Page(s) 658–663

Abstract: The severe acute respiratory syndrome coronavirus 2, which causes coronavirus disease 2019 (COVID-19), has infected more than 200 million and led to the deaths of more than 4.3 million people. Although there are known risk factors for severe disease, ... ...

Abstract	The severe acute respiratory syndrome coronavirus 2, which causes coronavirus disease 2019 (COVID-19), has infected more than 200 million and led to the deaths of more than 4.3 million people. Although there are known risk factors for severe disease, asthma was initially hypothesized to be a risk factor for severe disease given the association between asthma exacerbations and respiratory viral illnesses in general. Fortunately, clinical outcomes for patients with asthma overall are similar to those for patients without asthma, without convincing evidence that asthma is a risk factor for severe disease. This may be explained in part by the decreasing gradient of angiotensin-converting enzyme-2 receptor from the upper to lower respiratory epithelium and that aeroallergen-sensitized patients with asthma can have up to 50% reduction in angiotensin-converting enzyme-2 receptor expression. Vaccination for patients with asthma is recommended for all without clear contraindications. COVID-19-specific treatment options are available depending on the severity of disease. We caution the use of systemic corticosteroids in patients with asthma not requiring supplemental oxygen given an association with worse outcomes. Postacute COVID-19 syndrome or long-haul COVID does not appear to be more prevalent in the population with asthma, and a multidisciplinary approach to care is a reasonable option.
MeSH term(s)	Asthma/drug therapy ; Asthma/epidemiology ; COVID-19/complications ; COVID-19/epidemiology ; Humans ; Risk Factors ; SARS-CoV-2
Language	English
Publishing date	2021-11-25
Publishing country	United States
Document type	Journal Article
ZDB-ID	2843237-X
ISSN	2213-2201 ; 2213-2198
ISSN (online)	2213-2201
ISSN	2213-2198
DOI	10.1016/j.jaip.2021.10.072
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Article: Comparison of hyperpolarized

Carey, Katherine J / Hotvedt, Peter / Mummy, David G / Lee, Kristine E / Denlinger, Loren C / Schiebler, Mark L / Sorkness, Ronald L / Jarjour, Nizar N / Hatt, Charles R / Galban, Craig J / Fain, Sean B

Frontiers in physiology

2023 Volume 14, Page(s) 1178339

Abstract: Purpose: ...

Abstract	Purpose:
Language	English
Publishing date	2023-08-01
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2564217-0
ISSN	1664-042X
ISSN	1664-042X
DOI	10.3389/fphys.2023.1178339
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Article ; Online: Protein-Protein interactive networks identified in bronchoalveolar lavage of severe compared to nonsevere asthma.

Hastie, Annette T / Bishop, Andrew C / Khan, Mohammad S / Bleecker, Eugene R / Castro, Mario / Denlinger, Loren C / Erzurum, Serpil C / Fahy, John V / Israel, Elliot / Levy, Bruce D / Mauger, David T / Meyers, Deborah A / Moore, Wendy C / Ortega, Victor E / Peters, Stephen P / Wenzel, Sally E / Steele, Chad H

Clinical and experimental allergy : journal of the British Society for Allergy and Clinical Immunology

2024 Volume 54, Issue 4, Page(s) 265–277

Abstract: Introduction: Previous bronchoalveolar lavage fluid (BALF) proteomic analysis has evaluated limited numbers of subjects for only a few proteins of interest, which may differ between asthma and normal controls. Our objective was to examine a more ... ...

Abstract	Introduction: Previous bronchoalveolar lavage fluid (BALF) proteomic analysis has evaluated limited numbers of subjects for only a few proteins of interest, which may differ between asthma and normal controls. Our objective was to examine a more comprehensive inflammatory biomarker panel in quantitative proteomic analysis for a large asthma cohort to identify molecular phenotypes distinguishing severe from nonsevere asthma. Methods: Bronchoalveolar lavage fluid from 48 severe and 77 nonsevere adult asthma subjects were assessed for 75 inflammatory proteins, normalized to BALF total protein concentration. Validation of BALF differences was sought through equivalent protein analysis of autologous sputum. Subjects' data, stratified by asthma severity, were analysed by standard statistical tests, principal component analysis and 5 machine learning algorithms. Results: The severe group had lower lung function and greater health care utilization. Significantly increased BALF proteins for severe asthma compared to nonsevere asthma were fibroblast growth factor 2 (FGF2), TGFα, IL1Ra, IL2, IL4, CCL8, CCL13 and CXCL7 and significantly decreased were platelet-derived growth factor a-a dimer (PDGFaa), vascular endothelial growth factor (VEGF), interleukin 5 (IL5), CCL17, CCL22, CXCL9 and CXCL10. Four protein differences were replicated in sputum. FGF2, PDGFaa and CXCL7 were independently identified by 5 machine learning algorithms as the most important variables for discriminating severe and nonsevere asthma. Increased and decreased proteins identified for the severe cluster showed significant protein-protein interactions for chemokine and cytokine signalling, growth factor activity, and eosinophil and neutrophil chemotaxis differing between subjects with severe and nonsevere asthma. Conclusion: These inflammatory protein results confirm altered airway remodelling and cytokine/chemokine activity recruiting leukocytes into the airways of severe compared to nonsevere asthma as important processes even in stable status.
MeSH term(s)	Adult ; Humans ; Vascular Endothelial Growth Factor A ; Proteomics ; Fibroblast Growth Factor 2 ; Asthma ; Cytokines/metabolism ; Bronchoalveolar Lavage ; Chemokines ; Bronchoalveolar Lavage Fluid
Chemical Substances	Vascular Endothelial Growth Factor A ; Fibroblast Growth Factor 2 (103107-01-3) ; Cytokines ; Chemokines
Language	English
Publishing date	2024-01-22
Publishing country	England
Document type	Journal Article
ZDB-ID	645204-8
ISSN	1365-2222 ; 0954-7894 ; 0960-2178
ISSN (online)	1365-2222
ISSN	0954-7894 ; 0960-2178
DOI	10.1111/cea.14447
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Article ; Online: Exacerbation-Prone Asthma: A Biological Phenotype or a Social Construct.

Federico, Monica J / Denlinger, Loren C / Corren, Jonathan / Szefler, Stanley J / Fuhlbrigge, Anne L

The journal of allergy and clinical immunology. In practice

2021 Volume 9, Issue 7, Page(s) 2627–2634

Abstract: Asthma is a complex syndrome with multiple phenotypes and endotypes. Asthma exacerbations are not only the clearest indictor of the morbidity of asthma and of the risk for mortality due to asthma, but also comprise a significant amount of the cost to ... ...

Abstract	Asthma is a complex syndrome with multiple phenotypes and endotypes. Asthma exacerbations are not only the clearest indictor of the morbidity of asthma and of the risk for mortality due to asthma, but also comprise a significant amount of the cost to care for poorly controlled asthma. There continues to be significant disparity in the prevalence, mortality, and morbidity due to asthma. Patients with asthma who suffer recurrent exacerbations are considered to have exacerbation-prone asthma (EPA). Efforts to characterize patients with frequent exacerbations show that the etiology is likely multifactorial. Research to determine the intrinsic risk factors for EPA include studies of both genetic and inflammatory biomarkers. External factors contributing to exacerbations have been extensively reviewed and include viral infection, environmental exposures, air pollution, and psychosocial and economic barriers to optimizing health. It is likely that EPA occurs when patients who have an increased underlying intrinsic/biological risk are placed in a given exposome (environments with a variety of exposures and triggers including allergens, pollution, stress, barriers, and occupational exposures). It is the social construct combined with underlying biology that frequently drives an EPA phenotype.
MeSH term(s)	Allergens ; Asthma/epidemiology ; Biomarkers ; Humans ; Phenotype ; Virus Diseases
Chemical Substances	Allergens ; Biomarkers
Language	English
Publishing date	2021-05-26
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2843237-X
ISSN	2213-2201 ; 2213-2198
ISSN (online)	2213-2201
ISSN	2213-2198
DOI	10.1016/j.jaip.2021.05.011
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Article ; Online: Ensemble Analysis Identifies Nasal 15-Keto-PGE2 as a Predictor of Recovery in Experimental Rhinovirus Colds.

Lane Starr, Nicole M / Evans, Michael D / Lee, Kristine E / Gern, James E / Denlinger, Loren C

The Journal of infectious diseases

2021 Volume 224, Issue 5, Page(s) 839–849

Abstract: Background: Symptom intensity during a common cold is highly variable, particularly after the illness peaks, contributing to delay in recovery. Rhinoviruses frequently cause colds and, during acute infections, generate leukotriene B4 and prostaglandin ... ...

Abstract	Background: Symptom intensity during a common cold is highly variable, particularly after the illness peaks, contributing to delay in recovery. Rhinoviruses frequently cause colds and, during acute infections, generate leukotriene B4 and prostaglandin E2 (PGE2). PGE2 is known to initiate oxylipin class switching and resolution of acute inflammation. Thus, we hypothesized that during acute rhinovirus colds, oxylipins with pro-resolving capabilities reduce symptom severity and speed recovery. Methods: Four groups of healthy volunteers were inoculated with placebo or 3 different doses of rhinovirus A16. Participants kept daily records of symptoms and contributed serial nasal lavage fluid samples. We collected semi-quantitative mass spectrometry data for 71 oxylipins in these acute samples from all participants. An ensemble analysis approach was used to further reduce this dataset. Results: Levels of 15-keto-PGE2 at day 3 of the cold were consistently among the top candidates in these models of recovery symptoms. 15-keto-PGE2 was the only oxylipin with an interaction between inoculum dose and time. Acute 15-keto-PGE2 levels were inversely associated with symptoms during cold recovery in a multivariable analysis (P = .0043). Conclusions: These findings show that high 15-keto-PGE2 levels during the acute cold are associated with fewer symptoms during recovery.
MeSH term(s)	Adult ; Common Cold/immunology ; Common Cold/virology ; Dinoprostone/analogs & derivatives ; Dinoprostone/metabolism ; Female ; Humans ; Male ; Mass Spectrometry ; Nasal Lavage Fluid ; Oxylipins/metabolism ; Prognosis ; Rhinovirus/immunology
Chemical Substances	Oxylipins ; 15-ketoprostaglandin E2 (2S0F1FTK13) ; Dinoprostone (K7Q1JQR04M)
Language	English
Publishing date	2021-03-07
Publishing country	United States
Document type	Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
ZDB-ID	3019-3
ISSN	1537-6613 ; 0022-1899
ISSN (online)	1537-6613
ISSN	0022-1899
DOI	10.1093/infdis/jiab015
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Article: Reply to Nannini and to Lipworth et al

Peters, Michael C. / Fahy, John V. / Denlinger, Loren C.

American Journal of Respiratory and Critical Care Medicine

Abstract: Peters et al reply to Nannini and to Lipworth et al Dr Nannini is concerned that IL-6 could be upregulated by overuse of β2-agonists This is unlikely because the SARP-III (Severe Asthma Research Program III) protocol included a bronchodilator medication ... ...

Abstract	Peters et al reply to Nannini and to Lipworth et al Dr Nannini is concerned that IL-6 could be upregulated by overuse of β2-agonists This is unlikely because the SARP-III (Severe Asthma Research Program III) protocol included a bronchodilator medication hold for the blood collection visits Lipworth et al provide important commentary on the links between IL-6 biology and airway viral infections, including coronavirus disease (COVID-19)
Keywords	covid19
Publisher	WHO
Document type	Article
Note	WHO #Covidence: #910495
Database	COVID19

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Article ; Online: Exacerbation-Prone Asthma.

Denlinger, Loren C / Heymann, Peter / Lutter, Rene / Gern, James E

The journal of allergy and clinical immunology. In practice

2019 Volume 8, Issue 2, Page(s) 474–482

Abstract: Patients who are prone to exacerbations of asthma experience significant costs in terms of missed work and school, acute care visits, and hospitalizations. Exacerbations are largely driven by environmental exposures including pollutants, stress, and ... ...

Abstract	Patients who are prone to exacerbations of asthma experience significant costs in terms of missed work and school, acute care visits, and hospitalizations. Exacerbations are largely driven by environmental exposures including pollutants, stress, and viral and bacterial pathogens. These exposures are most likely to induce acute severe "asthma attacks" in high-risk patients. These personal risk factors for exacerbations can vary with the phenotype of asthma and age of the patient. In children, allergic sensitization is a strong risk factor, especially for those children who develop sensitization early in life. Airway inflammation is an important risk factor, and biomarkers are under evaluation for utility in detecting eosinophilic and type 2 inflammation and neutrophilic inflammation as indicators of risk for recurrent exacerbations. Insights into inflammatory mechanisms have led to new approaches to prevent exacerbations using mAb-based biologics that target specific type 2 pathways. Challenges remain in developing an evidence base to support precision interventions with these effective yet expensive therapies, and in determining whether these treatments will be safe and effective in young children. Unfortunately, there has been less progress in developing treatments for acute exacerbations. Hopefully, greater understanding of mechanisms relating airway viruses, bacteria, mucin production, and neutrophilic inflammatory responses will lead to additional treatment options for patients experiencing acute exacerbations.
MeSH term(s)	Adult ; Allergens ; Asthma/diagnosis ; Asthma/epidemiology ; Asthma/therapy ; Child ; Child, Preschool ; Disease Progression ; Humans ; Hypersensitivity ; Inflammation ; Respiratory Sounds ; Young Adult
Chemical Substances	Allergens
Language	English
Publishing date	2019-11-22
Publishing country	United States
Document type	Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
ZDB-ID	2843237-X
ISSN	2213-2201 ; 2213-2198
ISSN (online)	2213-2201
ISSN	2213-2198
DOI	10.1016/j.jaip.2019.11.009
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