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Cross-sectional study to characterize cohorts of subjects with asthma and healthy controls in terms of clinical features, physiological measurements and non-invasive measurement of biomarkers and develop phenotype handprints for adults with severe asthma
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A | Adults: severe asthmatics on high dose ICS and / or OCS | ||
| Cohort B | Adults: current smokers or ex-smokers, severe asthmatics on high dose ICS and / or OCS | ||
| Cohort C | Adults: non-smokers, mild to moderate asthmatics on regular inhaled corticosteroids (ICS) | ||
| Cohort D | Adults: healthy volunteers, non-smokers, non-asthmatic with pre bronchodilator FEV1 > 80% predicted |
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| Measure | Description | Time Frame |
|---|---|---|
| Asthma exacerbations | Number, duration and severity of exacerbations over the time of the study | 3 years |
| Lung function decline over the course of the study | 3 years | |
| Changes in asthma medication | in particular ICS dose, over the duration of the study | 3 years |
| Daily symptoms and short acting beta agonist (SABA) usage | measured during the telemonitoring study | 3 years |
| Asthma control questionnaire (ACQ) at baseline and changes over the course of the study | 3 years | |
| Upper airway symptoms as assessed by the sino-nasal outcomes test (SNOT) at baseline and changes over the course of the study | 3 years | |
| Sleep and daytime drowsiness as assessed by the Epworth sleepiness scale at baseline and changes over the course of the study | 3 years | |
| Measurement of pulmonary function including spirometry, plethysmography, bronchodilator reversibility and respiratory impedance by forced oscillation technique | 3 years | |
| Radiological parameters such as computerized tomography (CT) scan, including assessment of lung structure |
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General Inclusion Criteria:
General Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter Sterk, Dr. | Academic Medical Centre University of Amsterdam, The Netherlands | Principal Investigator |
| Ratko Djukanovic, Dr. | Southampton General Hospital, UK | Principal Investigator |
| Stephen Fowler, Dr. | Respiratory Research Group, Education and Research Centre, Wythenshawe Hospital, UK | Principal Investigator |
| Kian Fan Chung, Dr. | Imperial College London, UK | Principal Investigator |
| Barbro Dahlén, Dr. | Karolinska Institutet | Principal Investigator |
| Andrew Szczeklik, Dr. | Uniwersytet Jagielloński - Collegium Medicum, Kraków, Poland | Principal Investigator |
| Thomas Geiser, Dr. | Inselspital and University of Bern, Switzerland | Principal Investigator |
| Ildiko Horvath, Dr. | University School of Medicine, Budapest, Hundary | Principal Investigator |
| Pascal Chanez, Dr. | Université de la Méditerranee, Marseille, France |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34824054 | Derived | Reinke SN, Naz S, Chaleckis R, Gallart-Ayala H, Kolmert J, Kermani NZ, Tiotiu A, Broadhurst DI, Lundqvist A, Olsson H, Strom M, Wheelock AM, Gomez C, Ericsson M, Sousa AR, Riley JH, Bates S, Scholfield J, Loza M, Baribaud F, Bakke PS, Caruso M, Chanez P, Fowler SJ, Geiser T, Howarth P, Horvath I, Krug N, Montuschi P, Behndig A, Singer F, Musial J, Shaw DE, Dahlen B, Hu S, Lasky-Su J, Sterk PJ, Chung KF, Djukanovic R, Dahlen SE, Adcock IM, Wheelock CE; U-BIOPRED Study Group. Urinary metabotype of severe asthma evidences decreased carnitine metabolism independent of oral corticosteroid treatment in the U-BIOPRED study. Eur Respir J. 2022 Jun 30;59(6):2101733. doi: 10.1183/13993003.01733-2021. Print 2022 Jun. | |
| 32667261 |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| 3 years |
| Measurement of inflammatory cell counts in blood, sputum and bronchoalveolar lavage (BAL) | 3 years |
| Histopathology of bronchial biopsies in a sub group of subjects | immunohistochemistry for inflammatory cells and matrix remodelling | 3 years |
| Transcriptomics, proteomics and metabolomics will be used on samples such as blood, urine and endobronchial biopsies | to develop clinically useful phenotype handprints | 3 years |
| Quality of life as assessed by the asthma quality of life questionnaire (AQLQ) | 3 years |
| Anxiety and depression as assessed by the hospital anxiety and depression scale (HADS) | 3 years |
| Principal Investigator |
| Jens Hohlfeld, Dr. | Fraunhofer Institute for Toxicology and Experimental Medicine, Hannover | Principal Investigator |
| Thomas Sandström, Dr. | Department of Public Health and Clinical Medicine, Division of Medicine, Umea, Sweden | Principal Investigator |
| Dominick Shaw, Dr. | Nottingham City Hospita, Nottingham, UK | Principal Investigator |
| Per Sigvald Bakke, Dr. | Haukeland University Hospital, Bergen, Norway | Principal Investigator |
| Riccardo Polosa, Dr. | Policlinico Vittorio Emmanuele, Catania, Italy | Principal Investigator |
| Paolo Montuschi, Dr. | Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Principal Investigator |
| Derived |
| Kolmert J, Gomez C, Balgoma D, Sjodin M, Bood J, Konradsen JR, Ericsson M, Thorngren JO, James A, Mikus M, Sousa AR, Riley JH, Bates S, Bakke PS, Pandis I, Caruso M, Chanez P, Fowler SJ, Geiser T, Howarth P, Horvath I, Krug N, Montuschi P, Sanak M, Behndig A, Shaw DE, Knowles RG, Holweg CTJ, Wheelock AM, Dahlen B, Nordlund B, Alving K, Hedlin G, Chung KF, Adcock IM, Sterk PJ, Djukanovic R, Dahlen SE, Wheelock CE; U-BIOPRED Study Group, on behalf of the U-BIOPRED Study Group. Urinary Leukotriene E4 and Prostaglandin D2 Metabolites Increase in Adult and Childhood Severe Asthma Characterized by Type 2 Inflammation. A Clinical Observational Study. Am J Respir Crit Care Med. 2021 Jan 1;203(1):37-53. doi: 10.1164/rccm.201909-1869OC. |
| 30240401 | Derived | Emma R, Bansal AT, Kolmert J, Wheelock CE, Dahlen SE, Loza MJ, De Meulder B, Lefaudeux D, Auffray C, Dahlen B, Bakke PS, Chanez P, Fowler SJ, Horvath I, Montuschi P, Krug N, Sanak M, Sandstrom T, Shaw DE, Fleming LJ, Djukanovic R, Howarth PH, Singer F, Sousa AR, Sterk PJ, Corfield J, Pandis I, Chung KF, Adcock IM, Lutter R, Fabbella L, Caruso M; U-BIOPRED Study Group. Enhanced oxidative stress in smoking and ex-smoking severe asthma in the U-BIOPRED cohort. PLoS One. 2018 Sep 21;13(9):e0203874. doi: 10.1371/journal.pone.0203874. eCollection 2018. |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |