Clinical trial NCT01976767: Longitudinal Assessment of Adults With Severe Asthma
Official title: Protocol for the European Multi-Centre Study Understanding Severe Asthma Longitudinal Assessment of Adults With Severe Asthma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Keywords: Sputum
Clinical cohorts
Smokers
Asthma
Biopsies
Severe asthma
Collaborative research
Phenotyping
Lipidomics
Transcriptomics
Proteomics
Paediatric cohort
Systems Biology
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
First posted: 2013-11-06
Enrollment: 725
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * Severe asthma cohorts: uncontrolled asthma symptoms or frequent severe exacerbations
* Mild-moderate asthma cohorts: controlled or partially controlled asthma symptoms
* Healthy controls: non-asthmatic healthy individuals free of significant disease

Brief summary: 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


Eligibility criteria: General Inclusion Criteria:

1. Able to give written informed consent prior to participation in the study, which includes ability to comply with the requirements and restrictions listed in the consent form. Informed consent must be obtained prior to undertaking any study procedures.
2. Male or female subject aged 18 years or older at screening.
3. Able to complete the study and all measurements.
4. Able to read, comprehend, and write at a sufficient level to complete study related materials.
5. Subjects will be allowed to enrol in other studies while taking part on this study. However, Permission from the Scientific Board must be obtained to enrol or allow the continued participation of a subject enrolled in another study.

General Exclusion Criteria:

1. As a result of medical interview, physical examination or screening investigation the physician responsible considers the subject unfit for the study either because of the risk to the subject due to the study or the influence this may have on the study results.
2. The subject has a history of recreational drug use or other allergy, which, in the opinion of the responsible physician, contra-indicates their participation.
3. Subject is female who is pregnant or lactating or up to 6 weeks post partum or 6 weeks cessation of breast feeding. If a woman is subsequently found to have been pregnant at the time of an assessment data from that assessment will not be included in the analyses.
4. The subject has participated within 3 months of the first dose in a study using a new molecular entity, or the first dose in any other study investigating drugs or having participated within three months in a study with invasive procedures. Any U-BIOPRED assessments should be deferred until 3 months after the first dose or invasive procedure. Permission from the Scientific Board must be obtained to enroll or allow the continued participation of a subject enrolled in another study.
5. Those who, in the opinion of the investigator, have a risk of non-compliance with study procedures.
6. The subject has a recent history of incapacitating psychiatric disorders
7. History or current evidence of an upper or lower respiratory infection or symptoms (including common cold) within 2 weeks of baseline assessments (assessments should be deferred).

Primary outcomes:
measure: Asthma exacerbations
timeFrame: 3 years
measure: Lung function decline over the course of the study
timeFrame: 3 years
measure: Changes in asthma medication
timeFrame: 3 years
measure: Daily symptoms and short acting beta agonist (SABA) usage
timeFrame: 3 years
measure: Asthma control questionnaire (ACQ) at baseline and changes over the course of the study
timeFrame: 3 years
measure: Upper airway symptoms as assessed by the sino-nasal outcomes test (SNOT) at baseline and changes over the course of the study
timeFrame: 3 years
measure: Sleep and daytime drowsiness as assessed by the Epworth sleepiness scale at baseline and changes over the course of the study
timeFrame: 3 years
measure: Measurement of pulmonary function including spirometry, plethysmography, bronchodilator reversibility and respiratory impedance by forced oscillation technique
timeFrame: 3 years
measure: Radiological parameters such as computerized tomography (CT) scan, including assessment of lung structure
timeFrame: 3 years
measure: Measurement of inflammatory cell counts in blood, sputum and bronchoalveolar lavage (BAL)
timeFrame: 3 years
measure: Histopathology of bronchial biopsies in a sub group of subjects
timeFrame: 3 years
measure: Transcriptomics, proteomics and metabolomics will be used on samples such as blood, urine and endobronchial biopsies
timeFrame: 3 years
measure: Quality of life as assessed by the asthma quality of life questionnaire (AQLQ)
timeFrame: 3 years
measure: Anxiety and depression as assessed by the hospital anxiety and depression scale (HADS)
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Academic Medical Centre University of Amsterdam, The Netherlands
name: Peter Sterk, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Southampton General Hospital, UK
name: Ratko Djukanovic, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Respiratory Research Group, Education and Research Centre, Wythenshawe Hospital, UK
name: Stephen Fowler, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Imperial College London, UK
name: Kian Fan Chung, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Karolinska Institutet
name: Barbro Dahlén, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Uniwersytet Jagielloński - Collegium Medicum, Kraków, Poland
name: Andrew Szczeklik, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Inselspital and University of Bern, Switzerland
name: Thomas Geiser, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: University School of Medicine, Budapest, Hundary
name: Ildiko Horvath, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Université de la Méditerranee, Marseille, France
name: Pascal Chanez, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Fraunhofer Institute for Toxicology and Experimental Medicine, Hannover
name: Jens Hohlfeld, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Public Health and Clinical Medicine, Division of Medicine, Umea, Sweden
name: Thomas Sandström, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Nottingham City Hospita, Nottingham, UK
name: Dominick Shaw, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Haukeland University Hospital, Bergen, Norway
name: Per Sigvald Bakke, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Policlinico Vittorio Emmanuele, Catania, Italy
name: Riccardo Polosa, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
name: Paolo Montuschi, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.