Longitudinal Assessment of Adults With Severe Asthma

NCT ID: NCT01976767

Last Updated: 2015-01-14

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 725 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-04-30
• Study Completion Date: 2014-04-30

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

Conditions

Asthma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Cohort A

Adults: severe asthmatics on high dose ICS and / or OCS

No interventions assigned to this group

Cohort B

Adults: current smokers or ex-smokers, severe asthmatics on high dose ICS and / or OCS

No interventions assigned to this group

Cohort C

Adults: non-smokers, mild to moderate asthmatics on regular inhaled corticosteroids (ICS)

No interventions assigned to this group

Cohort D

Adults: healthy volunteers, non-smokers, non-asthmatic with pre bronchodilator FEV1 \> 80% predicted

No interventions assigned to this group

Eligibility Criteria

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.

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

OTHER

Sponsor Role: lead

Responsible Party

Prof. dr. P.J. Sterk

Prof. dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Peter Sterk, Dr.

Role: PRINCIPAL_INVESTIGATOR

Academic Medical Centre University of Amsterdam, The Netherlands

Ratko Djukanovic, Dr.

Role: PRINCIPAL_INVESTIGATOR

Southampton General Hospital, UK

Stephen Fowler, Dr.

Role: PRINCIPAL_INVESTIGATOR

Respiratory Research Group, Education and Research Centre, Wythenshawe Hospital, UK

Kian Fan Chung, Dr.

Role: PRINCIPAL_INVESTIGATOR

Imperial College London, UK

Barbro Dahlén, Dr.

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Andrew Szczeklik, Dr.

Role: PRINCIPAL_INVESTIGATOR

Uniwersytet Jagielloński - Collegium Medicum, Kraków, Poland

Thomas Geiser, Dr.

Role: PRINCIPAL_INVESTIGATOR

Inselspital and University of Bern, Switzerland

Ildiko Horvath, Dr.

Role: PRINCIPAL_INVESTIGATOR

University School of Medicine, Budapest, Hundary

Pascal Chanez, Dr.

Role: PRINCIPAL_INVESTIGATOR

Université de la Méditerranee, Marseille, France

Jens Hohlfeld, Dr.

Role: PRINCIPAL_INVESTIGATOR

Fraunhofer Institute for Toxicology and Experimental Medicine, Hannover

Thomas Sandström, Dr.

Role: PRINCIPAL_INVESTIGATOR

Department of Public Health and Clinical Medicine, Division of Medicine, Umea, Sweden

Dominick Shaw, Dr.

Role: PRINCIPAL_INVESTIGATOR

Nottingham City Hospita, Nottingham, UK

Per Sigvald Bakke, Dr.

Role: PRINCIPAL_INVESTIGATOR

Haukeland University Hospital, Bergen, Norway

Riccardo Polosa, Dr.

Role: PRINCIPAL_INVESTIGATOR

Policlinico Vittorio Emmanuele, Catania, Italy

Paolo Montuschi, Dr.

Role: PRINCIPAL_INVESTIGATOR

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

References

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.

Reference Type: DERIVED

PMID: 34824054 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 32667261 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 30240401 (View on PubMed)

Other Identifiers

10/H0721/66

Identifier Type: -

Identifier Source: org_study_id