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AsthmaNCT01976767

Longitudinal Assessment of Adults With Severe Asthma

An observational study of Asthma, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Asthma
How many people
725 participants
Where
No sites listed yet
Study dates
Apr 2011to Apr 2014
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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

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).

About this study

Official title: Protocol for the European Multi-Centre Study Understanding Severe Asthma Longitudinal Assessment of Adults With Severe Asthma

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
Keywords
Sputum, Clinical cohorts, Smokers, Asthma, Biopsies, Severe asthma, Collaborative research, Phenotyping, Lipidomics, Transcriptomics, Proteomics, Paediatric cohort, Systems Biology
Medical subject headings
Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01976767
Study groupRoleWhat they receive
Cohort AAdults: severe asthmatics on high dose ICS and / or OCS
Cohort BAdults: current smokers or ex-smokers, severe asthmatics on high dose ICS and / or OCS
Cohort CAdults: non-smokers, mild to moderate asthmatics on regular inhaled corticosteroids (ICS)
Cohort DAdults: healthy volunteers, non-smokers, non-asthmatic with pre bronchodilator FEV1 > 80% predicted

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Asthma exacerbations

    Number, duration and severity of exacerbations over the time of the study

    Measured: 3 years

  2. Lung function decline over the course of the study

    Measured: 3 years

  3. Changes in asthma medication

    in particular ICS dose, over the duration of the study

    Measured: 3 years

  4. Daily symptoms and short acting beta agonist (SABA) usage

    measured during the telemonitoring study

    Measured: 3 years

  5. Asthma control questionnaire (ACQ) at baseline and changes over the course of the study

    Measured: 3 years

  6. Upper airway symptoms as assessed by the sino-nasal outcomes test (SNOT) at baseline and changes over the course of the study

    Measured: 3 years

  7. Sleep and daytime drowsiness as assessed by the Epworth sleepiness scale at baseline and changes over the course of the study

    Measured: 3 years

  8. Measurement of pulmonary function including spirometry, plethysmography, bronchodilator reversibility and respiratory impedance by forced oscillation technique

    Measured: 3 years

  9. Radiological parameters such as computerized tomography (CT) scan, including assessment of lung structure

    Measured: 3 years

  10. Measurement of inflammatory cell counts in blood, sputum and bronchoalveolar lavage (BAL)

    Measured: 3 years

  11. Histopathology of bronchial biopsies in a sub group of subjects

    immunohistochemistry for inflammatory cells and matrix remodelling

    Measured: 3 years

  12. Transcriptomics, proteomics and metabolomics will be used on samples such as blood, urine and endobronchial biopsies

    to develop clinically useful phenotype handprints

    Measured: 3 years

  13. Quality of life as assessed by the asthma quality of life questionnaire (AQLQ)

    Measured: 3 years

  14. Anxiety and depression as assessed by the hospital anxiety and depression scale (HADS)

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Nov 2013 (estimated)
  2. Study startApr 2011
  3. Primary completionOct 2013
  4. Study completionApr 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
725 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01976767
Sponsor's protocol ID
10/H0721/66
Status last verified
Jan 2015
First submitted
22 Oct 2013
Last updated
14 Jan 2015
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 34824054

  • 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.

    PubMed 32667261

  • 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.

    PubMed 30240401

Questions about this trial

What is this clinical trial studying?

An observational study of Asthma, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Asthma exacerbations (time frame: 3 years). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01976767, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2015.

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