Longitudinal Assessment of Adults With Severe Asthma

January 13, 2015 updated by: Prof. dr. P.J. Sterk, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
725

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Asthma exacerbations
Time Frame: 3 years
Number, duration and severity of exacerbations over the time of the study
3 years
Lung function decline over the course of the study
Time Frame: 3 years
3 years
Changes in asthma medication
Time Frame: 3 years
in particular ICS dose, over the duration of the study
3 years
Daily symptoms and short acting beta agonist (SABA) usage
Time Frame: 3 years
measured during the telemonitoring study
3 years
Asthma control questionnaire (ACQ) at baseline and changes over the course of the study
Time Frame: 3 years
3 years
Upper airway symptoms as assessed by the sino-nasal outcomes test (SNOT) at baseline and changes over the course of the study
Time Frame: 3 years
3 years
Sleep and daytime drowsiness as assessed by the Epworth sleepiness scale at baseline and changes over the course of the study
Time Frame: 3 years
3 years
Measurement of pulmonary function including spirometry, plethysmography, bronchodilator reversibility and respiratory impedance by forced oscillation technique
Time Frame: 3 years
3 years
Radiological parameters such as computerized tomography (CT) scan, including assessment of lung structure
Time Frame: 3 years
3 years
Measurement of inflammatory cell counts in blood, sputum and bronchoalveolar lavage (BAL)
Time Frame: 3 years
3 years
Histopathology of bronchial biopsies in a sub group of subjects
Time Frame: 3 years
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
Time Frame: 3 years
to develop clinically useful phenotype handprints
3 years
Quality of life as assessed by the asthma quality of life questionnaire (AQLQ)
Time Frame: 3 years
3 years
Anxiety and depression as assessed by the hospital anxiety and depression scale (HADS)
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: 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
  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 22, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 30, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 6, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 14, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 13, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 10/H0721/66

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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