Longitudinal Assessment of Adults With Severe Asthma

Study Overview
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Brief Summary
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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

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

Conditions
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Asthma

Participation Criteria
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Eligibility Criteria
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General Inclusion Criteria: 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. Male or female subject aged 18 years or older at screening. Able to complete the study and all measurements. Able to read, comprehend, and write at a sufficient level to complete study related materials. 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: 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. The subject has a history of recreational drug use or other allergy, which, in the opinion of the responsible physician, contra-indicates their participation. 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. 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. Those who, in the opinion of the investigator, have a risk of non-compliance with study procedures. The subject has a recent history of incapacitating psychiatric disorders 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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort A<br>Adults: severe asthmatics on high dose ICS and / or OCS | |
| Cohort B<br>Adults: current smokers or ex-smokers, severe asthmatics on high dose ICS and / or OCS | |
| Cohort C<br>Adults: non-smokers, mild to moderate asthmatics on regular inhaled corticosteroids (ICS) | |
| Cohort D<br>Adults: healthy volunteers, non-smokers, non-asthmatic with pre bronchodilator FEV1 > 80% predicted | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sputum, Clinical cohorts, Smokers, Asthma, Biopsies, Severe asthma, Collaborative research, Phenotyping, Lipidomics, Transcriptomics, Proteomics, Paediatric cohort, Systems Biology