An observational study in Asthma, Late-Onset Asthma and Childhood Asthma, sponsored by Gerdien Tramper. Completed at 1 site in Netherlands. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-08-14.
Sponsored by Gerdien Tramper · Observational
A cross-sectional study in asthma patients to determine if a late age of onset asthma (start symptoms >18 years old), is associated with more persistent airway/systemic inflammation, worse asthma control, more co-morbidity, a different microbiome and poorer quality of life despite the use of optimized asthma therapy.
For ages, asthma has been considered a disease for children and young adults. However, nowadays 30% of all asthma patients is over 50 years old. Asthma in the elderly is generally more severe and approximately 50% of all deaths drom asthma occur in this age group. With rapid aging of the global population, the burden of asthma in the elderly will further increase.
Asthma is a heterogeneous disease and the question is whether asthma in the elderly can be considered the same disease as asthma in children and young adults. The pathophysiology and risk factors of asthma in the elderly are still not completely understood. Good characterization of asthma in the elderly requires clinical phenotyping as well as a thorough analysis of the underlying cellular and molecular mechanisms. It is hypothesized that in older asthma patients, a late age of onset (start asthma symptoms >18 years) is associated with more persistent airway/systemic inflammation, worse asthma control, more co-morbidity and poorer quality of life despite the use of optimized asthma therapy.
4,841 studies on the registry are indexed under Asthma; 600 are open to participants now.
This study's enrollment of 90 is below the median of 158 across 1,250 observational studies indexed under Asthma.
Browse Asthma studies →This is the only study on the registry with Gerdien Tramper as lead sponsor.
Counted across the registry records on this site, refreshed daily.
The aim is to enrol 30 patients with early onset asthma (age of onset \< 18 years) and 30 patients with late onset asthma (age of onset > 18 years); all with a smoking history of \< 10 PY. Both groups consist of 15 older asthma patients (> 50 years) and 15 younger asthma patients (\< 50 years); per age group 15 healthy controls serve as comparison (no asthma). Asthma diagnosis is based on presence of typical clinical symptoms, reversible airway obstruction (+12% improvement in FEV1 after bronchodilator) or bronchial hyperreactivity (PC20 \< 8 mg/ml) or a FeNO > 50 ppb. All asthma patients have GINA step 4-5 medication (high dose ICS/LABA) and are not adequately controlled (ACQ > 0,75)
Inclusion Criteria Asthma patients:
Inclusion Criteria Healthy controls:\Inclusion criteria healthy control:
Exclusion Criteria:
Other diseases which could influence pulmonary function and/or the immune system such as: o A possible infection of the upper- or lower respiratory tract 4 weeks prior to the collection of materials;
Exclusion criteria healthy controls:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Sputum induction according to the European Respiratory Society (ERS) protocol. A blood sample of 100ml will be taken.
Procedure: Sputum induction · Procedure: Blood sample
Sputum induction according to the ERS protocol. A blood sample of 100ml will be taken.
Procedure: Sputum induction · Procedure: Blood sample
Sputum induction according to the ERS protocol. A blood sample of 100ml will be taken.
Procedure: Sputum induction · Procedure: Blood sample
Sputum induction according to the ERS protocol
A blood sample of 100ml will be taken.
Differences in number and activation status of inflammatory cells in sputum and blood
To compare the differences in number and activation status of inflammatory cells in sputum and blood of different subgroups of asthmatics.)
Time frame: 1 month
Interleukin cell type 2 (ILC2) correlation and disease phenotype
To find correlations between ILC2 numbers and characteristics and immunological and clinical disease phenotype. -
Time frame: 1 month
Hair cortisol
Detection of cortisol levels in hair, to determine a possible method to check Inhaled corticosteroid (ICS) adherence.
Time frame: 1 month
Inflammatory profile
To measure physiological factors (lung function, activity level) and relate them to inflammatory profile.
Time frame: 1 month
Selfmanagement / coping strategies
To investigate the relationship between duration and onset of asthma and self-management/coping strategies of patients.
Time frame: 1 month
The effect of aging on inflammation, physiology, psychology and co-morbidities in asthma.
The effect of aging on inflammation, physiology, psychology and co-morbidities in asthma.
Time frame: 1 month
Detection of different microbiome subgroups of asthmatics and compare with controls.
Detection of microflora/microbiome pattern in sputum and faeces in different subgroups of asthmatics and compare with controls.
Time frame: 1 month
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from May 2017 to primary completion in Aug 2019, 27 months.
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This study is completed, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.
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