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General Risk Factors and Inflammatory Determinants in Older Patients With Asthma

General Risk Factors and Inflammatory Determinants in Older Patients With Asthma

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03278561
Acronym
GRANDMA
Enrollment
90
Registered
2017-09-11
Start date
2017-05-08
Completion date
2019-12-31
Last updated
2020-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma, Late-Onset Asthma, Childhood Asthma

Keywords

asthma, age of onset, inflammation, comorbidity, microbiome

Brief summary

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.

Detailed description

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.

Interventions

Sputum induction according to the ERS protocol

PROCEDUREBlood sample

A blood sample of 100ml will be taken.

Sponsors

Gerdien Tramper
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

Inclusion criteria

Asthma patients: * Age between 18-80 years * Smoking history of \< 10 packyears (PY) * Willing and able to comply with the study protocol * Asthma diagnosis is based on presence of typical clinical symptoms, reversible airway obstruction (+12% improvement in forced expiratory volume at one second (FEV1) after bronchodilator) or bronchial hyperreactivity (PC20 \< 8 mg/ml) or a (fractional exhaled nitric oxide) FeNO \> 50 ppb. - All asthma patients have (Global Initiative for Asthma ) GINA step 4-5 medication (high dose ICS/LABA). * Asthma control questionaire (ACQ) \> 0,75 * Written informed consent. Inclusion Criteria Healthy controls:\\Inclusion criteria healthy control: * Written informed consent * Age between 18-80 years.

Exclusion criteria

* Smoking history of \> 10 PY * Age \< 18 years or \> 80 years * Not able to speak or write Dutch language. * Not able to perform lung function test/sputum induction * ACQ \< 0,75 * 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; * Chronic obstructive pulmonary disorder (COPD) in the medical history; * Auto-immune diseases such as systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), myasthenia gravis or Goodpasture's syndrome; * Malignancies; * Inherited or acquired immunodeficiency * Pregnancy;

Design outcomes

Primary

MeasureTime frameDescription
Differences in number and activation status of inflammatory cells in sputum and blood1 monthTo compare the differences in number and activation status of inflammatory cells in sputum and blood of different subgroups of asthmatics.)

Secondary

MeasureTime frameDescription
Hair cortisol1 monthDetection of cortisol levels in hair, to determine a possible method to check Inhaled corticosteroid (ICS) adherence.
Inflammatory profile1 monthTo measure physiological factors (lung function, activity level) and relate them to inflammatory profile.
Interleukin cell type 2 (ILC2) correlation and disease phenotype1 monthTo find correlations between ILC2 numbers and characteristics and immunological and clinical disease phenotype. -
The effect of aging on inflammation, physiology, psychology and co-morbidities in asthma.1 monthThe effect of aging on inflammation, physiology, psychology and co-morbidities in asthma.
Detection of different microbiome subgroups of asthmatics and compare with controls.1 monthDetection of microflora/microbiome pattern in sputum and faeces in different subgroups of asthmatics and compare with controls.
Selfmanagement / coping strategies1 monthTo investigate the relationship between duration and onset of asthma and self-management/coping strategies of patients.

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 15, 2026