General Risk Factors and Inflammatory Determinants in Older Patients With Asthma

Completed

• Conditions: Asthma; Late-Onset Asthma; Childhood Asthma
• Interventions: Procedure: Sputum induction; Procedure: Blood sample

• Registration Number: NCT03278561
• Lead Sponsor: Gerdien Tramper

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.

Study Timeline

• Study Start: 2017-05-08
• Study First Submitted: 2017-09-08
• Study First Submitted QC: 2017-09-08
• Study First Posted: 2017-09-11
• Primary Completion: 2019-08-31
• Study Completion: 2019-12-31
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-13
• Last Update Posted: 2020-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

Not provided

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;

Exclusion criteria healthy controls:

• Asthma, as defined earlier (page 13);
• An abnormal spirometry with a forced vital capacity (FVC) or FEV1 below the 80% of the predicted value
• A liaison with the coordinating or principal investigator, which could likely influence the decision to participate in this study voluntarily (in concordance with the World Meteorological Organization (WMO) -article 5);

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Early onset asthma	Sputum induction	Sputum induction according to the European Respiratory Society (ERS) protocol. A blood sample of 100ml will be taken.
Late onset asthma	Blood sample	Sputum induction according to the ERS protocol. A blood sample of 100ml will be taken.
Late onset asthma	Sputum induction	Sputum induction according to the ERS protocol. A blood sample of 100ml will be taken.
Early onset asthma	Blood sample	Sputum induction according to the European Respiratory Society (ERS) protocol. A blood sample of 100ml will be taken.
No pulmonary disease	Sputum induction	Sputum induction according to the ERS protocol. A blood sample of 100ml will be taken.
No pulmonary disease	Blood sample	Sputum induction according to the ERS protocol. A blood sample of 100ml will be taken.

Primary Outcome Measures

Name	Time	Method
Differences in number and activation status of inflammatory cells in sputum and blood	1 month	To compare the differences in number and activation status of inflammatory cells in sputum and blood of different subgroups of asthmatics.)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Franciscus Gasthuis; 🇳🇱 Rotterdam, Zuid-Holland, Netherlands