General Risk Factors and Inflammatory Determinants in Older Patients With Asthma

Asthma Clinical Trial

— GRANDMA  

Official title:

General Risk Factors and Inflammatory Determinants in Older Patients With Asthma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03278561
• Other study ID #: GRANDMA
• Status: Completed
• Start date: May 8, 2017
• Est. completion date: December 31, 2019

Study information

• Verified date: August 2020
• Source: Franciscus Gasthuis
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: December 31, 2019
• Est. primary completion date: August 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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;

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);

Related Conditions & MeSH terms

• Asthma
• Childhood Asthma
• Late-Onset Asthma

Intervention

Procedure:
• Sputum induction
Sputum induction according to the ERS protocol
• Blood sample
A blood sample of 100ml will be taken.

Locations

Country	Name	City	State
Netherlands	Franciscus Gasthuis	Rotterdam	Zuid-Holland

Sponsors (1)

Lead Sponsor	Collaborator
Gerdien Tramper

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.)	1 month
Secondary	Interleukin cell type 2 (ILC2) correlation and disease phenotype	To find correlations between ILC2 numbers and characteristics and immunological and clinical disease phenotype. -	1 month
Secondary	Hair cortisol	Detection of cortisol levels in hair, to determine a possible method to check Inhaled corticosteroid (ICS) adherence.	1 month
Secondary	Inflammatory profile	To measure physiological factors (lung function, activity level) and relate them to inflammatory profile.	1 month
Secondary	Selfmanagement / coping strategies	To investigate the relationship between duration and onset of asthma and self-management/coping strategies of patients.	1 month
Secondary	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.	1 month
Secondary	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.	1 month