General Risk Factors and Inflammatory Determinants in Older Patients With Asthma (GRANDMA)

Gerdien Tramper

Status

Completed

Conditions

Asthma

Childhood Asthma

Late-Onset Asthma

Treatments

Procedure: Blood sample

Procedure: Sputum induction

Study type

Observational

Funder types

Other

Identifiers

NCT03278561

GRANDMA

Details and patient eligibility

About

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.

Full 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.

Enrollment

90 patients

Sex

All

Ages

18 to 80 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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);