General Risk Factors and Inflammatory Determinants in Older Patients With Asthma

NCT ID: NCT03278561

Last Updated: 2020-08-14

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 90 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-05-08
• Study Completion Date: 2019-12-31

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.

Conditions

Asthma; Late-Onset Asthma; Childhood Asthma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Early onset asthma

Sputum induction according to the European Respiratory Society (ERS) protocol. A blood sample of 100ml will be taken.

Sputum induction

Intervention Type: PROCEDURE

Sputum induction according to the ERS protocol

Blood sample

Intervention Type: PROCEDURE

A blood sample of 100ml will be taken.

Late onset asthma

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

Sputum induction

Intervention Type: PROCEDURE

Sputum induction according to the ERS protocol

Blood sample

Intervention Type: PROCEDURE

A blood sample of 100ml will be taken.

No pulmonary disease

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

Sputum induction

Intervention Type: PROCEDURE

Sputum induction according to the ERS protocol

Blood sample

Intervention Type: PROCEDURE

A blood sample of 100ml will be taken.

Interventions

Sputum induction

Sputum induction according to the ERS protocol

Intervention Type: PROCEDURE

Blood sample

A blood sample of 100ml will be taken.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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.

• 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;

• 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);

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Gerdien Tramper

OTHER

Sponsor Role: lead

Responsible Party

Gerdien Tramper

MD PhD

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

GM de Boer, MD

Role: PRINCIPAL_INVESTIGATOR

Franciscus Gasthuis Rotterdam

GJ Braunstahl, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Franciscus Gasthuis Rotterdam

GA Tramper, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Franciscus Gasthuis Rotterdam

Locations

Franciscus Gasthuis

Rotterdam, South Holland, Netherlands

Countries

Netherlands

Other Identifiers

GRANDMA

Identifier Type: -

Identifier Source: org_study_id