General Risk Factors and Inflammatory Determinants in Older Patients With Asthma

NCT03278561 | Completed

• 1 other identifier: GRANDMA
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma; Late-Onset Asthma; Childhood Asthma

Keywords

asthma; age of onset; inflammation; comorbidity; microbiome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Interleukin cell type 2 (ILC2) correlation and disease phenotype

  1 month

• Hair cortisol

  1 month

• Inflammatory profile

  1 month

• Selfmanagement / coping strategies

  1 month

• The effect of aging on inflammation, physiology, psychology and co-morbidities in asthma.

  1 month

Study Arms (3)

Early onset asthma

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

Procedure: Sputum induction; Procedure: Blood sample

Late onset asthma

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

Procedure: Sputum induction; Procedure: Blood sample

No pulmonary disease

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

Procedure: Sputum induction; Procedure: Blood sample

Interventions

Sputum induction PROCEDURE

Sputum induction according to the ERS protocol

Early onset asthma; Late onset asthma; No pulmonary disease

Blood sample PROCEDURE

A blood sample of 100ml will be taken.

Early onset asthma; Late onset asthma; No pulmonary disease

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The aim is to enrol 30 patients with early onset asthma (age of onset \< 18 years) and 30 patients with late onset asthma (age of onset \> 18 years); all with a smoking history of \< 10 PY. Both groups consist of 15 older asthma patients (\> 50 years) and 15 younger asthma patients (\< 50 years); per age group 15 healthy controls serve as comparison (no asthma). Asthma diagnosis is based on presence of typical clinical symptoms, reversible airway obstruction (+12% improvement in FEV1 after bronchodilator) or bronchial hyperreactivity (PC20 \< 8 mg/ml) or a FeNO \> 50 ppb. All asthma patients have GINA step 4-5 medication (high dose ICS/LABA) and are not adequately controlled (ACQ \> 0,75)

You may qualify if:

• 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.

You may not qualify if:

• 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);

Sponsors & Collaborators

• Gerdien Tramper: lead

Study Sites (1)

Franciscus Gasthuis

Rotterdam, South Holland, 3045PM, Netherlands

Location

Biospecimen

Retention: SAMPLES WITH DNA

sputum, blood, NP swab, feces

MeSH Terms

Conditions

Asthma; Inflammation

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• GM de Boer, MD

  Franciscus Gasthuis Rotterdam

  PRINCIPAL INVESTIGATOR

• GJ Braunstahl, MD, PhD

  Franciscus Gasthuis Rotterdam

  PRINCIPAL INVESTIGATOR

• GA Tramper, MD, PhD

  Franciscus Gasthuis Rotterdam

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD PhD

Study Record Dates

• First Submitted: September 8, 2017
• First Posted: September 11, 2017
• Study Start: May 8, 2017
• Primary Completion: August 31, 2019
• Study Completion: December 31, 2019
• Last Updated: August 14, 2020

Record last verified: 2020-08

Locations

NL (1)