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OpenTrials
Completed

NCT Number: NCT03278561

General Risk Factors and Inflammatory Determinants in Older Patients With Asthma

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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);

Treatment and study plan

Sputum induction

Procedure

Sputum induction according to the ERS protocol

Blood sample

Procedure

A blood sample of 100ml will be taken.

Primary outcomes

  1. Differences in number and activation status of inflammatory cells in sputum and blood

    Time frame: 1 month

    To compare the differences in number and activation status of inflammatory cells in sputum and blood of different subgroups of asthmatics.)

Secondary outcomes

  1. Interleukin cell type 2 (ILC2) correlation and disease phenotype

    Time frame: 1 month

    To find correlations between ILC2 numbers and characteristics and immunological and clinical disease phenotype. -

  2. Hair cortisol

    Time frame: 1 month

    Detection of cortisol levels in hair, to determine a possible method to check Inhaled corticosteroid (ICS) adherence.

  3. Inflammatory profile

    Time frame: 1 month

    To measure physiological factors (lung function, activity level) and relate them to inflammatory profile.

  4. Selfmanagement / coping strategies

    Time frame: 1 month

    To investigate the relationship between duration and onset of asthma and self-management/coping strategies of patients.

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

    Time frame: 1 month

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

  6. Detection of different microbiome subgroups of asthmatics and compare with controls.

    Time frame: 1 month

    Detection of microflora/microbiome pattern in sputum and faeces in different subgroups of asthmatics and compare with controls.

Sponsors and collaborators

Lead sponsor

Gerdien Tramper

Other

Registry information

Acronym: GRANDMA

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Sep 11, 2017
Registry last updated
Aug 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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