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

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ClinicalTrials.gov Identifier: NCT03278561
Recruitment Status : Recruiting
First Posted : September 11, 2017
Last Update Posted : September 12, 2017
Sponsor:
Information provided by (Responsible Party):
Gert Jan Braunstahl / Gerdien Tramper, Franciscus Gasthuis

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.

Condition or disease Intervention/treatment
Asthma Late-Onset Asthma Childhood Asthma Procedure: Sputum induction Procedure: Blood sample

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.


Study Type : Observational
Estimated Enrollment : 90 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: General Risk Factors and Inflammatory Determinants in Older Patients With Asthma
Actual Study Start Date : May 8, 2017
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
U.S. FDA Resources

Group/Cohort Intervention/treatment
Early onset asthma
Sputum induction according to the European Respiratory Society (ERS) protocol. A blood sample of 100ml will be taken.
Procedure: Sputum induction
Sputum induction according to the ERS protocol
Procedure: Blood sample
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.
Procedure: Sputum induction
Sputum induction according to the ERS protocol
Procedure: Blood sample
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.
Procedure: Sputum induction
Sputum induction according to the ERS protocol
Procedure: Blood sample
A blood sample of 100ml will be taken.



Primary Outcome Measures :
  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 Outcome Measures :
  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.


Biospecimen Retention:   Samples With DNA
sputum, blood, NP swab, feces


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)
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);

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03278561


Contacts
Contact: GM de Boer, MD +31104616161 ext +31755 G.Boer3@franciscus.nl

Locations
Netherlands
Franciscus Gasthuis Recruiting
Rotterdam, Zuid-Holland, Netherlands, 3045PM
Contact: GM de Boer, MD    +31104616161 ext +13755    G.Boer3@franciscus.nl   
Contact: GJ Braunstahl, MD, PhD    +311046146161    G.Braunstahl@franciscus.nl   
Principal Investigator: GJ Braunstahl, MD, PhD         
Sponsors and Collaborators
Gert Jan Braunstahl / Gerdien Tramper
Investigators
Principal Investigator: 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

Responsible Party: Gert Jan Braunstahl / Gerdien Tramper, MD PhD, Franciscus Gasthuis
ClinicalTrials.gov Identifier: NCT03278561     History of Changes
Other Study ID Numbers: GRANDMA
First Posted: September 11, 2017    Key Record Dates
Last Update Posted: September 12, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Gert Jan Braunstahl / Gerdien Tramper, Franciscus Gasthuis:
asthma
age of onset
inflammation
comorbidity
microbiome

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases