AsthmaGRANDMANCT03278561
General Risk Factors and Inflammatory Determinants in Older Patients With Asthma
An observational study of Asthma and Late-Onset Asthma, run by Gerdien Tramper at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma, Late-Onset Asthma, Childhood Asthma
- What is being tested?
- Sputum induction and Blood sample
- Type of treatment
- Surgery or procedure
- How many people
- 90 participants
- Where
- 1 siteNetherlands
- Study dates
- 8 May 2017to 31 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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)
Who may be able to join
- 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.
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- Inclusion Criteria Healthy controls:\Inclusion criteria healthy control:
- Written informed consent
- Age between 18-80 years.
Who cannot join
- 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;
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- 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);
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- Sputum induction, Blood sample
- Keywords
- asthma, age of onset, inflammation, comorbidity, microbiome
- Medical subject headings
- Asthma, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sputum inductionProcedure or surgery
Sputum induction according to the ERS protocol
Blood sampleProcedure or surgery
A blood sample of 100ml will be taken.
| Study group | Role | What they receive |
|---|---|---|
| Early onset asthma | Sputum induction according to the European Respiratory Society (ERS) protocol. A blood sample of 100ml will be taken. Receives: Procedure: Sputum induction; Procedure: Blood sample | |
| Late onset asthma | Sputum induction according to the ERS protocol. A blood sample of 100ml will be taken. Receives: Procedure: Sputum induction; Procedure: Blood sample | |
| No pulmonary disease | Sputum induction according to the ERS protocol. A blood sample of 100ml will be taken. Receives: Procedure: Sputum induction; Procedure: Blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.)
Measured: 1 month
Secondary outcomes (6)
Interleukin cell type 2 (ILC2) correlation and disease phenotype
To find correlations between ILC2 numbers and characteristics and immunological and clinical disease phenotype. -
Measured: 1 month
Hair cortisol
Detection of cortisol levels in hair, to determine a possible method to check Inhaled corticosteroid (ICS) adherence.
Measured: 1 month
Inflammatory profile
To measure physiological factors (lung function, activity level) and relate them to inflammatory profile.
Measured: 1 month
Selfmanagement / coping strategies
To investigate the relationship between duration and onset of asthma and self-management/coping strategies of patients.
Measured: 1 month
The effect of aging on inflammation, physiology, psychology and co-morbidities in asthma.
The effect of aging on inflammation, physiology, psychology and co-morbidities in asthma.
Measured: 1 month
Detection of different microbiome subgroups of asthmatics and compare with controls.
Detection of microflora/microbiome pattern in sputum and faeces in different subgroups of asthmatics and compare with controls.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2017
- Study start8 May 2017
- Primary completion31 Aug 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gerdien Tramper
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Gerdien Tramper, Franciscus Gasthuis
- Investigators
- GM de Boer, MD, Principal investigator, Franciscus Gasthuis RotterdamGJ Braunstahl, MD, PhD, Principal investigator, Franciscus Gasthuis RotterdamGA Tramper, MD, PhD, Principal investigator, Franciscus Gasthuis Rotterdam
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03278561
- Sponsor's protocol ID
- GRANDMA
- Acronym
- GRANDMA
- Status last verified
- Aug 2020
- First submitted
- 8 Sep 2017
- Last updated
- 14 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- General Risk Factors and Inflammatory Determinants in Older Patients With Asthma
- ClinicalTrials.gov ID
- NCT03278561
- Acronym / sponsor ID
- GRANDMA / GRANDMA
- Conditions
- Asthma, Late-Onset Asthma, Childhood Asthma
- Keywords
- asthma, age of onset, inflammation, comorbidity, microbiome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Gerdien TramperUniversity, hospital or other
- Study start
- 8 May 2017 (actual)
- Primary completion
- 31 Aug 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 11 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Early onset asthma | – | Procedure: Sputum induction, Procedure: Blood sampleSputum induction according to the European Respiratory Society (ERS) protocol. A blood sample of 100ml will be taken. |
| Late onset asthma | – | Procedure: Sputum induction, Procedure: Blood sampleSputum induction according to the ERS protocol. A blood sample of 100ml will be taken. |
| No pulmonary disease | – | Procedure: Sputum induction, Procedure: Blood sampleSputum induction according to the ERS protocol. A blood sample of 100ml will be taken. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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)
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sputum inductionSputum induction according to the ERS protocol | Procedure or surgery | Early onset asthma, Late onset asthma, No pulmonary disease |
| Blood sampleA blood sample of 100ml will be taken. | Procedure or surgery | Early onset asthma, Late onset asthma, No pulmonary disease |
Primary outcome
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.)
6 secondary outcomes
Interleukin cell type 2 (ILC2) correlation and disease phenotype
Time frame: 1 month
Hair cortisol
Time frame: 1 month
Inflammatory profile
Time frame: 1 month
Selfmanagement / coping strategies
Time frame: 1 month
The effect of aging on inflammation, physiology, psychology and co-morbidities in asthma.
Time frame: 1 month
Detection of different microbiome subgroups of asthmatics and compare with controls.
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GM de Boer, MD principal investigator
Franciscus Gasthuis Rotterdam
GJ Braunstahl, MD, PhD principal investigator
Franciscus Gasthuis Rotterdam
GA Tramper, MD, PhD principal investigator
Franciscus Gasthuis Rotterdam
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma and Late-Onset Asthma, run by Gerdien Tramper at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences in number and activation status of inflammatory cells in sputum and blood (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2020.