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ID
Source
Brief title
Health condition
T2 low asthma and obesity
Sponsors and support
Intervention
Outcome measures
Primary outcome
asthma control (geen klinisch significante stijging van de ACQ (≥ 0.5 punten) voor 4 dagen tijdens/na tapering)
Secondary outcome
1. To determine predictive factors for successful ICS withdrawal.
2. To determine the effect of ICS withdrawal on determents of Metabolic Syndrome using physical examination (such as weight an blood pressure), blood- and hair tests (e.g. endocrine markers of metabolic syndrome and steroid levels)
3. To describe the effect of ICS on inflammatory biomarkers (e.g. proteomics and genomics) and physical parameters (e.g. lung function) in T2-low asthma.
4. To detect whether the T2-low status changes over time and during an exacerbation (i.e. detecting T2-hidden or false negative patients)
5. To further complement T2-phenotyping using exhaled molecular compounds analyses (i.e. electronic nose or eNose) which gives inside in potential early biomarkers for low steroid efficacy.
Background summary
Asthma patients with obesity often have a high burden of disease, despite the use of high dose inhaled corticosteroids (ICS). In contrast to asthma patients with normal weight, the efficacy of ICS in obese asthma patients is relatively low, meanwhile many patients suffer from side effects, such as weight gain, development of diabetes, cataract and high blood pressure. The low efficacy might be explained by the high prevalence of T2-low phenotypes in those patients, based on eosinophilic count, Fractional exhaled NO (FeNO), clinically allergy driven asthma of need for maintenance oral corticosteroids (OCS).[6-8] We aim to demonstrate that ICS can be safely withdrawn in T2-low asthma patients with obesity. Furthermore, we will study the efficacy of ICS, the prevalence of ‘false-negative’ T2-low phenotypes (i.e. T2-hidden) and the effect of ICS withdrawal on parameters of metabolic syndrome, to gain a better understanding of this poorly understood population and to find new treatable traits
Study objective
ICS can be safely withdrawn in T2-low asthma patients with obesity in secondary care (i.e. without loss of asthma control).
Study design
t=0w (inclusion), t=4w (start control period), t=18w (end control period), t=22 (start tapering), t=36 (end tapering)
Intervention
ICS tapering/withdrawal
Inclusion criteria
- Age 18-75 years
- BMI ≥ 30 kg/m2
- Confirmed asthma diagnoses (12% reversibility in FEV1 or PD20 < 2.36)[1]
- T2-low phenotype:
o Peripheral blood eosinophils < 150 cells/μL
o FeNO < 20 ppb
o No clinically proven allergen driven asthma
o No need for maintenance OCS
- Current ICS user
- ACQ > 0,75
- FEV ≥ 70% of predicted
- No exacerbation in past 3 months
Exclusion criteria
- Not a full understanding of the Dutch language.
- A liaison with the coordinating or principal investigator, which could possibly influence the decision to participate in this study voluntarily (in concordance with the WMO – article 5)
- Systematic use of oral, nasal or topical corticosteroids
- Use of immune suppressive drugs, such as biologicals/monoclonal antibodies, calcineurine inhibitors, mTOR inhibitors and IMDH inhibitors.
- Other diseases which could influence pulmonary function and/or the immune system such as:
-- A possible infection of the upper- or lower respiratory tract 6 weeks prior to the start of the study;
-- Active malignancy
-- Prior pulmonary malignancy
-- COPD diagnosis
-- Current pregnancy
-- Pregnancy
-- ‘Active smoking’ or ‘stopped smoking but >10 Pack Years’
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL8759 |
| CCMO | NL73155.100.20 |
| OMON | NL-OMON55120 |