ICS can be safely withdrawn in T2-low asthma patients with obesity in secondary care (i.e. without loss of asthma control).
ID
Bron
Verkorte titel
Aandoening
T2 low asthma and obesity
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
asthma control (geen klinisch significante stijging van de ACQ (≥ 0.5 punten) voor 4 dagen tijdens/na tapering)
Achtergrond van het onderzoek
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driven asthma of need for maintenance oral corticosteroids (OCS).[6-8] We aim to demonstrate that ICS can be safely withdrawn in T2-low asthma patients with obesity.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
Doel van het onderzoek
ICS can be safely withdrawn in T2-low asthma patients with obesity in secondary care (i.e. without loss of asthma control).
Onderzoeksopzet
t=0w (inclusion), t=4w (start control period), t=18w (end control period), t=22 (start tapering), t=36 (end tapering)
Onderzoeksproduct en/of interventie
ICS tapering/withdrawal
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- 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
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- 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’
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL8759 |
| CCMO | NL73155.100.20 |
| OMON | NL-OMON55120 |