Steroid Tapering in Obese Patients with type 2 low asthma

Effect of inhaled corticosteroid tapering in obese T2-low asthma patients on asthma control and quality of life: an investigator-initiated, multicenter, non-inferiority, open label crossover trial with open label extension

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON23421

Enrollment

134

Registered

2020-07-06

Start date

2020-10-01

Completion date

Unknown

Last updated

2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

T2 low asthma and obesity

Interventions

ICS tapering/withdrawal

Eligibility

Inclusion criteria

Inclusion criteria: - Age 18-75 years - BMI = 30 kg/m2 - Confirmed asthma diagnoses (12% reversibility in FEV1 or PD20 0,75 - FEV = 70% of predicted - No exacerbation in past 3 months

Exclusion criteria

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 outcomes

Primary

Measure	Time frame
asthma control (geen klinisch significante stijging van de ACQ (= 0.5 punten) voor 4 dagen tijdens/na tapering)	—

Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Contacts

Public ContactJ.A. Witte

Franciscus Gasthuis en Vlietland

a.witte2@franciscus.nl010-4616148

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)