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Immunological phenotype of asthma severity (iPhase)

Immunological phenotype of asthma severity (iPhase) - iPhase

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON44844
Enrollment
100
Registered
2015-02-20
Start date
2015-10-20
Completion date
Unknown
Last updated
2024-04-23

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

Conditions

astma patiënten Asthma respiratory disorder

Interventions

None listed

Sponsors

Erasmus MC, Universitair Medisch Centrum Rotterdam
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: In order to be eligible to participate in this study, a subject must meet one of the following criteria: - Diagnosis of asthma confirmed by at least one of the following as assessed at least once during the 5 past years before the study: - 1. Reversibility to β2-agonists as shown by an increase from baseline in FEV1>= 12% predicted and >= 200 ml after 400 µg inhaled salbutamol or equivalent; - 2. Bronchial hyper-responsiveness (BHR) to metacholine (PD 20% ((PEFmax - PEFmin)/PEFmax) over a period of 14 days. - 4. Fall in FEV1>12% and >200ml when tapering of treatment (ICS, oral steroid, LABA and/or LTRA). ;We will include patients diagnosed with asthma and a recent (

Exclusion criteria

Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study:;- received systemic corticosteroid therapy (>= 7.5 mg/kg) within three months prior to inclusion; - no use of inhaled corticosteroids and β2-agonists - BMI > 35; - Smoking > 10 pack years; - 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; o Chronic obstructive pulmonary disorder (COPD) in the medical history; o Auto-immune diseases such as systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), myasthenia gravis or Goodpasture*s syndrome; o Malignancies; o Human immunodeficiency virus (HIV); o Pregnancy; o Other allergies except for allergic rhinitis.

Design outcomes

Primary

MeasureTime frame
Cell numbers and activation of Th subsets, DCs, ILC2s and granulocytes will be determined in peripheral blood and induced sputum of controlled, partly controlled and uncontrolled asthma patients and healthy controls.

Secondary

MeasureTime frame
- To compare the differences in activation status in DCs, and to identify correlations with immunological and clinical disease phenotype - To compare the differences in activation status in T cell subsets, and to identify correlations with immunological and clinical disease phenotype - To establish whether T helper cell polarization by DCs is altered in asthma patients - To find correlations between ILC2 numbers and characteristics and immunological and clinical disease phenotype

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)