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Towards Targeting the Origin of Asthma: Cross-talk between airway epithelium and immune cells

Towards Targeting the Origin of Asthma: Cross-talk between airway epithelium and immune cells - ORIENT

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON49140
Enrollment
78
Registered
2020-02-05
Start date
2020-02-21
Completion date
Unknown
Last updated
2024-04-15

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

Conditions

bronchitis

Interventions

None listed

Sponsors

Universitair Medisch Centrum Groningen
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: All groups: • Age between 18 and 65. o Group 1. Patients with asthma, GINA step 1-3 (who stop using ICS/LABA in order to partake in the study) • Documented history of asthma diagnosed according to latest GINA guidelines, i.e. respiratory symptoms and either bronchodilator reversibility (improvement in FEV1 of more than 12% of baseline (and at least 200 mL) after inhalation of 800 µg salbutamol) or PC20 methacholine 8 mg/ml, FEV1/FVC > 70% and FEV1 > 80% predicted.

Exclusion criteria

Exclusion criteria: • FEV1 40 mIU/mL or the use of one or more of the following acceptable methods of contraception: a) Surgical sterilization (e.g. bilateral tubal ligation, hysterectomy). b) Hormonal contraception (implantable, patch, oral, injectable).

Design outcomes

Primary

MeasureTime frame
Identify key in vivo pathogenic features of airway wall cells in asthma, as reflected by single-cell transcriptomics of primary bronchial epithelial cells (BEC), as well as mesenchymal, endothelial and immune cells.

Secondary

MeasureTime frame
Questionnaires: ELON, ACQ, SADT and post-bronchoscopy questionnaire. Spirometry: FEV1, FVC, FEF25, FEF50, FEF75, FEF 25-75. Body box: TLC, RV

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)