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A better understanding of molecular mechanisms leading to asthma and its remission.

A better understanding of molecular mechanisms leading to asthma and its remission. - Asthma origins and remission study

Status
Unknown
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON45213
Enrollment
80
Registered
2015-10-20
Start date
Unknown
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

asthmatic bronchitis Bronchitis

Interventions

None listed

Sponsors

Universitair Medisch Centrum Groningen
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria for all subjects: • Age between 40 and 65 years old. • Smoking history 90% predicted. • Absence of bronchial hyperresponsiveness, i.e. both PC20 methacholine > 8 mg/ml and PC20 AMP > 320 mg/ml.;o Group 3. Patients with ongoing asthma • 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. • Use of inhaled corticosteroids or Either persistent symptoms of wheeze, cough, or dyspnea or regular use of β2 agonists at least once a week during the last 2 months. • PC20 methacholine 8 mg/ml, FEV1/FVC > 70% and FEV1 > 80% predicted.

Exclusion criteria

Exclusion criteria: • FEV1

Design outcomes

Primary

MeasureTime frame
The primary endparameter will be the difference in the transcriptomic profile of innate lymphocytes, CD4+ T cells, and CD8+ T cells and epithelial cells in bronchial biopsies and of blood eosinophils obtained from subjects with ongoing asthma, clinical or complete asthma remission and healthy controls.

Secondary

MeasureTime frame
Questionnaires Questionnaires will be the ELON questionnaire, the Asthma Control Questionnaire (ACQ), and the small airways dysfunction tool (SADT). Spirometry measurements: FEV1, FVC, FEF25, FEF50, FEF75 and FEF25-75. Body plethysmography: TLC, RV, FRC, VC, IVC. Specific airway conductance (sGaw), airway resistance (Raw). Impulse oscillometry (IOS): Parameters assessed with this test are: R5, R20, X5, R5-R20. Skin prick test for allergy Peripheral blood • Hemoglobin, leucocytes and differentiation, thrombocytes (10 mL peripheral blood; EDTA tube). • DNA and plasma (10 mL peripheral blood; EDTA tube). • RNA (10 mL, PAXgene tube) • Serum (10 mL peripheral blood serum tube). • Total IgE, Phadia-top and CRP will be measured in serum (10 mL peripheral blood serum tube). • PBMCs (40mL peripheral blood; heparin lithium tubes). Methacholine and Adenosine Monophosphate (AMP) provocation HRCT scan of the thorax Multiple Breath Nitrogen Washout (MBNW): Parameters assessed are LCI, Sacin, Scond. Exhaled Nitric Oxide (single breath at multiple flows) PExA: Particles in exhaled air. Inflammatory cell counts in bronchial biopsies and induced sputum. mRNA, non-coding small and large RNA, and DNA methylation in bronchial and brushes, nasal epithelial brushes.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)