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

Withdrawn

• Conditions: asthmatic bronchitis; Bronchitis; 10006436

• Registration Number: NL-OMON45213
• Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 80

Inclusion Criteria

Inclusion criteria for all subjects:
• Age between 40 and 65 years old.
• Smoking history <= 10 packyears.;Inclusion criterium for asthma remission subjects:
• Onset of asthma symptoms <=21 years.;Specific inclusion criteria for the 4 different groups:
o Group 1. Subjects with clinical asthma remission:
• 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.
• No use of asthma medications such as inhaled or oral corticosteroids, β2-agonists or anticholinergics for 3 years.
• No symptoms of wheeze or asthma attacks during the last 3 years.
o Group 2. Subjects with complete asthma remission
• 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.
• No use of asthma medications such as inhaled or oral corticosteroids, β2-agonists or anticholinergics for 3 years.
• No symptoms of wheeze or asthma attacks during the last 3 years.
• FEV1 > 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.
o Group 4. Non-asthmatic controls
• No history of asthma.
• No use of inhaled corticosteroids or β2-agonists for a period longer than 1 month.
• No symptoms of wheeze, nocturnal dyspnea, or bronchial hyperresponsiveness.
• PC20 methacholine > 8 mg/ml, FEV1/FVC > 70% and FEV1 > 80% predicted.

Exclusion Criteria

• FEV1 <1.2 L,
• Upper respiratory tract infection (e.g. colds), within 6 weeks.
• Signs or symptoms of severe, progressive or uncontrolled renal, hepatic, hematologic, endocrine, pulmonary, cardiac, neurologic or cerebral disease.
• Malignancy within the past 5 years (except for squamous or basal cell carcinoma of the skin that has been treated with no evidence of recurrence).
• Known recent substance abuse (drug or alcohol).
• Females of childbearing potential without an efficient contraception

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endparameter will be the difference in the transcriptomic profile<br /><br>of innate lymphocytes, CD4+ T cells, and CD8+ T cells and epithelial cells in<br /><br>bronchial biopsies and of blood eosinophils obtained from subjects with ongoing<br /><br>asthma, clinical or complete asthma remission and healthy controls. </p><br>