Towards Targeting the ORigin of the Inflammatory Cascade in Allergic Asthma

  • STATUS
    Recruiting
  • participants needed
    52
  • sponsor
    University Medical Center Groningen
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Updated on 16 February 2024
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corticosteroids
albuterol
dyspnea
bronchodilator
wheezing
methacholine
allergic asthma
cough
bronchial hyperreactivity
bronchoscopy
respiratory symptom

Summary

Allergic asthma is a complex and heterogeneous disease caused by excessive responses to inhaled allergens. Current medication, including corticosteroids and bronchodilators, does not act on the origin of inflammation but rather combats symptoms, leaving many patients uncontrolled. Airway epithelium is critical for the initiation and progression of asthma pathology.

We will include a 52 subjects divided over two groups: ongoing asthma (26 patients) and non-asthmatic healthy controls (26 subjects) in a cross-sectional study. All subjects will be extensively clinically characterized including respiratory symptoms/questionnaires, in- and expiratory CT-scans, and parameters of large and small airway function and inflammation. In addition, blood and nasal epithelial brushes will be obtained to study the genetic and epigenetic mechanisms of asthma. Finally, bronchoscopy with bronchial biopsies and brushes will be performed under conscious sedation. Bronchial biopsies from both patient groups will be used for single cell transcriptional analysis.

Details
Condition Asthma, Asthma, Asthma (Pediatric), Allergies & Asthma, Asthma (Pediatric), Allergies & Asthma, Allergic Asthma
Age 18years - 45years
Treatment Bronchoscopy
Clinical Study IdentifierNCT04264377
SponsorUniversity Medical Center Groningen
Last Modified on16 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

Inclusion criteria for all subjects
Age between 18 and 45 years old
Smoking history 2 packyears
Specific inclusion criteria for the two groups
Group 1. Patients with ongoing asthma
Age of onset of asthmatic symptoms: 0 - 18 years
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 g salbutamol)
Use of inhaled corticosteroids or either persistent symptoms of wheeze, cough, or dyspnea or regular use of 2 agonists at least once a week during the last 2 months
PC20 methacholine < 8 mg/ml
Group 2. Non-asthmatic controls
No history of asthma
No use of inhaled corticosteroids or 2-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
Subjects must be able to adhere to the study visit schedule and other protocol requirements
A subject is not eligible to enter and participate if he has not signed and dated a written informed consent form prior to participation in the study
A subjects is not eligible to enter and participate if he does not agree that we inform his general practitioner
Upper respiratory tract infection (e.g. colds), within 6 weeks
Serious acute infections (such as hepatitis, pneumonia or pyelonephritis) in the previous 3 months
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 unless they meet the following definition of post-menopausal: 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with serum FSH >40 mIU/mL or the use of one or more of the following acceptable methods of contraception
Surgical sterilization (e.g. bilateral tubal ligation, hysterectomy)
Hormonal contraception (implantable, patch, oral, injectable)
Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/cream/suppository
Continuous abstinence
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corticosteroids
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wheezing
methacholine
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cough
bronchial hyperreactivity
bronchoscopy
respiratory symptom

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