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Towards Targeting the ORigin of the Inflammatory Cascade in Allergic Asthma | Clinical Trials | Clareo Health

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Towards Targeting the ORigin of the Inflammatory Cascade in Allergic Asthma

Towards Targeting the ORigin of the Inflammatory Cascade in Allergic Asthma: Cross-talk Between Airway Epithelium and Immune Cells

NCT04264377•University Medical Center Groningen

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 45 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Age between 18 and 45 years old.
•Smoking history ≤2 packyears.
•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 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.
•Group 2. Non-asthmatic controls
•* No history of asthma.
•* No use of inhaled corticosteroids or β2-agonists for a period longer than 1 month.
+2 more criteria

Exclusion Criteria

•FEV1 \<1.2 L,
•Subjects must be able to adhere to the study visit schedule and other protocol requirements.
•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:
•1. Surgical sterilization (e.g. bilateral tubal ligation, hysterectomy).
•2. Hormonal contraception (implantable, patch, oral, injectable).
+2 more criteria

Locations (1)

University Medical Center Groningen

Groningen, Netherlands

Key Dates

Start Date

February 7, 2020

Primary Completion Date

December 1, 2022

Completion Date

December 1, 2022

Last Updated

February 11, 2020

Enrollment

ESTIMATED participants

Conditions

AsthmaAllergic Asthma

Interventions

Bronchoscopy

PROCEDURE

Contacts

Maarten van den Berge, Dr

CONTACT

+3150-3615260 m.van.den.berge@umcg.nl

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 11, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Towards Targeting the ORigin of the Inflammatory Cascade in Allergic Asthma

Inclusion Criteria

Exclusion Criteria

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