AsthmaORIENTNCT04264377
Towards Targeting the ORigin of the Inflammatory Cascade in Allergic Asthma
An observational study of Asthma and Allergic Asthma, run by University Medical Center Groningen at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma, Allergic Asthma
- What is being tested?
- Bronchoscopy
- Type of treatment
- Surgery or procedure
- How many people
- 52 participants
- Where
- 1 siteNetherlands
- Study dates
- 7 Feb 2020to Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Asthma and healthy subjects
Who may be able to join
- 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 µg salbutamol).
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- 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.
- No symptoms of wheeze, nocturnal dyspnea, or bronchial hyperresponsiveness.
- PC20 methacholine > 8 mg/ml, FEV1/FVC > 70% and FEV1 > 80% predicted.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
University Medical Center Groningen
Groningen, 9713GZ
Maarten van den Berge, MD, PhD, +31-50-2615260, m.van.den.berge@umcg.nl
Maarten van den Berge, MD, PhD
About this study
Official title: Towards Targeting the ORigin of the Inflammatory Cascade in Allergic Asthma: Cross-talk Between Airway Epithelium and Immune Cells
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.
- Conditions
- Asthma, Allergic Asthma
- Being tested
- Bronchoscopy
- Keywords
- Epigenetics, Airway wall remodeling
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BronchoscopyProcedure or surgery
Bronchoscopy for retrieval of airway cells
| Study group | Role | What they receive |
|---|---|---|
| Healthy | 26 healthy subjects Receives: Procedure: Bronchoscopy | |
| Asthma | 26 subjects with asthma Receives: Procedure: Bronchoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Single-cell transcriptomics bronchial epithelial cell (BEC)
Measured: december 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2020
- Study start7 Feb 2020
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maarten van den Berge, University Medical Center Groningen
- Investigators
- Maarten van den Berge, Dr., Principal investigator, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04264377
- Sponsor's protocol ID
- 201900308
- Acronym
- ORIENT
- Status last verified
- Feb 2020
- First submitted
- 7 Feb 2020
- Last updated
- 11 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Towards Targeting the ORigin of the Inflammatory Cascade in Allergic Asthma: Cross-talk Between Airway Epithelium and Immune Cells
- ClinicalTrials.gov ID
- NCT04264377
- Acronym / sponsor ID
- ORIENT / 201900308
- Conditions
- Asthma, Allergic Asthma
- Keywords
- Epigenetics, Airway wall remodeling
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- 7 Feb 2020 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 11 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy | – | Procedure: Bronchoscopy26 healthy subjects |
| Asthma | – | Procedure: Bronchoscopy26 subjects with asthma |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Asthma and healthy subjects
Key inclusion criteria (13 listed)
- Age between 18 and 45 years old.
- Smoking history ≤2 packyears.
- Group 1. Patients with ongoing asthma
- Group 2. Non-asthmatic controls
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BronchoscopyBronchoscopy for retrieval of airway cells | Procedure or surgery | Asthma, Healthy |
Primary outcome
Single-cell transcriptomics bronchial epithelial cell (BEC)
Time frame: december 2022
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maarten van den Berge, Dr. principal investigator
University Medical Center Groningen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma and Allergic Asthma, run by University Medical Center Groningen at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maarten van den Berge, Dr (+3150-3615260, m.van.den.berge@umcg.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Single-cell transcriptomics bronchial epithelial cell (BEC) (time frame: december 2022). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2020.