Towards Targeting the Origin of Asthma: Cross-talk between airway epithelium and immune cells - ORIENT

niversitair Medisch Centrum Groningen0 个研究点目标入组 78 人开始时间: 待定最近更新: 2024年4月15日

适应症

试验速览

暂无简介。

•All groups:
•Age between 18 and 65.
•o Group 1. Patients with asthma, GINA step 1-3 (who stop using ICS/LABA in
•order to partake in the study)
•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) or PC20 methacholine < 8 mg/ml.
•Use of low or medium dose inhaled corticosteroids, possibly combined with
•LABA (as GINA step 2-3) at baseline 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 (step 1).
•o Group 2: Patients with asthma GINA class 2-5 (who continue using their
•medication)
•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) or PC20 methacholine < 8 mg/ml.
•Use of inhaled or oral corticosteroids.
•o Group 3: Non-asthmatic controls
•No history of asthma.
•No use of inhaled corticosteroids or β2-agonists for a period longer than 1
•month in their lifetime and not during the 6 weeks before inclusion.
•No symptoms of wheeze, nocturnal dyspnea, or bronchial hyperresponsiveness.
•PC20 methacholine > 8 mg/ml, FEV1/FVC > 70% and FEV1 > 80% predicted.

•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 subject is not eligible to enter and participate if he does not agree that
•we inform his general practitioner and will inform them of incidental findings.
•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:
•a) Surgical sterilization (e.g. bilateral tubal ligation,
•hysterectomy).
•b) Hormonal contraception (implantable, patch, oral, injectable).

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