Immunological phenotype of asthma severity (iPhase) - iPhase

Erasmus MC, Universitair Medisch Centrum Rotterdam0 个研究点目标入组 100 人开始时间: 待定最近更新: 2024年4月23日

适应症

试验速览

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•In order to be eligible to participate in this study, a subject must meet one of the following criteria:
•- Diagnosis of asthma confirmed by at least one of the following as assessed at least once during the 5 past years before the study:
•- 1. Reversibility to β2-agonists as shown by an increase from baseline in FEV1>= 12% predicted and >= 200 ml after 400 µg inhaled salbutamol or equivalent;
•- 2. Bronchial hyper-responsiveness (BHR) to metacholine (PD < 1.76) or histamine (PD < 2.59) as measured by standardized methods.
•- 3. Peak-flow variability of >20% ((PEFmax - PEFmin)/PEFmax) over a period of 14 days.
•- 4. Fall in FEV1>12% and >200ml when tapering of treatment (ICS, oral steroid, LABA and/or LTRA). ;We will include patients diagnosed with asthma and a recent (< 12 monts) metacholine provocation test, or histamine provocation test (PD20 < 1.76 mg). These test are performed in a standardized manner in both centers.
•o In this study we will compare three different asthmatic phenotypes. These phenotypes will be determined based on clinical features and inflammatory sputum profile;
•- Use inhaled corticosteroids daily and β2-agonists as required;
•- Given written informed consent;
•- Age: 18 - 50.

•A potential subject who meets any of the following criteria will be excluded from participation in this study:;- received systemic corticosteroid therapy (>= 7.5 mg/kg) within three months prior to inclusion;
•- no use of inhaled corticosteroids and β2-agonists
•- BMI > 35;
•- Smoking > 10 pack years;
•- Other diseases which could influence pulmonary function and/or the immune system such as:
•o A possible infection of the upper- or lower respiratory tract 4 weeks prior to the collection of materials;
•o Chronic obstructive pulmonary disorder (COPD) in the medical history;
•o Auto-immune diseases such as systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), myasthenia gravis or Goodpasture*s syndrome;
•o Malignancies;
•o Human immunodeficiency virus (HIV);
•o Pregnancy;
•o Other allergies except for allergic rhinitis.

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