Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:05 PM
Ignite Modification Date:
2025-12-24 @ 1:05 PM
NCT ID:
NCT03278561
Eligibility Criteria:
Inclusion Criteria Asthma patients:
* Age between 18-80 years
* Smoking history of \< 10 packyears (PY)
* Willing and able to comply with the study protocol
* Asthma diagnosis is based on presence of typical clinical symptoms, reversible airway obstruction (+12% improvement in forced expiratory volume at one second (FEV1) after bronchodilator) or bronchial hyperreactivity (PC20 \< 8 mg/ml) or a (fractional exhaled nitric oxide) FeNO \> 50 ppb. - All asthma patients have (Global Initiative for Asthma ) GINA step 4-5 medication (high dose ICS/LABA).
* Asthma control questionaire (ACQ) \> 0,75
* Written informed consent.
Inclusion Criteria Healthy controls:\\Inclusion criteria healthy control:
* Written informed consent
* Age between 18-80 years.
Exclusion Criteria:
* Smoking history of \> 10 PY
* Age \< 18 years or \> 80 years
* Not able to speak or write Dutch language.
* Not able to perform lung function test/sputum induction
* ACQ \< 0,75
* 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;
* Chronic obstructive pulmonary disorder (COPD) in the medical history;
* Auto-immune diseases such as systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), myasthenia gravis or Goodpasture's syndrome;
* Malignancies;
* Inherited or acquired immunodeficiency
* Pregnancy;
Exclusion criteria healthy controls:
* Asthma, as defined earlier (page 13);
* An abnormal spirometry with a forced vital capacity (FVC) or FEV1 below the 80% of the predicted value
* A liaison with the coordinating or principal investigator, which could likely influence the decision to participate in this study voluntarily (in concordance with the World Meteorological Organization (WMO) -article 5);
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT03278561
Study Brief:
Protocol Section:
NCT03278561