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 @ 12:21 PM
Ignite Modification Date:
2025-12-24 @ 12:21 PM
NCT ID:
NCT04061161
Eligibility Criteria:
Inclusion Criteria:
* • Men or women, age \>= 40 years.
* A diagnosis of COPD according to the criteria of the GOLD organization
* Post-bronchodilator FEV1 / FVC ratio \< 70% (ERS equations) and post-bronchodilator FEV1 \< 80%pred.
* A smoking history of \> 10 pack years.
* post-bronchodilator FEV1 \> 1.5 Litres and ability to produce sputum after hypertonic saline induction.
* No upper or lower respiratory tract infection in the last 4 weeks necessitating antibiotic treatment or consisting of quite probable viral etiology.
* Being in a stable phase of COPD, as judged by the investigator. No courses of systemic steroids or antibiotics for respiratory problems last 4 weeks
* The participant needs to be able to understand the Dutch language
* Signed and dated informed consent obtained before any study related procedures (including withdrawal of concomitant medication) are conducted.
Exclusion Criteria:
* • Treatment with immune-modulating agents for any disease, including leuktriene receptor antagonists,
* Treatment with long-acting anticholinergics \<4 weeks before the start of the study.
* Treatment with corticosteroids \<4 weeks before the start of the study.
* Targeted lung denervation therapy in the past.
* Concomitant diagnosis of asthma.
* Any significant other pulmonary disease or disorder (e.g. known alpha1-antitrypsine deficiency, significant bronchiectasis), as judged by the investigator.
* Narrow angle glaucoma.
* Azithromycine maintenance treatment.
* Active malignant disease (at least 5 years malignant disease-free)
* Other significant disease or disorder (like cardiovascular, gastrointestinal, liver, renal, neurological, musculoskeletal, endocrine, metabolic (including diagnosed diabetes), malignant, psychiatric, major physical impairment), which, in the opinion of the investigators may either put the patient at risk because of participation in the study, or may influence the results of the study, or the patient's ability to participate in the study.
* 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).
3. Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/cream/suppository.
4. Continuous abstinence.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Study:
NCT04061161
Study Brief:
Protocol Section:
NCT04061161