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 @ 12:12 PM
Ignite Modification Date:
2025-12-24 @ 12:12 PM
NCT ID:
NCT01832961
Eligibility Criteria:
Inclusion Criteria:
\- patients with COPD meeting the Global Initiative for Obstructive Lung Disease (GOLD) guidelines, with forced expiratory volume in the first second of expiration (FEV1) \<80% predicted, FEV1/FVC ratio \<70% predicted (FVC= forced vital capacity), and total lung capacity (TLC) \>80% predicted), with or without sputum, will be included.
The severity of COPD will be classified according to GOLD criteria:
Stage I: mild FEV1/FVC\<0.70 and FEV1\>80% predicted; Stage II: moderate FEV1/FVC\<0.70 and 50\<FEV1\<80% predicted; Stage III: severe FEV1/FVC\<0.70 and 30\<FEV1\<50% predicted; Stage IV: very severe FEV1/FVC\<0.70 and FEV1\<30% or FEV1\<50% predicted plus chronic respiratory failure,
Exclusion Criteria:
Patients with:
* Upper respiratory tract infection within the previous 28 days
* Treatment with antibiotics within 4 weeks prior the study
* Acute dyspnoea or hemoptysis
* Chest pain or recent history of rib fracture or pneumothorax
* Acute cardiovascular events in the previous 3 months
* Any history or evidence of renal, gastrointestinal or hepatic disease
* Any history and evidence of neuropsychiatric disease
* Alcohol, drug abuse or any other condition associated with poor compliance
* Breast feeding
* Pregnancy
* Other complications that hinder the completion of the tests
* Unable to provide written informed consent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
90 Years
Study:
NCT01832961
Study Brief:
Protocol Section:
NCT01832961