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:
2025-12-25 @ 4:55 AM
Ignite Modification Date:
2025-12-25 @ 4:55 AM
NCT ID:
NCT06820918
Eligibility Criteria:
Inclusion Criteria:
* Subject over 18 years of age
* Confirmed diagnosis of bronchiectasis based on high-resolution chest CT, showing bronchial dilation according to one or more of the following radiological criteria in accordance with the 2019 BTS guidelines.
* Ratio between the internal lumen of the bronchus and the adjacent pulmonary artery \>1
* Absence of normal bronchial tapering
* Visibility of the airways within 1 cm from the pleura
* Subject with chronic bronchial hypersecretion (daily secretion ≥ 15ml)
* Patients capable of performing physiotherapy using the PEP bottle
* Patients capable of performing global spirometry
Exclusion Criteria:
* Subject already undergoing regular respiratory physiotherapy
* Subject without significant bronchial hypersecretion
* Concomitant diagnosis of Cystic Fibrosis, Primary Ciliary Dyskinesia, NTM-PD, TB, Sarcoidosis, Active Neoplasia
* Diagnosis of Asthma according to the 2023 GINA guidelines, defined as documented excessive variability in pulmonary function (positive bronchodilation or bronchoprovocation test with methacholine, or diurnal variability of PEF) + documented limitation of expiratory airflow.
* Diagnosis of COPD according to the 2023 GOLD guidelines, defined as FEV/FVC post-bronchodilation \<0.7 on forced spirometry in the presence of suggestive symptoms (dyspnea, chronic cough, sputum production) and/or exposure to risk factors for the disease (e.g., cigarette smoking).
* Contraindications to PEP-Bottle Physiotherapy (Pneumothorax; Hemoptysis; Myocardial infarction in the 4 weeks prior to informed consent signature)
* Exacerbation of disease in the previous 4 weeks
* Use of inhalation therapy in the 4 weeks prior to informed consent signature
* Active smoker
* Subject undergoing non-invasive ventilation or with a tracheostomy
* Inability to provide informed consent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06820918
Study Brief:
Protocol Section:
NCT06820918