Bronchiectasis Adult
Conditions
Brief summary
The aim of this study is to determine whether respiratory physiotherapy using the Positive Expiratory Pressure (PEP) bottle has an effect on respiratory function, measured through spirometry, in patients with a diagnosis of bronchiectasis not associated with cystic fibrosis.
Interventions
DEVICEBottle PEP
Home respiratory physiotherapy using the PEP bottle for a minimum of 10 minutes to a maximum of 30 minutes, twice a day (morning and evening), every day for 30 days
Sponsors
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the effect of respiratory physiotherapy using a PEP bottle on respiratory function through the measurement of FEV1 (Forced Expiratory Volume in the 1st second) | 60 days | To evaluate the effect of respiratory physiotherapy using the PEP bottle on respiratory function in patients with a diagnosis of bronchiectasis not associated with cystic fibrosis. |
Countries
Italy
Outcome results
None listed