Clinical trial NCT06820918: Physiotherapy With Positive Expiratory Pressure (PEP) Bottle in Patients With Bronchiectasis
Official title: Impact of Physiotherapy With Positive Expiratory Pressure (PEP) Bottle on Respiratory Function in Patients With Bronchiectasis (FisioFEV)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Bronchiectasis Adult
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2025-02-11
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: 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)
timeFrame: 60 days
Secondary outcomes:
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli
state: RM
Study officials:
References: