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Active, not recruiting Not applicable

Physiotherapy With Positive Expiratory Pressure (PEP) Bottle in Patients With Bronchiectasis

NCT06820918 · tracked via the Priya Life Science Italy tracker
Phase
Not applicable
Started
2025-02-04
Last updated
2025-02-11

Condition(s) studied

Bronchiectasis Adult

Investigational drug(s) / intervention(s)

Bottle PEP

Bottle 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

Study 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

Sex
ALL
Min age
18 Years
Max age
—
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

Primary outcome measure(s)

  • 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.

Trial sites (1)

FacilityCityRegionStatus
Fondazione Policlinico Universitario Agostino Gemelli Rome RM
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06820918 on ClinicalTrials.gov ↗ ← All trials in Italy