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

Not Applicable

Active, not recruiting

• Conditions: Bronchiectasis Adult

• Registration Number: NCT06820918
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-02
• Study Start: 2025-02-04
• Study First Submitted: 2025-02-04
• Study First Submitted QC: 2025-02-10
• Last Update Submitted: 2025-02-10
• Study First Posted: 2025-02-11
• Last Update Posted: 2025-02-11
• Primary Completion: 2026-02-15
• Study Completion: 2026-06-15

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
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 Locations

Locations (1)

Fondazione Policlinico Universitario Agostino Gemelli; 🇮🇹 Rome, RM, Italy