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

NCT06820918 | Active Not Recruiting DMC

• 1 other identifier: 6836
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Bronchiectasis Adult

Outcome Measures

Primary Outcomes (1)

• 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)

  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.

  60 days

Study Arms (1)

Patients with bronchiectasis

EXPERIMENTAL

Device: Bottle PEP

Interventions

Bottle PEP DEVICE

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

Patients with bronchiectasis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario Agostino Gemelli

Rome, RM, 00168, Italy

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: February 4, 2025
• First Posted: February 11, 2025
• Study Start: February 4, 2025
• Primary Completion: February 15, 2026
• Study Completion (Estimated): June 15, 2026
• Last Updated: February 11, 2025

Record last verified: 2025-02

Locations

IT (1)