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

NCT ID: NCT06820918

Last Updated: 2025-02-11

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-04
• Study Completion Date: 2026-06-15

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

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Patients with bronchiectasis

Group Type: EXPERIMENTAL

Bottle PEP

Intervention Type: 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

Interventions

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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role: lead

Responsible Party

RICHELDI LUCA

Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Fondazione Policlinico Universitario Agostino Gemelli

Rome, RM, Italy

Countries

Italy

Other Identifiers

6836

Identifier Type: -

Identifier Source: org_study_id