Physiotherapy With Positive Expiratory Pressure (PEP) Bot... | NCT06820918

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

NCT06820918

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Status

Active, not recruiting

Last Update Posted

Feb 11, 2025Actual

Enrollment

30Estimated

Phase

Not Applicable

Conditions

Bronchiectasis Adult

Interventions

Bottle PEP

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2025

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 4, 2025Actual

Primary Completion Date

Feb 15, 2026Estimated

Completion Date

Jun 15, 2026Estimated

First Submitted Date

Feb 4, 2025

First Submission Date that Met QC Criteria

Feb 10, 2025

First Posted Date

Feb 11, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 10, 2025

Last Update Posted Date

Feb 11, 2025Actual

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Label	Type	Description	Intervention Names
Patients with bronchiectasis	Experimental		Device: Bottle PEP

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided