PEP and OPEP Devices in Cystic Fibrosis

Not Applicable

Recruiting

• Conditions: Cystic Fibrosis

• Registration Number: NCT05801952
• Lead Sponsor: National Institute for Tuberculosis and Lung Diseases, Poland

Brief Summary

Cystic fibrosis (CF) is the most common severe autosomal recessive genetic disease in Caucasians. The CFTR (cystic fibrosis transmembrane regulator) gene, which encodes the chloride channel of the epithelial cell membrane, is responsible for the development of the disease. Respiratory physiotherapy, especially bronchial drainage is one of the basic elements of comprehensive management in patients with CF. Among the many procedures used in CF drainage physiotherapy, the most commonly include these using positive expiratory pressure (PEP) and oscillating positive expiratory pressure (OPEP). The aim of the study is to assess the efficacy of the usage of selected PEP and OPEP devices in bronchial drainage in cystic fibrosis patients during exacerbation of the disease.

Detailed Description

The aim of the study is to assess the efficacy of the short-term (4-days) use of selected devices generating positive expiratory pressure (PEP device: PARI PEP® S System) and oscillating positive expiratory pressure (OPEP devices: Aerobika\* OPEP Device and PARI O-PEP Device commonly called: Flutter) in bronchial drainage in cystic fibrosis patients during exacerbation of the disease. Patients will perform bronchial drainage in three different groups using different devices in each of them. The main questions study aims to answer are: 1. Whether the devices used are effective in bronchial drainage in patients with cystic fibrosis, 2. Are there differences in efficiency between the devices used.

Study Timeline

• Study Start: 2020-01-01
• Study First Submitted: 2023-02-15
• Status Verified: 2023-03
• Study First Submitted QC: 2023-03-24
• Last Update Submitted: 2023-03-24
• Study First Posted: 2023-04-06
• Last Update Posted: 2023-04-06
• Primary Completion: 2023-06
• Study Completion: 2025-02-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• written consent of the patient and/or guardian, age over 12, no disease complications (within the last 2 months) in the form of: active haemoptysis, pneumothorax, chest surgeries, surgical procedures in the area of the esophagus (esophageal varices), otitis media,
• the ability to perform correctly lung function tests and FEV1 value above 20% predicted,
• the presence of respiratory symptoms indicating exacerbation of the disease, i.e. increasing of cough, increasing of dyspnoea, decrease in FEV1 by 10% or more from a previously recorded value.

Exclusion Criteria

• lack of written consent of the patient and/or guardian, age below 12, occurrence of disease complications (within the last 2 months) in the form of: active hemoptysis, pneumothorax, chest surgeries, surgical procedures in the area of the esophagus (esophageal varices), otitis media,
• inability to perform lung function tests, FEV1 value below 20% of predicted value,
• PEP, OPEP device intolerance,
• no symptoms of the respiratory system indicating exacerbation of the disease, i.e. increasing of cough, increasing of dyspnoea, decrease in in FEV1 less than 10% from a previously recorded value.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pulmonary Function. Measured indicators: FEV1, FVC	Baseline and the day 4	Volume measurement (L). Change from baseline to day 4
Sputum expectorated	from the 1st to the 4th day	Volume measurement (ml)
Pulmonary Function. Measured indicators: FEF75	Baseline and the day 4	Volume and flow measurement (L/s). Change from baseline to day 4

Trial Locations

Locations (1)

National Tuberculosis and Lung Diseases Research Institute; 🇵🇱 Rabka-Zdrój, Małopolska, Poland