Clinical trial NCT05801952: PEP and OPEP Devices in Cystic Fibrosis
Official title: Evaluation of the Short-term Use of Selected PEP and OPEP Devices in Cystic Fibrosis Patients During an Exacerbation of the Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cystic Fibrosis
Keywords: Cystic Fibrosis
PEP
OPEP
Lead sponsor: National Institute for Tuberculosis and Lung Diseases, Poland
Sponsor class: OTHER
First posted: 2023-04-06
Enrollment: 60
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The 4-day physiotherapy program consists of performing bronchial drainage using one of the three devices (Aerobika\* OPEP, PARI O-PEP, PARI PEP® S System). Frequency: twice a day. Physiotherapy session consist of breathing through the device for 15 breaths in one cycle, and taking a few (3-5) relaxed exhalations in accordance with the forced exhalation technique (FET). This cycle is repeated at least three times. The maximum number of cycles is five considering the need. Duration: 10 - 20 min.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pulmonary Function. Measured indicators: FEV1, FVC
timeFrame: Baseline and the day 4
measure: Pulmonary Function. Measured indicators: FEF75
timeFrame: Baseline and the day 4
measure: Sputum expectorated
timeFrame: from the 1st to the 4th day
Secondary outcomes:
Other outcomes:
Locations:
city: Rabka-Zdrój
country: Poland
facility: National Tuberculosis and Lung Diseases Research Institute
state: Małopolska
Study officials:
affiliation: National Tuberculosis and Lung Diseases Research Institute
name: Jarosław Prusak
role: PRINCIPAL_INVESTIGATOR
References:
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