PEP and OPEP Devices in Cystic Fibrosis

Sponsor

National Institute for Tuberculosis and Lung Diseases, Poland (Other)

Overall Status

Recruiting

CT.gov ID

NCT05801952

Collaborator

(none)

Enrollment

Location

Arms

61.9

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cystic Fibrosis	Device: Aerobika* OPEP, PARI O-PEP (Flutter), PARI PEP® S System	N/A

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:

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 Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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.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.

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Evaluation of the Short-term Use of Selected PEP and OPEP Devices in Cystic Fibrosis Patients During an Exacerbation of the Disease

Actual Study Start Date :

Jan 1, 2020

Anticipated Primary Completion Date :

Jun 1, 2023

Anticipated Study Completion Date :

Feb 28, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Aerobika OPEP Therapy Bronchial drainage session with the Aerobika OPEP device 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. This cycle is repeated at least three times. The maximum number of cycles is five considering the need. The size of the applied expiratory resistance is selected individually. The pressure is 5 - 20 cm H2O and the oscillation frequency is up to about 15 Hz. Duration of the session: 10 - 20 min. Duration of the program: 4 days. Frequency: twice a day.	Device: *Aerobika OPEP, PARI O-PEP (Flutter), PARI PEP® S System** The 4-day physiotherapy program consists of performing bronchial drainage using one of the three devices: Aerobika* OPEP Device (Trudell Medical International), Flutter - PARI O-PEP Device (PARI Respiratory Equipment, Inc.) and PEP - PARI PEP® S System (PARI Respiratory Equipment, Inc.). Other Names: Aerobika* OPEP, Primary Device ID: 62860110504023 PARI O-PEP, Part Number: 018F65, NDC: 83490-0180-14 PARI PEP® S System, Part Number: 018F63, NDC: 83490-0180-12
Experimental: Flutter O-PEP Therapy Bronchial drainage session with the Flutter O-PEP device 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. This cycle is repeated at least three times. The maximum number of cycles is five considering the need. The size of the applied expiratory resistance is selected individually. The pressure is 5 - 20 cm H2O and the oscillation frequency is up to about 15 Hz. Duration of the session: 10 - 20 min. Duration of the program: 4 days. Frequency: twice a day.	Device: *Aerobika OPEP, PARI O-PEP (Flutter), PARI PEP® S System** The 4-day physiotherapy program consists of performing bronchial drainage using one of the three devices: Aerobika* OPEP Device (Trudell Medical International), Flutter - PARI O-PEP Device (PARI Respiratory Equipment, Inc.) and PEP - PARI PEP® S System (PARI Respiratory Equipment, Inc.). Other Names: Aerobika* OPEP, Primary Device ID: 62860110504023 PARI O-PEP, Part Number: 018F65, NDC: 83490-0180-14 PARI PEP® S System, Part Number: 018F63, NDC: 83490-0180-12
Experimental: PEP Therapy Bronchial drainage session with the PEP device 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. This cycle is repeated at least three times. The maximum number of cycles is five considering the need. The size of the applied expiratory resistance is selected individually. The pressure is 10-20 cmH2O during exhalation. Duration of the session: 10 - 20 min. Duration of the program: 4 days. Frequency: twice a day.	Device: *Aerobika OPEP, PARI O-PEP (Flutter), PARI PEP® S System** The 4-day physiotherapy program consists of performing bronchial drainage using one of the three devices: Aerobika* OPEP Device (Trudell Medical International), Flutter - PARI O-PEP Device (PARI Respiratory Equipment, Inc.) and PEP - PARI PEP® S System (PARI Respiratory Equipment, Inc.). Other Names: Aerobika* OPEP, Primary Device ID: 62860110504023 PARI O-PEP, Part Number: 018F65, NDC: 83490-0180-14 PARI PEP® S System, Part Number: 018F63, NDC: 83490-0180-12

Arm

Intervention/Treatment

Experimental: Aerobika OPEP Therapy

Bronchial drainage session with the Aerobika OPEP device 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. This cycle is repeated at least three times. The maximum number of cycles is five considering the need. The size of the applied expiratory resistance is selected individually. The pressure is 5 - 20 cm H2O and the oscillation frequency is up to about 15 Hz. Duration of the session: 10 - 20 min. Duration of the program: 4 days. Frequency: twice a day.

Device: Aerobika* OPEP, PARI O-PEP (Flutter), PARI PEP® S System

The 4-day physiotherapy program consists of performing bronchial drainage using one of the three devices: Aerobika* OPEP Device (Trudell Medical International), Flutter - PARI O-PEP Device (PARI Respiratory Equipment, Inc.) and PEP - PARI PEP® S System (PARI Respiratory Equipment, Inc.).

Other Names:

Aerobika* OPEP, Primary Device ID: 62860110504023

PARI O-PEP, Part Number: 018F65, NDC: 83490-0180-14

PARI PEP® S System, Part Number: 018F63, NDC: 83490-0180-12

Experimental: Flutter O-PEP Therapy

Bronchial drainage session with the Flutter O-PEP device 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. This cycle is repeated at least three times. The maximum number of cycles is five considering the need. The size of the applied expiratory resistance is selected individually. The pressure is 5 - 20 cm H2O and the oscillation frequency is up to about 15 Hz. Duration of the session: 10 - 20 min. Duration of the program: 4 days. Frequency: twice a day.

Device: Aerobika* OPEP, PARI O-PEP (Flutter), PARI PEP® S System

Other Names:

Aerobika* OPEP, Primary Device ID: 62860110504023

PARI O-PEP, Part Number: 018F65, NDC: 83490-0180-14

PARI PEP® S System, Part Number: 018F63, NDC: 83490-0180-12

Experimental: PEP Therapy

Bronchial drainage session with the PEP device 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. This cycle is repeated at least three times. The maximum number of cycles is five considering the need. The size of the applied expiratory resistance is selected individually. The pressure is 10-20 cmH2O during exhalation. Duration of the session: 10 - 20 min. Duration of the program: 4 days. Frequency: twice a day.

Device: Aerobika* OPEP, PARI O-PEP (Flutter), PARI PEP® S System

Other Names:

Aerobika* OPEP, Primary Device ID: 62860110504023

PARI O-PEP, Part Number: 018F65, NDC: 83490-0180-14

PARI PEP® S System, Part Number: 018F63, NDC: 83490-0180-12

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.