PEP and OPEP Devices in Cystic Fibrosis

March 24, 2023 updated by: National Institute for Tuberculosis and Lung Diseases, Poland

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Poland
    • Małopolska
      • Rabka-Zdrój, Małopolska, Poland, 34-700

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute for Tuberculosis and Lung Diseases, Poland

Investigators

  • Principal Investigator: Jarosław Prusak, National Tuberculosis and Lung Diseases Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2020

Primary Completion (Anticipated)

June 1, 2023

Study Completion (Anticipated)

February 28, 2025

Study Registration Dates

First Submitted

February 15, 2023

First Submitted That Met QC Criteria

March 24, 2023

First Posted (Actual)

April 6, 2023

Study Record Updates

Last Update Posted (Actual)

April 6, 2023

Last Update Submitted That Met QC Criteria

March 24, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NITLD881034

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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