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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Institute for Tuberculosis and Lung Diseases, Poland

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 28, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 15, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 24, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 6, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 6, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 24, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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