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PEP and OPEP Devices in Cystic Fibrosis

Primary Purpose

Cystic Fibrosis

Status

Recruiting

Phase

Not Applicable

Locations

Poland

Study Type

Interventional

Intervention

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

About this trial

This is an interventional treatment trial for Cystic Fibrosis focused on measuring Cystic Fibrosis, PEP, OPEP

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

National Tuberculosis and Lung Diseases Research InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Aerobika OPEP Therapy

Flutter O-PEP Therapy

PEP Therapy

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Pulmonary Function. Measured indicators: FEV1, FVC

Volume measurement (L). Change from baseline to day 4

Pulmonary Function. Measured indicators: FEF75

Volume and flow measurement (L/s). Change from baseline to day 4

Sputum expectorated

Volume measurement (ml)

Secondary Outcome Measures

Full Information

NCT ID

NCT05801952

First Posted

February 15, 2023

Last Updated

March 24, 2023

Sponsor

National Institute for Tuberculosis and Lung Diseases, Poland

1. Study Identification

Unique Protocol Identification Number

NCT05801952

Brief Title

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

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Recruiting

Study Start Date

January 1, 2020 (Actual)

Primary Completion Date

June 2023 (Anticipated)

Study Completion Date

February 28, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

National Institute for Tuberculosis and Lung Diseases, Poland

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cystic Fibrosis

Keywords

Cystic Fibrosis, PEP, OPEP

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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.

Masking

None (Open Label)

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Aerobika OPEP Therapy

Arm Type

Experimental

Arm Description

Arm Title

Flutter O-PEP Therapy

Arm Type

Experimental

Arm Description

Arm Title

PEP Therapy

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

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

Other Intervention Name(s)

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

Intervention Description

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.).

Primary Outcome Measure Information:

Title

Pulmonary Function. Measured indicators: FEV1, FVC

Description

Volume measurement (L). Change from baseline to day 4

Time Frame

Baseline and the day 4

Title

Pulmonary Function. Measured indicators: FEF75

Description

Volume and flow measurement (L/s). Change from baseline to day 4

Time Frame

Baseline and the day 4

Title

Sputum expectorated

Description

Volume measurement (ml)

Time Frame

from the 1st to the 4th day

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jarosław Prusak

Phone

+48182676060

Ext

260

jprusak@igrabka.edu.pl

First Name & Middle Initial & Last Name or Official Title & Degree

Katarzyna Warzeszak

Phone

+48182676060

Ext

470

kwarzeszak@igrabka.edu.pl

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jarosław Prusak

Organizational Affiliation

National Tuberculosis and Lung Diseases Research Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

National Tuberculosis and Lung Diseases Research Institute

City

Rabka-Zdrój

State/Province

Małopolska

ZIP/Postal Code

34-700

Country

Poland

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Prusak

Phone

+46182676060

Ext

260

jprusak@igrabka.edu.pl

First Name & Middle Initial & Last Name & Degree

Warzeszak

Phone

+48182676060

Ext

470

kwarzeszak@igrabka.edu.pl

12. IPD Sharing Statement

Citations:

PubMed Identifier

7675553

Citation

Braggion C, Cappelletti LM, Cornacchia M, Zanolla L, Mastella G. Short-term effects of three chest physiotherapy regimens in patients hospitalized for pulmonary exacerbations of cystic fibrosis: a cross-over randomized study. Pediatr Pulmonol. 1995 Jan;19(1):16-22. doi: 10.1002/ppul.1950190104.

Results Reference

background

PubMed Identifier

31735561

Citation

Davies G, Rowbotham NJ, Smith S, Elliot ZC, Gathercole K, Rayner O, Leighton PA, Herbert S, Duff AJ, Chandran S, Daniels T, Nash EF, Smyth AR. Characterising burden of treatment in cystic fibrosis to identify priority areas for clinical trials. J Cyst Fibros. 2020 May;19(3):499-502. doi: 10.1016/j.jcf.2019.10.025. Epub 2019 Nov 15.

Results Reference

result

PubMed Identifier

28471492

Citation

Morrison L, Innes S. Oscillating devices for airway clearance in people with cystic fibrosis. Cochrane Database Syst Rev. 2017 May 4;5(5):CD006842. doi: 10.1002/14651858.CD006842.pub4.

Results Reference

result

PubMed Identifier

1628733

Citation

Lannefors L, Wollmer P. Mucus clearance with three chest physiotherapy regimes in cystic fibrosis: a comparison between postural drainage, PEP and physical exercise. Eur Respir J. 1992 Jun;5(6):748-53.

Results Reference

result

PubMed Identifier

30670668

Citation

Franks LJ, Walsh JR, Hall K, Jacuinde G, Yerkovich S, Morris NR. Comparing the Performance Characteristics of Different Positive Expiratory Pressure Devices. Respir Care. 2019 Apr;64(4):434-444. doi: 10.4187/respcare.06410. Epub 2019 Jan 22.

Results Reference

result

PubMed Identifier

28292973

Citation

Van Fleet H, Dunn DK, McNinch NL, Volsko TA. Evaluation of Functional Characteristics of 4 Oscillatory Positive Pressure Devices in a Simulated Cystic Fibrosis Model. Respir Care. 2017 Apr;62(4):451-458. doi: 10.4187/respcare.04570. Epub 2017 Mar 14.

Results Reference

result

PubMed Identifier

30774739

Citation

Thanh NX, Jacobs P, Suggett J, McIvor A, Kaplan A. Cost-Effectiveness of the Aerobika(R) Oscillating Positive Expiratory Pressure Device in the Management of Chronic Obstructive Pulmonary Disease Exacerbations in Canada. Can Respir J. 2019 Jan 10;2019:9176504. doi: 10.1155/2019/9176504. eCollection 2019. Erratum In: Can Respir J. 2019 May 19;2019:5906984.

Results Reference

result

PubMed Identifier

32581531

Citation

Leemans G, Belmans D, Van Holsbeke C, Kushnarev V, Sugget J, Ides K, Vissers D, De Backer W. A Functional Respiratory Imaging Approach to the Effect of an Oscillating Positive Expiratory Pressure Device in Chronic Obstructive Pulmonary Disease. Int J Chron Obstruct Pulmon Dis. 2020 Jun 4;15:1261-1268. doi: 10.2147/COPD.S242191. eCollection 2020.

Results Reference

result

PubMed Identifier

12004158

Citation

Orlik T, Sands D. [Long-term evaluation of effectiveness for selected chest physiotherapy methods used in the treatment of cystic fibrosis]. Med Wieku Rozwoj. 2001 Jul-Sep;5(3):245-57. Polish.

Results Reference

result

PubMed Identifier

9554641

Citation

Scherer TA, Barandun J, Martinez E, Wanner A, Rubin EM. Effect of high-frequency oral airway and chest wall oscillation and conventional chest physical therapy on expectoration in patients with stable cystic fibrosis. Chest. 1998 Apr;113(4):1019-27. doi: 10.1378/chest.113.4.1019.

Results Reference

result

PubMed Identifier

7809441

Citation

Pryor JA, Webber BA, Hodson ME, Warner JO. The Flutter VRP1 as an adjunct to chest physiotherapy in cystic fibrosis. Respir Med. 1994 Oct;88(9):677-81. doi: 10.1016/s0954-6111(05)80066-6.

Results Reference

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PubMed Identifier

15065835

Citation

Chatham K, Ionescu AA, Nixon LS, Shale DJ. A short-term comparison of two methods of sputum expectoration in cystic fibrosis. Eur Respir J. 2004 Mar;23(3):435-9. doi: 10.1183/09031936.04.00084904.

Results Reference

result

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PEP and OPEP Devices in Cystic Fibrosis

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