PEP and OPEP Devices in Cystic Fibrosis

Cystic Fibrosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05801952
• Other study ID #: NITLD881034
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: February 28, 2025

Study information

• Verified date: March 2023
• Source: National Institute for Tuberculosis and Lung Diseases, Poland
• Contact: Jaroslaw Prusak
• Phone: +48182676060
• Email: jprusak[@]igrabka.edu.pl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: February 28, 2025
• Est. primary completion date: June 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

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.).

Locations

Country	Name	City	State
Poland	National Tuberculosis and Lung Diseases Research Institute	Rabka-Zdrój	Malopolska

Sponsors (1)

Lead Sponsor	Collaborator
National Institute for Tuberculosis and Lung Diseases, Poland

Country where clinical trial is conducted

Poland, 

References & Publications (12)

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. — View 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. — View 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 Fib — View 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. — View 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. — View 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 Chro — View 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. — View 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. — View 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. — View 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: — View 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;2019:917 — View 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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

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