PEP and OPEP Devices in Cystic Fibrosis

NCT05801952 | Unknown DMC

• 1 other identifier: NITLD881034
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Cystic Fibrosis

Keywords

Cystic Fibrosis; PEP; OPEP

Outcome Measures

Primary Outcomes (3)

• Pulmonary Function. Measured indicators: FEV1, FVC

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

  Baseline and the day 4

• Pulmonary Function. Measured indicators: FEF75

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

  Baseline and the day 4

• Sputum expectorated

  Volume measurement (ml)

  from the 1st to the 4th day

Study Arms (3)

Aerobika OPEP Therapy

EXPERIMENTAL

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

Flutter O-PEP Therapy

EXPERIMENTAL

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

PEP Therapy

EXPERIMENTAL

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

Interventions

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

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.).

Also known as: 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

Aerobika OPEP Therapy; Flutter O-PEP Therapy; PEP Therapy

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute for Tuberculosis and Lung Diseases, Poland: lead

Study Sites (1)

National Tuberculosis and Lung Diseases Research Institute

Rabka-Zdrój, Małopolska, 34-700, Poland

RECRUITING

Related 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.

  PMID: 7675553 BACKGROUND

• 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.

  PMID: 31735561 RESULT

• 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.

  PMID: 28471492 RESULT

• 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.

  PMID: 1628733 RESULT

• 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.

  PMID: 30670668 RESULT

• 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.

  PMID: 28292973 RESULT

• 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.

  PMID: 30774739 RESULT

• 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.

  PMID: 32581531 RESULT

• 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.

  PMID: 12004158 RESULT

• 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.

  PMID: 9554641 RESULT

• 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.

  PMID: 7809441 RESULT

• 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.

  PMID: 15065835 RESULT

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Study Officials

• Jarosław Prusak

  National Tuberculosis and Lung Diseases Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jarosław Prusak

CONTACT

+48182676060; jprusak@igrabka.edu.pl

Katarzyna Warzeszak

CONTACT

+48182676060; kwarzeszak@igrabka.edu.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 15, 2023
• First Posted: April 6, 2023
• Study Start: January 1, 2020
• Primary Completion: June 1, 2023
• Study Completion: February 28, 2025
• Last Updated: April 6, 2023

Record last verified: 2023-03

Locations

PL (1)