PEP and O-PEP Device for Nebulization in Cystic Fibrosis

NCT06964074 | Active Not Recruiting DMC

• 1 other identifier: NITLD892510
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 2

Brief Summary

Physiotherapy is an essential element in the comprehensive treatment of patients with cystic fibrosis. In symptomatic individuals, from a respiratory system perspective, it should be performed regularly, as it directly contributes to slowing disease progression. Even though patients perform airway-clearing physical therapy daily, it should be intensified during exacerbations. Although solutions for effectively clearing the airways have been sought for many years, there is still no leading technique for removing secretions from the respiratory tract. Modifications during inhalation aimed at thinning and loosening the accumulated thick mucus can facilitate the effective mobilization and expectoration of secretions, thus improving patients' quality of life.

Conditions

Cystic Fibrosis

Keywords

cystic fibrosis; exacerbations; chest physiotherapy; PEP device; O-PEP device

Outcome Measures

Primary Outcomes (4)

• 1. Pulmonary Function Test (PFT)

  Measured indicators: Bodyplethysmographie: FEV1, FVC, volume measurement (L). Change from baseline during hospitalization (at least 8 days).

  From baseline to study completion, the average duration is 10 days.

• 1. Pulmonary Function Test (PFT)

  Measured indicators: Bodyplethysmographie: MEF 50, flow measurement (l/s). Change from baseline during hospitalization (at least 8 days).

  From baseline to study completion, the average duration is 10 days.

• 1.2 Pulmonary Function Test (PFT)

  Measured indicators: Impulse Oscillometry, IOS: R20, R5 kilopaskal per litre per second (kPa/l/s). Change from baseline during hospitalization (at least 8 days).

  From baseline to study completion, the average duration is 10 days.

• Survey Cystic Fibrosis Questionnaire-Revised (CFQ-R)

  A survey assessing the quality of life, dedicated to people with cystic fibrosis. The survey includes questions on: physical, vitality, emotion, eat, treatment burden, health perception, social, body, role, weight, respiratory, digestion. The survey is intended for people with cystic fibrosis and their parents from 6 years of age. Interpretion: a score scale scale title: Manual scoring for the Cystic Fibrosis Questionnaire-Revised (CFQ-R), Teen/adult: Minimum values 1 Maximum values 196, Parents: Minimum values 1 Maximum values 157, Child 12 to 13: minumum values 1 maximum values 128, Child 6 to 11: minumum values 1 maximum values 128.

  From baseline to study completion, the average duration is 10 days.

Other Outcomes (1)

• Sputum expectorated.

  From baseline to study completion, the average duration is 10 days.

Study Arms (3)

Aerobika with hypertonic saline nebulization

EXPERIMENTAL

Inhalation involves breathing through the device Aerobika with the dedicated AeroEclipse XL BAN nebulizer. The level of expiratory resistance is adjusted individually. The pressure ranges from 5 to 20 cm H2O, and the oscillation frequency is approximately 15 Hz. The inhalation duration is 10 minutes. The program duration is 10 days. The frequency is twice a day.

Device: Nebulization with OPEP device

PEP with hypertonic saline nebulization

EXPERIMENTAL

Inhalation using the PARI PEP® S System involves breathing through the device with the dedicated Pari LC Sprint nebulizer. The level of expiratory resistance is adjusted individually. The pressure in the mid-expiratory range is 10-20 cmH2O. The inhalation duration is 10 minutes. The program duration is 10 days. The frequency is twice a day.

Device: Nebulization with PEP device

hypertonic saline nebulization control group

EXPERIMENTAL

Inhalation with a hypertonic saline solution using a Pari LC Sprint nebulizer with a mouthpiece and nasal clip. The inhalation duration is 10 minutes. The program duration is 10 days. The frequency is twice a day..

Device: Nebulization with Pari LC Sprint

Interventions

Nebulization with OPEP device DEVICE

During hospitalization due to exacerbation of the bronchopulmonary disease, patients performed inhalations twice a day using one of two devices: "PARI PEP® S System" (produced by PARI, Germany) with a dedicated Pari LC Sprint nebulizer or the "Aerobika\*OPEP Device" (produced by TRUDELL MEDICAL INTERNATIONAL) with a dedicated Aero Eclipse XL nebulizer, or they were in the control group where they performed inhalations in the standard way using the Pari LC Sprint nebulizer (produced by PARI, Germany). Frequency: twice daily. Inhalation duration: 10 minutes. Immediately after inhalation, each patient performed physiotherapy in the same scheme using the "Pari OPEP" device, 15 exhalations, and autogenic drainage technique according to the method's concept, with the drainage duration ranging from 15 to 30 minutes.

Aerobika with hypertonic saline nebulization

Nebulization with PEP device DEVICE

During hospitalization due to exacerbation of the bronchopulmonary disease, patients performed inhalations twice a day using one of two devices: "PARI PEP® S System" (produced by PARI, Germany) with a dedicated Pari LC Sprint nebulizer or the "Aerobika\*OPEP Device" (produced by TRUDELL MEDICAL INTERNATIONAL) with a dedicated Aero Eclipse XL nebulizer, or they were in the control group where they performed inhalations in the standard way using the Pari LC Sprint nebulizer (produced by PARI, Germany). Frequency: twice daily. Inhalation duration: 10 minutes. Immediately after inhalation, each patient performed physiotherapy in the same scheme using the "Pari OPEP" device, 15 exhalations, and autogenic drainage technique according to the method's concept, with the drainage duration ranging from 15 to 30 minutes.

PEP with hypertonic saline nebulization

Nebulization with Pari LC Sprint DEVICE

During hospitalization due to exacerbation of the bronchopulmonary disease, patients performed inhalations twice a day using one of two devices: "PARI PEP® S System" (produced by PARI, Germany) with a dedicated Pari LC Sprint nebulizer or the "Aerobika\*OPEP Device" (produced by TRUDELL MEDICAL INTERNATIONAL) with a dedicated Aero Eclipse XL nebulizer, or they were in the control group where they performed inhalations in the standard way using the Pari LC Sprint nebulizer (produced by PARI, Germany). Frequency: twice daily. Inhalation duration: 10 minutes. Immediately after inhalation, each patient performed physiotherapy in the same scheme using the "Pari OPEP" device, 15 exhalations, and autogenic drainage technique according to the method's concept, with the drainage duration ranging from 15 to 30 minutes.

hypertonic saline nebulization control group

Eligibility Criteria

• Age: 10 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,
• no disease complications (within the last 2 months) in the form of: active haemoptysis, chest surgeries, surgical procedures in the area of the esophagus (esophageal varices), otitis media,
• Age above 10 years,
• 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 for the study
• Hemoptysis within the last 2 months
• History of pneumothorax
• Current otitis media
• Age below 10 years
• FEV1 value below 20% of the predicted value
• Surgical procedures in the area of the oesophagus (esophageal varices)
• Intolerance to the PEP or O-PEP device

Sponsors & Collaborators

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

Study Sites (2)

National Tuberculosis and Lung Diseases Research Institute

Rabka-Zdrój, Malopolska, 34-700, Poland

Location

National Institute Tuberculosis and Lung Diesases

Rabka-Zdrój, Małopolska, 34-700, Poland

Location

Related Publications (5)

• Murray MP, Pentland JL, Turnbull K, MacQuarrie S, Hill AT. Sputum colour: a useful clinical tool in non-cystic fibrosis bronchiectasis. Eur Respir J. 2009 Aug;34(2):361-4. doi: 10.1183/09031936.00163208.

  PMID: 19648517 BACKGROUND

• San Miguel-Pagola M, Reychler G, Cebria I Iranzo MA, Gomez-Romero M, Diaz-Gutierrez F, Herrero-Cortina B. Impact of hypertonic saline nebulisation combined with oscillatory positive expiratory pressure on sputum expectoration and related symptoms in cystic fibrosis: a randomised crossover trial. Physiotherapy. 2020 Jun;107:243-251. doi: 10.1016/j.physio.2019.11.001. Epub 2019 Nov 11.

  PMID: 32026826 BACKGROUND

• Orlik T, Sands D. Application of positive expiratory pressure *PEP* in cystic fibrosis patient inhalations. Dev Period Med. 2015 Jan-Mar;19(1):50-9.

  PMID: 26003070 BACKGROUND

• Berlinski A. In vitro evaluation of positive expiratory pressure devices attached to nebulizers. Respir Care. 2014 Feb;59(2):216-22. doi: 10.4187/respcare.02698. Epub 2013 Aug 6.

  PMID: 23920213 BACKGROUND

• 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 BACKGROUND

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

• Katarzyna Warzeszak

  National Tuberculosis and Lung Diseases Research Institute

  PRINCIPAL INVESTIGATOR

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 physiotherapy program involves: Firstly, performing inhalations with hypertonic saline using one of two devices (Aerobika\*OPEP with AeroEclipse XL BAN nebulizer, PARI PEP® S System with Pari LC Sprint nebulizer). The third group serves as the control group and performs inhalations using the Pari LC Sprint nebulizer. After the inhalation, participants record the amount of sputum expectorated during the inhalation and note the color of the sputum. Secondly, immediately after the hypertonic saline inhalation, participants use physiotherapy focused on airway clearance with the Pari O-PEP Flutter device and perform autogenic drainage for 15 breaths in one cycle. Frequency: twice a day. This cycle is repeated twice. The maximum number of cycles is five, depending on the need. Duration: 15-30 minutes. After the physiotherapy, participants also recorded the amount of expectorated secretion and noted the color of the sputum.

Study Record Dates

• First Submitted: March 17, 2025
• First Posted: May 9, 2025
• Study Start: January 1, 2022
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: May 9, 2025

Record last verified: 2025-04

Locations

PL (2)