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Active, Not Recruiting

NCT Number: NCT06964074

PEP and O-PEP Device for Nebulization in Cystic Fibrosis

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

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

Age range

10 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Tuberculosis and Lung Diseases Research Institute, Rabka-Zdrój, Malopolska, Poland

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About this study

The study aims to determine whether the addition of devices with positive expiratory pressure (Pari PEP System S) or positive pressure with oscillation (Aerobika) assists with hypertonic saline nebulization in patients with cystic fibrosis exacerbation. The study assesses whether these devices facilitate the easier evacuation of retained secretions, shorten bronchial drainage time, and improve pulmonary function test results. Participants are randomly assigned to specific groups (Group I - inhalation with O-PEP, Group II - inhalation with PEP, Group III - control group, standard inhalation) using a calendar formula (day of the month divided by 3). Each group performs bronchial drainage following the same protocol: autogenic drainage and a device with positive variable expiratory pressure (device name: Pari O-PEP).

The main questions the study aims to answer are: 1. Does implementing inhalation devices improve functional test indicators and the amount of mucus expectorated during inhalation? 2. Are there differences in effectiveness between the groups?

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

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.

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.

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.

Primary outcomes

  1. 1. Pulmonary Function Test (PFT)

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

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

  2. 1. Pulmonary Function Test (PFT)

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

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

  3. 1.2 Pulmonary Function Test (PFT)

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

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

  4. Survey Cystic Fibrosis Questionnaire-Revised (CFQ-R)

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

    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.

Other outcomes

  1. Sputum expectorated.

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

    Volume measurement [ml], during inhalation and during physiotherapy.

Sponsors and collaborators

Lead sponsor

National Institute for Tuberculosis and Lung Diseases, Poland

Other

Registry information

Official study title

The Addition of a PEP or O-PEP Device to Nebulization With Hypertonic Saline in Patients With Cystic Fibrosis During Exacerbation

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
May 9, 2025
Registry last updated
May 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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