PEP and O-PEP Device for Nebulization in Cystic Fibrosis

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

Interventions

DEVICE

Nebulization with OPEP 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.

DEVICE

Nebulization with PEP 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.

DEVICE

Nebulization with Pari LC Sprint

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.

Sponsors & Collaborators

• National Institute for Tuberculosis and Lung Diseases, Poland

  lead OTHER

Principal Investigators

• Katarzyna Warzeszak · National Tuberculosis and Lung Diseases Research Institute

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

10 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-01-01

Primary Completion

2025-12-01

Completion

2025-12-01

Countries

• Poland

Study Locations