PEP and O-PEP Device for Nebulization in Cystic Fibrosis

NAActive, not recruitingINTERVENTIONAL
Enrollment

70

Participants

Timeline

Start Date

January 1, 2022

Primary Completion Date

December 1, 2025

Study Completion Date

December 1, 2025

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."

Trial Locations (2)

34-700

National Tuberculosis and Lung Diseases Research Institute, Rabka-Zdrój

National Institute Tuberculosis and Lung Diesases, Rabka-Zdrój

All Listed Sponsors
lead

National Institute for Tuberculosis and Lung Diseases, Poland

OTHER