Status:
ACTIVE_NOT_RECRUITING
PEP and O-PEP Device for Nebulization in Cystic Fibrosis
Lead Sponsor:
National Institute for Tuberculosis and Lung Diseases, Poland
Conditions:
Cystic Fibrosis
Eligibility:
All Genders
10+ years
Phase:
NA
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 regular...
Detailed Description
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 nebuli...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT06964074
Start Date
January 1 2022
End Date
December 1 2025
Last Update
May 9 2025
Active Locations (2)
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1
National Tuberculosis and Lung Diseases Research Institute
Rabka-Zdrój, Malopolska, Poland, 34-700
2
National Institute Tuberculosis and Lung Diesases
Rabka-Zdrój, Małopolska, Poland, 34-700