PEP and O-PEP Device for Nebulization in Cystic Fibrosis

National Institute for Tuberculosis and Lung Diseases, Poland

Status: Active, not recruiting

Conditions: Cystic Fibrosis

Treatments: Device: Nebulization with Pari LC Sprint; Device: Nebulization with OPEP device; Device: Nebulization with PEP device

Study type: Interventional

Funder types: Other

Identifiers

NCT06964074

NITLD892510

Details and patient eligibility

About

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.

Full 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 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?

Enrollment: 70 estimated patients

Sex: All

Ages: 10+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 3 patient groups

Aerobika with hypertonic saline nebulization

Experimental group

Description:

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.

Treatment:

Device: Nebulization with OPEP device

PEP with hypertonic saline nebulization

Experimental group

Description:

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.

Treatment:

Device: Nebulization with PEP device

hypertonic saline nebulization control group

Experimental group

Description:

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..

Treatment:

Device: Nebulization with Pari LC Sprint