Clinical trial NCT06964074: PEP and O-PEP Device for Nebulization in Cystic Fibrosis
Official title: The Addition of a PEP or O-PEP Device to Nebulization With Hypertonic Saline in Patients With Cystic Fibrosis During Exacerbation
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cystic Fibrosis
Keywords: cystic fibrosis
exacerbations
chest physiotherapy
PEP device
O-PEP device
Lead sponsor: National Institute for Tuberculosis and Lung Diseases, Poland
Sponsor class: OTHER
First posted: 2025-05-09
Enrollment: 70
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The physiotherapy program involves:

Firstly, performing inhalations with hypertonic saline using one of two devices (Aerobika\*OPEP with AeroEclipse XL BAN nebulizer, PARI PEP® S System with Pari LC Sprint nebulizer). The third group serves as the control group and performs inhalations using the Pari LC Sprint nebulizer. After the inhalation, participants record the amount of sputum expectorated during the inhalation and note the color of the sputum.

Secondly, immediately after the hypertonic saline inhalation, participants use physiotherapy focused on airway clearance with the Pari O-PEP Flutter device and perform autogenic drainage for 15 breaths in one cycle. Frequency: twice a day. This cycle is repeated twice. The maximum number of cycles is five, depending on the need. Duration: 15-30 minutes. After the physiotherapy, participants also recorded the amount of expectorated secretion and noted the color of the sputum.
Primary purpose: TREATMENT

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 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.

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 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?

Eligibility criteria: 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

Primary outcomes:
measure: 1. Pulmonary Function Test (PFT)
timeFrame: From baseline to study completion, the average duration is 10 days.
measure: 1. Pulmonary Function Test (PFT)
timeFrame: From baseline to study completion, the average duration is 10 days.
measure: 1.2 Pulmonary Function Test (PFT)
timeFrame: From baseline to study completion, the average duration is 10 days.
measure: Survey Cystic Fibrosis Questionnaire-Revised (CFQ-R)
timeFrame: From baseline to study completion, the average duration is 10 days.
Secondary outcomes:
Other outcomes:
measure: Sputum expectorated.
timeFrame: From baseline to study completion, the average duration is 10 days.
Locations:
city: Rabka-Zdrój
country: Poland
facility: National Tuberculosis and Lung Diseases Research Institute
state: Malopolska
city: Rabka-Zdrój
country: Poland
facility: National Institute Tuberculosis and Lung Diesases
state: Małopolska
Study officials:
affiliation: National Tuberculosis and Lung Diseases Research Institute
name: Katarzyna Warzeszak
role: PRINCIPAL_INVESTIGATOR
References:
citation: Murray MP, Pentland JL, Turnbull K, MacQuarrie S, Hill AT. Sputum colour: a useful clinical tool in non-cystic fibrosis bronchiectasis. Eur Respir J. 2009 Aug;34(2):361-4. doi: 10.1183/09031936.00163208.
citation: San Miguel-Pagola M, Reychler G, Cebria I Iranzo MA, Gomez-Romero M, Diaz-Gutierrez F, Herrero-Cortina B. Impact of hypertonic saline nebulisation combined with oscillatory positive expiratory pressure on sputum expectoration and related symptoms in cystic fibrosis: a randomised crossover trial. Physiotherapy. 2020 Jun;107:243-251. doi: 10.1016/j.physio.2019.11.001. Epub 2019 Nov 11.
citation: Orlik T, Sands D. Application of positive expiratory pressure *PEP* in cystic fibrosis patient inhalations. Dev Period Med. 2015 Jan-Mar;19(1):50-9.
citation: Berlinski A. In vitro evaluation of positive expiratory pressure devices attached to nebulizers. Respir Care. 2014 Feb;59(2):216-22. doi: 10.4187/respcare.02698. Epub 2013 Aug 6.
citation: Chatham K, Ionescu AA, Nixon LS, Shale DJ. A short-term comparison of two methods of sputum expectoration in cystic fibrosis. Eur Respir J. 2004 Mar;23(3):435-9. doi: 10.1183/09031936.04.00084904.