NCT06964074Active, not recruiting
PEP and O-PEP Device for Nebulization in Cystic Fibrosis
The Addition of a PEP or O-PEP Device to Nebulization With Hypertonic Saline in Patients With Cystic Fibrosis During Exacerbation
Source: ClinicalTrials.gov · Last updated 9 May 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 70 (estimated)
- First submitted
- 17 Mar 2025
- Start date
- 1 Jan 2022
- Primary completion date
- 1 Dec 2025
- Lead sponsor
- National Institute for Tuberculosis and Lung Diseases, Poland
- Diseases
- Cystic fibrosis
- NCT number
- NCT06964074
What you commit to
- Study type: Interventional
- Planned participants: 70
- From 1 Jan 2022 to the primary completion date, 1 Dec 2025
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Surgical procedures in the area of the oesophagus (esophageal varices)
Other illness
- History of pneumothorax
Age
- Age below 10 years
Other
- Lack of written consent for the study
- Hemoptysis within the last 2 months
- Current otitis media
- FEV1 value below 20% of the predicted value
- Intolerance to the PEP or O-PEP device
Who the study is looking for
- 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.
Age in the registry: 10 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| National Institute Tuberculosis and Lung Diesases Coordinator of this site? Confirm its status | Rabka-Zdrój | Poland | Unknown status |
| National Tuberculosis and Lung Diseases Research Institute Coordinator of this site? Confirm its status | Rabka-Zdrój | Poland | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.