Cystic FibrosisNCT06964074
PEP and O-PEP Device for Nebulization in Cystic Fibrosis
A study testing Nebulization with OPEP device, Nebulization with PEP device and Nebulization with Pari LC Sprint in people with Cystic Fibrosis, run by National Institute for Tuberculosis and Lung Diseases, Poland at 2 sites in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 years and older
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Nebulization with OPEP device, Nebulization with PEP device and Nebulization with Pari LC Sprint
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 2 sitesPoland
- Study dates
- 1 Jan 2022to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
Poland2 sites
National Tuberculosis and Lung Diseases Research Institute
Rabka-Zdrój, Malopolska, 34-700
National Institute Tuberculosis and Lung Diesases
Rabka-Zdrój, Małopolska, 34-700
About this study
Official title: The Addition of a PEP or O-PEP Device to Nebulization With Hypertonic Saline in Patients With Cystic Fibrosis During Exacerbation
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.
Read the 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?
- Conditions
- Cystic Fibrosis
- Being tested
- Nebulization with OPEP device, Nebulization with PEP device, Nebulization with Pari LC Sprint
- Keywords
- cystic fibrosis, exacerbations, chest physiotherapy, PEP device, O-PEP device
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nebulization with OPEP deviceDevice
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.
Nebulization with PEP deviceDevice
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.
Nebulization with Pari LC SprintDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Aerobika with hypertonic saline nebulization | Experimental | 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. Receives: Device: Nebulization with OPEP device |
| PEP with hypertonic saline nebulization | Experimental | 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. Receives: Device: Nebulization with PEP device |
| hypertonic saline nebulization control group | Experimental | 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.. Receives: Device: Nebulization with Pari LC Sprint |
What is being measured
The primary outcome is the main question the study is designed to answer.
1. Pulmonary Function Test (PFT)
Measured indicators: Bodyplethysmographie: FEV1, FVC, volume measurement (L). Change from baseline during hospitalization (at least 8 days).
Measured: From baseline to study completion, the average duration is 10 days.
1. Pulmonary Function Test (PFT)
Measured indicators: Bodyplethysmographie: MEF 50, flow measurement (l/s). Change from baseline during hospitalization (at least 8 days).
Measured: From baseline to study completion, the average duration is 10 days.
1.2 Pulmonary Function Test (PFT)
Measured indicators: Impulse Oscillometry, IOS: R20, R5 kilopaskal per litre per second (kPa/l/s). Change from baseline during hospitalization (at least 8 days).
Measured: From baseline to study completion, the average duration is 10 days.
Survey Cystic Fibrosis Questionnaire-Revised (CFQ-R)
A survey assessing the quality of life, dedicated to people with cystic fibrosis. The survey includes questions on: physical, vitality, emotion, eat, treatment burden, health perception, social, body, role, weight, respiratory, digestion. The survey is intended for people with cystic fibrosis and their parents from 6 years of age. Interpretion: a score scale scale title: Manual scoring for the Cystic Fibrosis Questionnaire-Revised (CFQ-R), Teen/adult: Minimum values 1 Maximum values 196, Parents: Minimum values 1 Maximum values 157, Child 12 to 13: minumum values 1 maximum values 128, Child 6 to 11: minumum values 1 maximum values 128.
Measured: From baseline to study completion, the average duration is 10 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2025
- Study start1 Jan 2022
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute for Tuberculosis and Lung Diseases, Poland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Katarzyna Warzeszak, Principal investigator, National Tuberculosis and Lung Diseases Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06964074
- Sponsor's protocol ID
- NITLD892510
- Status last verified
- Apr 2025
- First submitted
- 17 Mar 2025
- Last updated
- 9 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 19648517San 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.
PubMed 32026826Orlik T, Sands D. Application of positive expiratory pressure *PEP* in cystic fibrosis patient inhalations. Dev Period Med. 2015 Jan-Mar;19(1):50-9.
PubMed 26003070Berlinski 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.
PubMed 23920213Chatham 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.
PubMed 15065835
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Addition of a PEP or O-PEP Device to Nebulization With Hypertonic Saline in Patients With Cystic Fibrosis During Exacerbation
- ClinicalTrials.gov ID
- NCT06964074
- Acronym / sponsor ID
- NITLD892510
- Conditions
- Cystic Fibrosis
- Keywords
- cystic fibrosis, exacerbations, chest physiotherapy, PEP device, O-PEP device
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- National Institute for Tuberculosis and Lung Diseases, PolandUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 9 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Aerobika with hypertonic saline nebulization | Experimental | Device: Nebulization with OPEP deviceInhalation 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. |
| PEP with hypertonic saline nebulization | Experimental | Device: Nebulization with PEP deviceInhalation 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. |
| hypertonic saline nebulization control group | Experimental | Device: Nebulization with Pari LC SprintInhalation 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.. |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- Lack of written consent for the study
- Hemoptysis within the last 2 months
- History of pneumothorax
- Current otitis media
- Age below 10 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nebulization with OPEP deviceDuring 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 | Aerobika with hypertonic saline nebulization |
| Nebulization with PEP deviceDuring 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 | PEP with hypertonic saline nebulization |
| Nebulization with Pari LC SprintDuring 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 | hypertonic saline nebulization control group |
Primary outcome
1. Pulmonary Function Test (PFT)
Time frame: From baseline to study completion, the average duration is 10 days.
Measured indicators: Bodyplethysmographie: FEV1, FVC, volume measurement (L). Change from baseline during hospitalization (at least 8 days).
1. Pulmonary Function Test (PFT)
Time frame: From baseline to study completion, the average duration is 10 days.
Measured indicators: Bodyplethysmographie: MEF 50, flow measurement (l/s). Change from baseline during hospitalization (at least 8 days).
1.2 Pulmonary Function Test (PFT)
Time frame: From baseline to study completion, the average duration is 10 days.
Measured indicators: Impulse Oscillometry, IOS: R20, R5 kilopaskal per litre per second (kPa/l/s). Change from baseline during hospitalization (at least 8 days).
Survey Cystic Fibrosis Questionnaire-Revised (CFQ-R)
Time frame: From baseline to study completion, the average duration is 10 days.
A survey assessing the quality of life, dedicated to people with cystic fibrosis. The survey includes questions on: physical, vitality, emotion, eat, treatment burden, health perception, social, body, role, weight, respiratory, digestion. The survey is intended for people with cystic fibrosis and their parents from 6 years of age. Interpretion: a score scale scale title: Manual scoring for the Cystic Fibrosis Questionnaire-Revised (CFQ-R), Teen/adult: Minimum values 1 Maximum values 196, Parents: Minimum values 1 Maximum values 157, Child 12 to 13: minumum values 1 maximum values 128, Child 6 to 11: minumum values 1 maximum values 128.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2025.
- Background: PubMed 19648517Murray 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.
- Background: PubMed 32026826San 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.
- Background: PubMed 26003070Orlik T, Sands D. Application of positive expiratory pressure *PEP* in cystic fibrosis patient inhalations. Dev Period Med. 2015 Jan-Mar;19(1):50-9.
- Background: PubMed 23920213Berlinski 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.
- Background: PubMed 15065835Chatham 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katarzyna Warzeszak principal investigator
National Tuberculosis and Lung Diseases Research Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nebulization with OPEP device, Nebulization with PEP device and Nebulization with Pari LC Sprint in people with Cystic Fibrosis, run by National Institute for Tuberculosis and Lung Diseases, Poland at 2 sites in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 9 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1. Pulmonary Function Test (PFT) (time frame: From baseline to study completion, the average duration is 10 days.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06964074, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2025.