Cystic FibrosisNCT04961008
Bottle PEP in Cystic Fibrosis
A study testing Bottle-PEP and Routine physiotherapy in people with Cystic Fibrosis, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
The study aims to investigate the sustainability of Bottle-PEP in patients with cystic fibrosis Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Bottle-PEP and Routine physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2019to 31 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Diagnosis of cystic fibrosis
- Acute exacerbation
Who cannot join
- Any contraindication using the Bottle - PEP such as the presence of pneumothorax
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Marmara University School of Medicine Department of Physical Medicine and Rehabilitation
Istanbul, 34899
About this study
Official title: Safety and Sustainability in Bottle PEP in Cystic Fibrosis
The study aims to investigate the sustainability of Bottle-PEP in patients with cystic fibrosis
- Conditions
- Cystic Fibrosis
- Being tested
- Bottle-PEP, Routine physiotherapy
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bottle-PEPOther
A device that gives positive pressure from a bottle with the help of a non deflating tube
Routine physiotherapyOther
Routine pulmonary physiotherapy
| Study group | Role | What they receive |
|---|---|---|
| Bottle-PEP | Experimental | Bottle-PEP Receives: Other: Bottle-PEP |
| Routine physiotherapy | Active comparator | v Receives: Other: Routine physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
6 minute walk test
distance of meters walked in 6 minutes
Measured: every 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2021
- Study start1 Apr 2019
- Primary completion31 Oct 2020
- Study completion31 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04961008
- Sponsor's protocol ID
- 09.2019. 424
- Status last verified
- Jul 2021
- First submitted
- 9 Jul 2021
- Last updated
- 14 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Sustainability in Bottle PEP in Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT04961008
- Acronym / sponsor ID
- 09.2019. 424
- Conditions
- Cystic Fibrosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 31 Oct 2020 (actual)
- Study completion
- 31 Oct 2020 (actual)
- First posted
- 14 Jul 2021 (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.
The study aims to investigate the sustainability of Bottle-PEP in patients with cystic fibrosis
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bottle-PEP | Experimental | Other: Bottle-PEPBottle-PEP |
| Routine physiotherapy | Active comparator | Other: Routine physiotherapyv |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Diagnosis of cystic fibrosis
- Acute exacerbation
Key exclusion criteria (1 listed)
- Any contraindication using the Bottle - PEP such as the presence of pneumothorax
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 |
|---|---|---|
| Bottle-PEPA device that gives positive pressure from a bottle with the help of a non deflating tube | Other | Bottle-PEP |
| Routine physiotherapyRoutine pulmonary physiotherapy | Other | Routine physiotherapy |
Primary outcome
6 minute walk test
Time frame: every 3 months
distance of meters walked in 6 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2021.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bottle-PEP and Routine physiotherapy in people with Cystic Fibrosis, run by Marmara University at 1 site in Turkey (Türkiye).
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 2 inclusion and 1 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: finished, as of the sponsor's last update on 14 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
6 minute walk test (time frame: every 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Jul 2021.