Cystic FibrosisNCT02083263
Non Invasive Ventilation as Airway Clearance in Patients With Cystic Fibrosis
A study testing Bilevel and PEP mask in people with Cystic Fibrosis, run by Karolinska University Hospital at 1 site in Sweden.
Trial summary
With the use of Non invasive ventilation the patients with cystic fibrosis will have better lung function (FEV1). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Bilevel and PEP mask
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteSweden
- Study dates
- Oct 2012to Sep 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with CF older than 18 years
- FEV1 between 20% and 69% of predictive.
- No acute exacerbation.
- No Burkhordelia Cepacia/MRSA colonization.
Who cannot join
- Children under 18 year
- acute exacerbation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of Non Invasive Ventilation With High Pressure as Airways Clearance Technique in Adults Patients With Cystic Fibrosis
With the use of Non invasive ventilation the patients with cystic fibrosis will have better lung function (FEV1).
Read the detailed description
3 months intervention between PEP an Bilevel. The patients will follow up under 3 months.
- Conditions
- Cystic Fibrosis
- Being tested
- Bilevel, PEP mask
- Keywords
- Lung function
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BilevelDevice
3 months
PEP maskDevice
3 months
| Study group | Role | What they receive |
|---|---|---|
| Bilevel | Experimental | Bilevel, 3 months. The treatment was performed twice a day, 1 hour each treatment. Receives: Device: Bilevel |
| PEP mask | Active comparator | PEP mask, 3 months. The treatment was performed twice a day, 1 hour each treatment. Receives: Device: PEP mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lung Function: Lung Clearance Index
Lung clearance index was calculated as the number of lung volume turnovers (cumulative expired volume divided by the functional residual capacity) required to reduce end-tidal nitrogen concentration to 1/40th of the starting value.
Measured: up to 3 months
Secondary outcomes (1)
Blood Gases:1 Month After Chest Physiotherapy Will Take Blood Gases (Kpa).
After physiotherapy will take blood gases (kpa) before chest physiotherapy and perform once a month.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2014 (estimated)
- Study startOct 2012
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by Karolinska University HospitalThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska Institutet
- Responsible party
- Principal investigator, Cecilia Rodriguez, Karolinska University Hospital
- Investigators
- Cecilia Rodriguez, Physio, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02083263
- Sponsor's protocol ID
- CF2012-1
- Status last verified
- Jul 2014
- First submitted
- 16 Nov 2012
- Last updated
- 16 Jul 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Non Invasive Ventilation With High Pressure as Airways Clearance Technique in Adults Patients With Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT02083263
- Acronym / sponsor ID
- CF2012-1
- Conditions
- Cystic Fibrosis
- Keywords
- Lung function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Collaborators
- Karolinska Institutet
- Study start
- Oct 2012
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 11 Mar 2014 (estimated)
- Results
- Posted 3 Jul 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
With the use of Non invasive ventilation the patients with cystic fibrosis will have better lung function (FEV1).
Detailed description
3 months intervention between PEP an Bilevel. The patients will follow up under 3 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bilevel | Experimental | Device: BilevelBilevel, 3 months. The treatment was performed twice a day, 1 hour each treatment. |
| PEP mask | Active comparator | Device: PEP maskPEP mask, 3 months. The treatment was performed twice a day, 1 hour each treatment. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with CF older than 18 years
- FEV1 between 20% and 69% of predictive.
- No acute exacerbation.
- No Burkhordelia Cepacia/MRSA colonization.
Key exclusion criteria (2 listed)
- Children under 18 year
- acute exacerbation.
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 |
|---|---|---|
| Bilevel3 months | Device | Bilevel |
| PEP mask3 months | Device | PEP mask |
Primary outcome
Lung Function: Lung Clearance Index
Time frame: up to 3 months
Lung clearance index was calculated as the number of lung volume turnovers (cumulative expired volume divided by the functional residual capacity) required to reduce end-tidal nitrogen concentration to 1/40th of the starting value.
1 secondary outcome
Blood Gases:1 Month After Chest Physiotherapy Will Take Blood Gases (Kpa).
Time frame: 1 month
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Cecilia Rodriguez, Physio principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bilevel and PEP mask in people with Cystic Fibrosis, run by Karolinska University Hospital at 1 site in Sweden.
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 4 inclusion and 2 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 16 Jul 2014. 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 Sweden. 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?
Yes. Results are posted in the registry (first posted 3 Jul 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Lung Function: Lung Clearance Index (time frame: up to 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 16 Jul 2014.