Cystic FibrosisNCT04743206
Airway Clearance for Pediatric and Adult Cystic Fibrosis Patients Using a Portable Intra-Pulmonary Percussion Device
A study testing Standard Airway Clearance device and Portable Internal Airway Percussion device in people with Cystic Fibrosis, run by University of Florida at 1 site in United States.
Trial summary
This is a pilot study where the investigators aim to compare initial use of the standard airway clearance device (SACD), most commonly used being High frequency vest airway clearance system (VEST) with subsequent use of a Portable Intra-Pulmonary Percussion Device (PIAPD) in patients with cystic fibrosis (CF) ages 6… Read more about this study
- Who is it for?
- Ages 6 to 21 years
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Standard Airway Clearance device and Portable Internal Airway Percussion device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 18 May 2021to 1 Aug 2021
- 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 6 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Ages 6-21 years
- Cystic fibrosis stable by physician assessment
- Assents to forego additional experimental treatments during the study
- Currently using and familiar with airway clearance therapy for treatment of cystic fibrosis
- Participant (or parent or legal guardian if the participant is a minor) is willing to provide -----Informed Consent
Who cannot join
- FEV1 < 40% predictive
- Pneumothorax
- Hemoptysis
- Coronavirus disease (COVID) 19 diagnosis within last 14 days
- Any condition that, in the opinion of the investigator, would interfere with the study conduct or the safety of the participant
- Additional Exclusion Criteria: Outpatient Arm (in addition to general exclusion criteria above) Decrease in FEV1 > 10% from baseline over last 12 months Antibiotic Initiation for acute CF exacerbation Hospitalization for CF Exacerbation
- Additional Exclusion Criteria: Inpatient Arm (in addition to general exclusion criteria above) Failure to increase FEV1 > 10 % from initial Pulmonary function testing (PFTs) on admission by day 9 of hospitalization.
Trial locations and contacts
1 site in 1 country.
United States1 site
UF Medical Plaza Pulmonary Clinic
Gainesville, Florida, 32610
About this study
Official title: Airway Clearance for Pediatric and Adult Cystic Fibrosis Patients Using a Portable Intra-Pulmonary Percussion Device (PIAPD)
This is a pilot study where the investigators aim to compare initial use of the standard airway clearance device (SACD), most commonly used being High frequency vest airway clearance system (VEST) with subsequent use of a Portable Intra-Pulmonary Percussion Device (PIAPD) in patients with cystic fibrosis (CF) ages 6 -21 years. The primary hypothesis is that there is no effect of PIAPD on Forced expiratory volume in 1 second (FEV1) 2 hours after use, there is no effect on perception of effort and efficacy for the PIAPD. If both are equally effective, the latter device provides an alternative that is both cheaper and portable.
- Conditions
- Cystic Fibrosis
- Being tested
- Standard Airway Clearance device, Portable Internal Airway Percussion device
- Keywords
- Airway Clearance
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Airway Clearance deviceDevice
Subjects will be using their home standard airway clearance device, VEST (High Frequency Chest Wall Oscillation VEST) for 2 weeks followed by PIAPD.
Portable Internal Airway Percussion deviceDevice
Subjects will be using the investigational device, PIAPD (Portable Internal Airway Percussion Device) for 2 weeks.
| Study group | Role | What they receive |
|---|---|---|
| PIAPD-Portable Internal Airway Percussion device | Experimental | There will be an outpatient arm using the PIAPD-Portable Internal Airway Percussion Device. Receives: Device: Portable Internal Airway Percussion device |
| SACD-Standard Airway Clearance device | Active comparator | There will be an Outpatient Arm using the SACD, VEST (High Frequency Chest Wall Oscillation VEST) Standard Airway Clearance Device. Receives: Device: Standard Airway Clearance device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygen Saturation % by Pulse Oximetry
oxygen saturation will be obtained by home pulse oximeter device.
Measured: O2 saturation measured immediately prior to treatment and 2 hours after treatment - one-time pre/post treatment in week 1; and one-time pre/post treatment in week 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2021
- Study start18 May 2021
- Primary completion31 Jul 2021
- Study completion1 Aug 2021
Why it stopped: recruitment difficulty due to COVID recruitment difficulty due to covid
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 University of FloridaThe 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- This is a pilot study where the investigators aim to compare initial use of the standard airway clearance device (SACD) with subsequent use of a PIAPD in patients with stable cystic fibrosis ages 6 -21 years. The primary hypothesis (Stated as Null) being that there is no effect of PIAPD on FEV1 2 hours after use, there is no effect on perception of effort and efficacy for the PIAPD.
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Silvia Delgado Villalta, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04743206
- Sponsor's protocol ID
- IRB201902662
- Other IDs
- OCR39724
- Status last verified
- Oct 2024
- First submitted
- 3 Feb 2021
- Last updated
- 19 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Airway Clearance for Pediatric and Adult Cystic Fibrosis Patients Using a Portable Intra-Pulmonary Percussion Device (PIAPD)
- ClinicalTrials.gov ID
- NCT04743206
- Acronym / sponsor ID
- IRB201902662
- Conditions
- Cystic Fibrosis
- Keywords
- Airway Clearance
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: recruitment difficulty due to COVID recruitment difficulty due to covid
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 18 May 2021 (actual)
- Primary completion
- 31 Jul 2021 (actual)
- Study completion
- 1 Aug 2021 (actual)
- First posted
- 8 Feb 2021 (actual)
- Results
- Posted 19 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a pilot study where the investigators aim to compare initial use of the standard airway clearance device (SACD), most commonly used being High frequency vest airway clearance system (VEST) with subsequent use of a Portable Intra-Pulmonary Percussion Device (PIAPD) in patients with cystic fibrosis (CF) ages 6 -21 years. The primary hypothesis is that there is no effect of PIAPD on Forced expiratory volume in 1 second (FEV1) 2 hours after use, there is no effect on perception of effort and efficacy for the PIAPD. If both are equally effective, the latter device provides an alternative that is both cheaper and portable.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a pilot study where the investigators aim to compare initial use of the standard airway clearance device (SACD) with subsequent use of a PIAPD in patients with stable cystic fibrosis ages 6 -21 years. The primary hypothesis (Stated as Null) being that there is no effect of PIAPD on FEV1 2 hours after use, there is no effect on perception of effort and efficacy for the PIAPD.
| Arm | Type | Receives |
|---|---|---|
| PIAPD-Portable Internal Airway Percussion device | Experimental | Device: Portable Internal Airway Percussion deviceThere will be an outpatient arm using the PIAPD-Portable Internal Airway Percussion Device. |
| SACD-Standard Airway Clearance device | Active comparator | Device: Standard Airway Clearance deviceThere will be an Outpatient Arm using the SACD, VEST (High Frequency Chest Wall Oscillation VEST) Standard Airway Clearance Device. |
Who may qualify
- Ages
- 6 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Ages 6-21 years
- Cystic fibrosis stable by physician assessment
- Assents to forego additional experimental treatments during the study
- Currently using and familiar with airway clearance therapy for treatment of cystic fibrosis
- Participant (or parent or legal guardian if the participant is a minor) is willing to provide -----Informed Consent
Key exclusion criteria (7 listed)
- FEV1 < 40% predictive
- Pneumothorax
- Hemoptysis
- Coronavirus disease (COVID) 19 diagnosis within last 14 days
- Any condition that, in the opinion of the investigator, would interfere with the study conduct or the safety of the participant
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 |
|---|---|---|
| Standard Airway Clearance deviceSubjects will be using their home standard airway clearance device, VEST (High Frequency Chest Wall Oscillation VEST) for 2 weeks followed by PIAPD. | Device | SACD-Standard Airway Clearance device |
| Portable Internal Airway Percussion deviceSubjects will be using the investigational device, PIAPD (Portable Internal Airway Percussion Device) for 2 weeks. | Device | PIAPD-Portable Internal Airway Percussion device |
Primary outcome
Oxygen Saturation % by Pulse Oximetry
Time frame: O2 saturation measured immediately prior to treatment and 2 hours after treatment - one-time pre/post treatment in week 1; and one-time pre/post treatment in week 2
oxygen saturation will be obtained by home pulse oximeter device.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Silvia Delgado Villalta, MD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Airway Clearance device and Portable Internal Airway Percussion device in people with Cystic Fibrosis, run by University of Florida at 1 site in United States.
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 7 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: stopped early, as of the sponsor's last update on 19 Nov 2024. 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 United States. 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 19 Nov 2024). 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?
Oxygen Saturation % by Pulse Oximetry (time frame: O2 saturation measured immediately prior to treatment and 2 hours after treatment - one-time pre/post treatment in week 1; and one-time pre/post treatment in week 2). 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 19 Nov 2024.