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Airway Clearance for Pediatric and Adult Cystic Fibrosis Patients Using a Portable Intra-Pulmonary Percussion Device

Study Purpose

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 Portable Intra-Pulmonary Percussion Device (PIAPD) in patients with cystic fibrosis ages 6 -21 years. The primary hypothesis is 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. If both are equally effective, the latter device provides an alternative that is both cheaper and portable.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	6 Years - 21 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- 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 -----InformedConsent.

Exclusion Criteria:

- FEV1 < 40% predictive.

- Pneumothorax.

- Hemoptysis.

- 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 PFTs on admission by day 9 of hospitalization.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04743206
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	University of Florida
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Silvia Delgado Villalta, MD
Principal Investigator Affiliation	University of Florida
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Cystic Fibrosis

Arms & Interventions

Arms

Experimental: PIAPD-Portable Internal Airway Percussion device

There will be an Inpatient Arm and Outpatient Arm using the Smart One® portable home spirometer

Active Comparator: SACD-Standard Airway Clearance device

There will be an Inpatient Arm and Outpatient Arm using the SACD. A large majority of patients will be using VEST therapy as their standard of care airway clearance. A few might be using an Intrapulmonary Percussion Device that uses a mechanism different from the device the study will be testing.

Interventions

Device: - Standard Airway Clearance device

A large majority of our patients will be using VEST therapy as their standard of care airway clearance

Device: - Portable Internal Airway Percussion device

Smart One® portable home spirometer

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

UF Medical Plaza Pulmonary Clinic, Gainesville, Florida

Status

Recruiting

Address

UF Medical Plaza Pulmonary Clinic

Gainesville, Florida, 32610

Site Contact

Jennifer Hosford

Jennifer.Hosford@peds.ufl.edu

352-301-0676