Lung DiseasesNCT03185650
Evaluation of Regional Lung Deposition of Inhaled Saline Using the tPAD Device
A study testing tPAD Device and PARI LC Star Nebulizer in people with Lung Diseases, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
Purpose: Characterize the depositional attributes of a specialized trans-nasal aerosol delivery device in healthy people using clinical measurements of mucociliary clearance. Procedures (methods): 14% hypertonic saline (HS) aerosol containing the radio tracer Tc99m-sulfur colloid will be delivered via the tPAD and… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Lung Diseases
- What is being tested?
- tPAD Device and PARI LC Star Nebulizer
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jul 2017to 27 Jul 2018
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects aged 18 to 65 years (inclusive), and with a body mass index (BMI) < 30 kg/m2.
- Non-pregnant female subjects must be either not sexually active, post-menopausal, surgically sterilized, or agree to use an appropriate "double-barrier" method (such as a diaphragm and condom); or, must currently be using a prescribed transdermal, injection, implant, or oral contraceptive during study participation.
- Subjects who are in good health, as determined by a medical history and examination.
- Subjects who have normal lung function with a FEV1 ≥80% predicted and a FEV1/FVC >70%.
- Subjects who are capable of providing written informed consent in English to participate in the study.
Who cannot join
- Subjects who have evidence of an upper or lower respiratory infection or clinically significant illness at entry or within 14 days of the start of dosing.
- Subjects with lung diseases as defined by a FEV1 <80% or a FEV1/FVC <70%
- Subjects on inhaled medications, such as short or long acting bronchodilators or inhaled corticosteroids, will be excluded.
- Subjects with a history of allergy or intolerance to albuterol or hypertonic saline.
- Subjects with active chronic or acute rhinosinusitis or other nasal or sinus abnormality or disease.
- Subjects who have a present history of any clinically significant neurologic, gastrointestinal, renal, hepatic, cardiovascular, psychological, pulmonary, metabolic, endocrine, hematological disorder or disease, substance abuse, or any other major disorder or disease.
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- Subjects who have had radiation exposure within the past year that would cause them to exceed Federal Regulations of 15 Rem annually by participating in this study. The study team will determine this.
- Subjects with a history of smoking within the last 3 months.
- Subjects with a positive pregnancy test or who are pregnant or are nursing.
- Subjects who, in the opinion of the Principal Investigator, should not participate in the study.
- Subjects with a BMI >30 kg/m2
- Subjects who are taller than Height >6'2"
- Subjects who have facial hair that they are not willing to shave
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
About this study
Official title: Evaluation of Regional Lung Deposition of Inhaled Saline Using the Trans-Nasal Pulmonary Aerosol Delivery Device in Healthy, Non-Smoking Adult Subjects
Purpose: Characterize the depositional attributes of a specialized trans-nasal aerosol delivery device in healthy people using clinical measurements of mucociliary clearance.
Procedures (methods): 14% hypertonic saline (HS) aerosol containing the radio tracer Tc99m-sulfur colloid will be delivered via the tPAD and compared to the well characterized PARI LC Star nebulizer (7% HS) using planar gamma scintigraphy (i.e. particle clearance). The fraction of sulfur colloid particles that clear over the ensuing 24 hours with each device will indicate the fraction deposited in conducting airways.
Read the detailed description
Purpose: This is an early device characterization study to define the fraction of delivered aerosol generated by a novel nebulizer (tPAD) that deposits in conducting airways.
Design: Open label, cross-over design, using a standard oral nebulizer (PARI LC Star) as a comparator. The order of visits will be randomized.
Methods: Gamma scintigraphy will be performed following use of each device on separate study visits.
Primary Outcome: Fraction of inhaled particles that clears over 24 hours.
- Conditions
- Lung Diseases
- Being tested
- tPAD Device, PARI LC Star Nebulizer
- Keywords
- Healthy Volunteers
- Medical subject headings
- Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tPAD DeviceDevice
A novel, transnasal aerosol generator
PARI LC Star NebulizerDevice
Standard oral nebulizer
| Study group | Role | What they receive |
|---|---|---|
| tPAD, then PARI LC Star Nebulizer | Other | tPAD device delivering 14% HS labelled with technetium-99m sulfur colloid particles separated by 2-28 days and then PARI LC delivering 7% HS labeled with technetium-99m sulfur colloid particles. Receives: Device: tPAD Device; Device: PARI LC Star Nebulizer |
| PARI LC Star Nebulizer, then tPAD | Other | PARI LC delivering 7% HS labelled with technetium-99m sulfur colloid particles separated by 2-28 days and then tPAD device delivering 14% HS labelled with technetium-99m sulfur colloid particles Receives: Device: tPAD Device; Device: PARI LC Star Nebulizer |
What is being measured
The primary outcome is the main question the study is designed to answer.
24-hour clearance fraction
The percentage of initially deposited aerosol particles that clear over 24 hours will be measured with gamma scintigraphy after 24 hours
Measured: 24 hours
Secondary outcomes (1)
Central:Peripheral Deposition Ratio
The ratio of labelled particles initially deposited in the central and peripheral lung zones will be assessed to characterize aerosol targeting of the lung
Measured: 0-4 minutes after deposition
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2017
- Study start27 Jul 2017
- Primary completion27 Jul 2018
- Study completion27 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung DiseasesStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe 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
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Healthy subjects will use each nebulizer device in random order at separate study visits.
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Parion Sciences
- Responsible party
- Sponsor
- Investigators
- Scott Donaldson, MD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03185650
- Sponsor's protocol ID
- 16-2124
- Status last verified
- Jul 2018
- First submitted
- 9 Jun 2017
- Last updated
- 3 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- 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 3 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Regional Lung Deposition of Inhaled Saline Using the Trans-Nasal Pulmonary Aerosol Delivery Device in Healthy, Non-Smoking Adult Subjects
- ClinicalTrials.gov ID
- NCT03185650
- Acronym / sponsor ID
- 16-2124
- Conditions
- Lung Diseases
- Keywords
- Healthy Volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Parion Sciences
- Study start
- 27 Jul 2017 (actual)
- Primary completion
- 27 Jul 2018 (actual)
- Study completion
- 27 Jul 2018 (actual)
- First posted
- 14 Jun 2017 (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.
Purpose: Characterize the depositional attributes of a specialized trans-nasal aerosol delivery device in healthy people using clinical measurements of mucociliary clearance.
Procedures (methods): 14% hypertonic saline (HS) aerosol containing the radio tracer Tc99m-sulfur colloid will be delivered via the tPAD and compared to the well characterized PARI LC Star nebulizer (7% HS) using planar gamma scintigraphy (i.e. particle clearance). The fraction of sulfur colloid particles that clear over the ensuing 24 hours with each device will indicate the fraction deposited in conducting airways.
Detailed description
Purpose: This is an early device characterization study to define the fraction of delivered aerosol generated by a novel nebulizer (tPAD) that deposits in conducting airways.
Design: Open label, cross-over design, using a standard oral nebulizer (PARI LC Star) as a comparator. The order of visits will be randomized.
Methods: Gamma scintigraphy will be performed following use of each device on separate study visits.
Primary Outcome: Fraction of inhaled particles that clears over 24 hours.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Healthy subjects will use each nebulizer device in random order at separate study visits.
| Arm | Type | Receives |
|---|---|---|
| tPAD, then PARI LC Star Nebulizer | Other | Device: tPAD Device, Device: PARI LC Star NebulizertPAD device delivering 14% HS labelled with technetium-99m sulfur colloid particles separated by 2-28 days and then PARI LC delivering 7% HS labeled with technetium-99m sulfur colloid particles. |
| PARI LC Star Nebulizer, then tPAD | Other | Device: tPAD Device, Device: PARI LC Star NebulizerPARI LC delivering 7% HS labelled with technetium-99m sulfur colloid particles separated by 2-28 days and then tPAD device delivering 14% HS labelled with technetium-99m sulfur colloid particles |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects aged 18 to 65 years (inclusive), and with a body mass index (BMI) < 30 kg/m2.
- Non-pregnant female subjects must be either not sexually active, post-menopausal, surgically sterilized, or agree to use an appropriate "double-barrier" method (such as a diaphragm and condom); or, must currently be using a prescribed transdermal, injection, implant, or oral contraceptive during study participation.
- Subjects who are in good health, as determined by a medical history and examination.
- Subjects who have normal lung function with a FEV1 ≥80% predicted and a FEV1/FVC >70%.
- Subjects who are capable of providing written informed consent in English to participate in the study.
Key exclusion criteria (13 listed)
- Subjects who have evidence of an upper or lower respiratory infection or clinically significant illness at entry or within 14 days of the start of dosing.
- Subjects with lung diseases as defined by a FEV1 <80% or a FEV1/FVC <70%
- Subjects on inhaled medications, such as short or long acting bronchodilators or inhaled corticosteroids, will be excluded.
- Subjects with a history of allergy or intolerance to albuterol or hypertonic saline.
- Subjects with active chronic or acute rhinosinusitis or other nasal or sinus abnormality or disease.
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 |
|---|---|---|
| tPAD DeviceA novel, transnasal aerosol generator | Device | PARI LC Star Nebulizer, then tPAD, tPAD, then PARI LC Star Nebulizer |
| PARI LC Star NebulizerStandard oral nebulizer | Device | PARI LC Star Nebulizer, then tPAD, tPAD, then PARI LC Star Nebulizer |
Primary outcome
24-hour clearance fraction
Time frame: 24 hours
The percentage of initially deposited aerosol particles that clear over 24 hours will be measured with gamma scintigraphy after 24 hours
1 secondary outcome
Central:Peripheral Deposition Ratio
Time frame: 0-4 minutes after deposition
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 3 Oct 2018.
- 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.
Scott Donaldson, MD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tPAD Device and PARI LC Star Nebulizer in people with Lung Diseases, run by University of North Carolina, Chapel Hill 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 13 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 3 Oct 2018. 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?
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?
24-hour clearance fraction (time frame: 24 hours). 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 3 Oct 2018.