COPDtPADNCT02341183

Novel Therapies for Muco-Obstructive Lung Diseases: Testing the Transnasal Pulmonary Delivery Device in COPD/CB Subjects

A study testing tPAD and 7% hypertonic saline (510K approved as a device) in people with COPD and Chronic Bronchitis, run by University of North Carolina, Chapel Hill at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record

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Trial summary

The primary objective of this study is to assess tolerability and effect of HS (hypertonic saline) delivered with the tPAD (transnasal Pulmonary Aerosol Delivery) device on mucociliary clearance (MCC) in chronic obstructive pulmonary disease/chronic bronchitis (COPD/CB) subjects. Read more about this study

Who is it for?: Ages 40 to 80 years
Conditions the study is for: COPD, Chronic Bronchitis
What is being tested?: tPAD and 7% hypertonic saline (510K approved as a device)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 0 participants
Where: 1 siteUnited States
Study dates: May 2016to May 2016
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 40 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subjects who meet the following criteria will be eligible for study participation:
Subjects aged 40 to 80 years (inclusive), and with a body mass index (BMI) < 35 kg/m2
Female subjects must be non-pregnant and 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 their baseline state of health, as determined by a medical history and examination
Subjects who have normal lung function with a FEV1 of 30% - 80% predicted and a FEV1/FVC <70%
Subjects who are capable of providing written informed consent in English to participate in the study
Produces sputum two days per week or more, on average.
History of smoking cigarettes ≥ 10 pack years.

Who cannot join

Subjects will be excluded from the study according to the following criteria:
Subjects who use oxygen continuously or require it at night.
Subjects with an FEV1 < 30% or > 80% or an FEV1/FVC of ≥70% at screening.
Subjects who chronically require > 10mg per day of prednisone (or equivalent corticosteroid dose).
Subjects with a concomitant presence of congestive heart failure, active coronary syndromes, or other disease that in the opinion of the investigator would increase the risk resulting from participation.
Subjects with a recent change in respiratory medications, including new antibiotic or systemic corticosteroid interventions within the last 4 weeks.

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Subjects with a history of intolerance or hypersensitivity to hypertonic saline or short acting inhaled beta agonists.
Subjects with significant bronchoreactivity by examination or PFT testing that, in the opinion of the investigator, would increase the risk of HS use.
Subjects who have had radiation exposure within the 12 months prior to study participation that would cause them to exceed Federal Regulations by participating in this study.
Subjects with symptomatically active, chronic or acute rhinosinusitis, or other nasal abnormality that could interfere with aerosol delivery or impact subject safety.
Subjects with a positive pregnancy test or who are nursing.
Subjects who have been diagnosed with obstructive sleep apnea.
Subjects who, in the opinion of the Principal Investigator, should not participate in the study.
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Trial locations and contacts

1 site in 1 country.

United States1 site

University of North Carolina Chapel Hill
Chapel Hill, North Carolina, 27599

Other trials in United States

About this study

Official title: Novel Therapies for Muco-Obstructive Lung Diseases: A Study of Tolerability and MCC Effect of Hypertonic Saline Delivered Via the tPAD in Patients With Chronic Bronchitis

Read the detailed description

The beneficial effects of inhaled HS in CF patients (cystic fibrosis) have been well established. Concerns over safety and intolerability in patients with COPD/CB, based in part upon experiences with ultrasonic delivery devices, have limited interest in further exploring this therapeutic option. Although our clinical data suggests that HS delivered via jet nebulizer is generally well tolerated in patients with COPD/CB, our pre-clinical data suggests that cell shrinkage, the release of proinflammatory cytokines (i.e. IL-8), and transient cilia stasis is dependent upon the rate of aerosol delivery.

Slow/continuous delivery may avoid most/all of these detrimental effects while promoting an even greater cumulative ASL (airway surface liquid) volume increase. To translate these data into a feasible treatment strategy, a comfortable, quiet delivery device that can be used for long time periods (i.e. overnight) was developed to slowly deliver HS via a nasal cannula device while avoiding aerosol rain-out in the device's tubing. Use of a computational model (MPPD: Multiple-Path Particle Dosimetry V2.0) predicts that this device, which generates a 2 um MMAD aerosol particle, will achieve -5-8% lung deposition. When tuned to an output of ~0.033 ml/min, 8 hours of use is predicted to deposit a minimum of 140 mg of NaCI onto airway surfaces. This compares favorably to the estimated mass delivered via jet nebulizer in the clinically successful study of HS in CF (110 mg/day, assuming 19.75% deposition fraction with the Pari LC PLUS).

The proposed study is a single site, randomized, open label, cross-over trial designed to measure the tolerability and effect on mucociliary clearance following 7% HS delivered via tPAD for eight hours overnight to COPD/CB subjects. Comparison will be to measurements made following no treatment during an overnight stay. COPD/CB subjects meeting inclusion and exclusion criteria will be enrolled in the study. All study procedures will be conducted in the Clinical Translational Research Center (CTRC) at UNC Hospitals and the EPA building on Mason Farm Rd on the UNC Hospitals campus.

Conditions: COPD, Chronic Bronchitis
Being tested: tPAD, 7% hypertonic saline (510K approved as a device)
Medical subject headings: Pulmonary Disease, Chronic Obstructive, Bronchitis, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

tPADDevice
7% NaCl administered continuously for 8 hours, overnight, via the tPAD device
7% hypertonic saline (510K approved as a device)Device
Subjects will receive overnight treatments of 7% HS via the tPAD device in both comparators, but in a randomly assigned order as described.

Study groups in NCT02341183
Study group	Role	What they receive
A: Treatment order: tPAD treatment, then no treatment	Active comparator	Subjects will receive one overnight treatment with 7% hypertonic saline administered via the tPAD device. They will then have one overnight stay without treatment. Receives: Device: tPAD; Device: 7% hypertonic saline (510K approved as a device)
B: Treatment order: no treatment, then tPAD treatment	Active comparator	Subjects will have overnight stay w/o treatment, and one overnight treatment with 7% hypertonic saline administered via the tPAD device. Receives: Device: tPAD; Device: 7% hypertonic saline (510K approved as a device)

What is being measured

The primary outcome is the main question the study is designed to answer.

Mucociliary Clearance Rate (MCC60)
The primary study outcome, MCC60, will serve as the primary descriptor of the mucociliary clearance rate. This assay will be begun as quickly as possible after competing the tPAD treatment (<60 minutes in all cases). MCC60 is derived by calculating the average rate of particle clearance observed during the first 60 minutes of the MCC scan procedure (MCC60; units = % cleared/time), using clearance values determined every 10 minutes for 60 minutes following inhalation of radiolabeled particles. Results obtained immediately after tPAD treatment will be compared to baseline values. Similarly, average clearance through other time domains (30 min, 90 min, 24 hrs), and from specific regions of interest (central lung; peripheral lung) will be reported as secondary MCC outcomes.
Measured: The MCC outcome measure will be performed as quickly as possible (within 60 minutes) after overnight tPAD treatment

Secondary outcomes (2)

Symptom survey
A customized survey of nasal, sleep, and respiratory symptoms will be administered to qualitatively assess the experience with the tPAD device.
Measured: The outcome measure will be assessed after visits 1 and 3, immediately following each overnight visit (tPAD vs. no treatment)
Spirometry
For treatment visits, spirometry will be obtained before treatment and after the overnight treatment following the MCC study to assess safety of the assigned interventions.
Measured: Spirometry will be performed before each treatment visit (tPAD vs. no treatment) on Visit 1 and 3, and again after completing the assigned treatment, approximately 12 hours later

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2016May 2016

First posted19 Jan 2015 (estimated)
Study startMay 2016
Primary completionMay 2016
Study completionMay 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for COPDStudies 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: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02341183
Sponsor's protocol ID: Pro00057004
Acronym: tPAD
Status last verified: May 2016
First submitted: 2 Dec 2014
Last updated: 23 Jun 2017
Results posted: No
Data monitoring committee: No
FDA-regulated device: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 23 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Novel Therapies for Muco-Obstructive Lung Diseases: A Study of Tolerability and MCC Effect of Hypertonic Saline Delivered Via the tPAD in Patients With Chronic Bronchitis
ClinicalTrials.gov ID: NCT02341183
Acronym / sponsor ID: tPAD / Pro00057004
Conditions: COPD, Chronic Bronchitis
Study type: Interventional
Recruitment status: Withdrawn
Enrolment: 0 participants (actual)
Lead sponsor: University of North Carolina, Chapel HillUniversity, hospital or other
Study start: May 2016
Primary completion: May 2016 (actual)
Study completion: May 2016 (actual)
First posted: 19 Jan 2015 (estimated)
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.

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
A: Treatment order: tPAD treatment, then no treatment	Active comparator	Device: tPAD, Device: 7% hypertonic saline (510K approved as a device)Subjects will receive one overnight treatment with 7% hypertonic saline administered via the tPAD device. They will then have one overnight stay without treatment.
B: Treatment order: no treatment, then tPAD treatment	Active comparator	Device: tPAD, Device: 7% hypertonic saline (510K approved as a device)Subjects will have overnight stay w/o treatment, and one overnight treatment with 7% hypertonic saline administered via the tPAD device.

Who may qualify

Ages: 40 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Subjects aged 40 to 80 years (inclusive), and with a body mass index (BMI) < 35 kg/m2
Female subjects must be non-pregnant and 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 their baseline state of health, as determined by a medical history and examination
Subjects who have normal lung function with a FEV1 of 30% - 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 (14 listed)

Subjects who use oxygen continuously or require it at night.
Subjects with an FEV1 < 30% or > 80% or an FEV1/FVC of ≥70% at screening.
Subjects who chronically require > 10mg per day of prednisone (or equivalent corticosteroid dose).
Subjects with a concomitant presence of congestive heart failure, active coronary syndromes, or other disease that in the opinion of the investigator would increase the risk resulting from participation.
Subjects with a recent change in respiratory medications, including new antibiotic or systemic corticosteroid interventions within the last 4 weeks.

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
tPAD7% NaCl administered continuously for 8 hours, overnight, via the tPAD device	Device	A: Treatment order: tPAD treatment, then no treatment, B: Treatment order: no treatment, then tPAD treatment
7% hypertonic saline (510K approved as a device)Subjects will receive overnight treatments of 7% HS via the tPAD device in both comparators, but in a randomly assigned order as described.	Device	A: Treatment order: tPAD treatment, then no treatment, B: Treatment order: no treatment, then tPAD treatment

Primary outcome

Mucociliary Clearance Rate (MCC60)
Time frame: The MCC outcome measure will be performed as quickly as possible (within 60 minutes) after overnight tPAD treatment
The primary study outcome, MCC60, will serve as the primary descriptor of the mucociliary clearance rate. This assay will be begun as quickly as possible after competing the tPAD treatment (<60 minutes in all cases). MCC60 is derived by calculating the average rate of particle clearance observed during the first 60 minutes of the MCC scan procedure (MCC60; units = % cleared/time), using clearance values determined every 10 minutes for 60 minutes following inhalation of radiolabeled particles. Results obtained immediately after tPAD treatment will be compared to baseline values. Similarly, average clearance through other time domains (30 min, 90 min, 24 hrs), and from specific regions of interest (central lung; peripheral lung) will be reported as secondary MCC outcomes.

2 secondary outcomes

Symptom survey
Time frame: The outcome measure will be assessed after visits 1 and 3, immediately following each overnight visit (tPAD vs. no treatment)
Spirometry
Time frame: Spirometry will be performed before each treatment visit (tPAD vs. no treatment) on Visit 1 and 3, and again after completing the assigned treatment, approximately 12 hours later

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2017.

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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 H. Donaldson, MD principal investigator

Associate Professor, Department of Medicine, Division of Pulmonary/Critical Care Medicine, UNC 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 and 7% hypertonic saline (510K approved as a device) in people with COPD and Chronic Bronchitis, 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 8 inclusion and 14 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: withdrawn, as of the sponsor's last update on 23 Jun 2017. 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 was withdrawn before enrolling participants, so there are no results.

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?

Mucociliary Clearance Rate (MCC60) (time frame: The MCC outcome measure will be performed as quickly as possible (within 60 minutes) after overnight tPAD treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02341183.

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 23 Jun 2017.