Healthy SubjectsNCT01617369
Study to Characterize the Durability of Hypertonic Saline to Enhance Mucociliary Clearance in Healthy Subjects
A study testing Hypertonic Saline in people with Healthy Subjects, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
The purpose of this research study is to learn about how long hypertonic saline (HS) works in healthy subjects. Inhaled hypertonic saline is one of the medications used to treat Cystic Fibrosis (CF). In CF and more common lung diseases like chronic bronchitis, mucus builds up in the lungs. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- Hypertonic Saline
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2012to Mar 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy subjects, without respiratory or cardiac comorbidities
- Age 18-55 years, inclusive
- FEV1 > 80% predicted and FEV1/FVC ratio >70%
- 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 capable of providing their written informed consent to participate in the study
Who cannot join
- History of smoking > 10 pack-years
- Any history of smoking within 60 days of screening
- Acute upper or lower respiratory illness within 30 days of screening
- Respiratory medication for any indication within 30 days of screening
- History of asthma, chronic bronchitis, or other chronic lung disease
- History of intolerance to hypertonic saline
Show all 10Show fewer
- Women who are pregnant, lactating, or of childbearing potential who are unwilling to use an acceptable method of contraception throughout the duration of the study.
- Any condition that, in the opinion of the investigator, would potentially jeopardize the safety of the participant or the integrity of the study
- History of radiation exposure within the past year that would cause the subject to exceed limits for adults established by Federal Regulations
- Subjects who, in the opinion of the Principal Investigator, should not participate in the study
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: A Study to Characterize the Durability of Hypertonic Saline for the Enhancement of Mucociliary Clearance in Healthy Subjects
The purpose of this research study is to learn about how long hypertonic saline (HS) works in healthy subjects. Inhaled hypertonic saline is one of the medications used to treat Cystic Fibrosis (CF). In CF and more common lung diseases like chronic bronchitis, mucus builds up in the lungs. Hypertonic saline and other medications currently being developed may help patients with these lung diseases by speeding up mucus clearance from the lung. For these treatments to be effective, they likely need to be able to act for at lease several hours. Investigators are able to measure how lung treatments like hypertonic saline work by conducting a Mucociliary Clearance (MCC) scan. Currently, the investigators do not know how long hypertonic saline works in people who do not have CF. Investigators plan to use this information to improve the design and testing of new treatments for patients with chronic bronchitis.
Objectives:
- The investigators will use MCC measurements to determine the durability of action of hypertonic saline in healthy (i.e. non-CF) subjects.
- The investigators will determine the intra- and inter-individual variability of baseline MCC measurements using a slow inhalation/large particle protocol in healthy subjects to guide future sample size calculations.
- Conditions
- Healthy Subjects
- Being tested
- Hypertonic Saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypertonic SalineDevice
2.8% NaCl x 4ml via nebulizer
| Study group | Role | What they receive |
|---|---|---|
| Acute Hypertonic Saline Effect | Experimental | 2.8% NaCl inhaled 30 minutes before Mucociliary Clearance measured. Receives: Device: Hypertonic Saline |
| Sustained Hypertonic Saline Effect | Active comparator | 2.8% NaCl inhaled 4 hours before Mucociliary Clearance measured. Receives: Device: Hypertonic Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Whole Lung Mucociliary Clearance
The primary outcome of mucociliary clearance (MCC) will be depicted by calculating the average rate of isotope clearance (%) from the whole lung compartment, measured for 90 minutes after isotope inhalation (MCC-Ave 90), using data points collected every 10 minutes.
Absolute change in MCC-Ave90 from baseline reported for each arm
Measured: 30 minutes and 4 hours after inhalation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2012 (estimated)
- Study startJun 2012
- Primary completionMar 2013
- Study completionMar 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 Healthy SubjectsStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Subjects completed mucociliary clearance measurements (via gamma scintigraphy) at baseline, 30 minutes after inhaling 2.8% NaCl, and 4 hours after inhaling 2.8% NaCl at separate study visits to characterize acute vs. sustained effects of inhaled 2.8% NaCl on this physiologic process.
- 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
- Gilead Sciences
- Responsible party
- Principal investigator, Scott Donaldson, MD, University of North Carolina, Chapel Hill
- Investigators
- Scott Donaldson, MD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01617369
- Sponsor's protocol ID
- 11-1932
- Status last verified
- Dec 2014
- First submitted
- 6 Jun 2012
- Last updated
- 4 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- 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 4 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Characterize the Durability of Hypertonic Saline for the Enhancement of Mucociliary Clearance in Healthy Subjects
- ClinicalTrials.gov ID
- NCT01617369
- Acronym / sponsor ID
- 11-1932
- Conditions
- Healthy Subjects
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Gilead Sciences
- Study start
- Jun 2012
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 12 Jun 2012 (estimated)
- Results
- Posted 4 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research study is to learn about how long hypertonic saline (HS) works in healthy subjects. Inhaled hypertonic saline is one of the medications used to treat Cystic Fibrosis (CF). In CF and more common lung diseases like chronic bronchitis, mucus builds up in the lungs. Hypertonic saline and other medications currently being developed may help patients with these lung diseases by speeding up mucus clearance from the lung. For these treatments to be effective, they likely need to be able to act for at lease several hours. Investigators are able to measure how lung treatments like hypertonic saline work by conducting a Mucociliary Clearance (MCC) scan. Currently, the investigators do not know how long hypertonic saline works in people who do not have CF. Investigators plan to use this information to improve the design and testing of new treatments for patients with chronic bronchitis.
Objectives:
- The investigators will use MCC measurements to determine the durability of action of hypertonic saline in healthy (i.e. non-CF) subjects.
- The investigators will determine the intra- and inter-individual variability of baseline MCC measurements using a slow inhalation/large particle protocol in healthy subjects to guide future sample size calculations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Subjects completed mucociliary clearance measurements (via gamma scintigraphy) at baseline, 30 minutes after inhaling 2.8% NaCl, and 4 hours after inhaling 2.8% NaCl at separate study visits to characterize acute vs. sustained effects of inhaled 2.8% NaCl on this physiologic process.
| Arm | Type | Receives |
|---|---|---|
| Acute Hypertonic Saline Effect | Experimental | Device: Hypertonic Saline2.8% NaCl inhaled 30 minutes before Mucociliary Clearance measured. |
| Sustained Hypertonic Saline Effect | Active comparator | Device: Hypertonic Saline2.8% NaCl inhaled 4 hours before Mucociliary Clearance measured. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy subjects, without respiratory or cardiac comorbidities
- Age 18-55 years, inclusive
- FEV1 > 80% predicted and FEV1/FVC ratio >70%
- 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 capable of providing their written informed consent to participate in the study
Key exclusion criteria (10 listed)
- History of smoking > 10 pack-years
- Any history of smoking within 60 days of screening
- Acute upper or lower respiratory illness within 30 days of screening
- Respiratory medication for any indication within 30 days of screening
- History of asthma, chronic bronchitis, or other chronic lung 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 |
|---|---|---|
| Hypertonic Saline2.8% NaCl x 4ml via nebulizer | Device | Acute Hypertonic Saline Effect, Sustained Hypertonic Saline Effect |
Primary outcome
Change in Whole Lung Mucociliary Clearance
Time frame: 30 minutes and 4 hours after inhalation
The primary outcome of mucociliary clearance (MCC) will be depicted by calculating the average rate of isotope clearance (%) from the whole lung compartment, measured for 90 minutes after isotope inhalation (MCC-Ave 90), using data points collected every 10 minutes. Absolute change in MCC-Ave90 from baseline reported for each arm
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2017.
- 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.
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 Hypertonic Saline in people with Healthy Subjects, 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 10 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 4 May 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?
Yes. Results are posted in the registry (first posted 4 Apr 2017). 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?
Change in Whole Lung Mucociliary Clearance (time frame: 30 minutes and 4 hours after inhalation). 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 4 May 2017.