Moderate to Severe AsthmaNCT03556683
Phase I Assessment of Hypertonic Saline in Moderate to Severe Asthmatics
A study testing 3% Hypertonic Saline, 7% Hypertonic Saline and Salbutamol in people with Moderate to Severe Asthma, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
Purpose: To determine if inhaled hypertonic saline (HS) accelerates airway mucociliary clearance (MCC) in well-controlled moderate to severe asthmatics. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Moderate to Severe Asthma
- What is being tested?
- 3% Hypertonic Saline, 7% Hypertonic Saline and Salbutamol
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2018to 6 Jun 2024
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18-60 of both genders-
- Moderate to severe asthma at baseline (determined by Step 3 therapy or greater or by asthma impairment) and well-controlled asthma at the time of enrollment, as determined by NHLBI Expert Panel Report 3 guidelines for diagnosis and treatment of asthma.
- Negative pregnancy test for females who are not s/p hysterectomy with oophorectomy.
- Forced expiratory volume in 1 sec (FEV1) of at least 70% of predicted for age, sex, height, and race/ethnicity (without use of bronchodilating medications for 12 hours or long acting beta agonists for 24 hours).
- Documented COVID-19 vaccination
Who cannot join
- Subjects who meet any of these criteria are not eligible for enrollment as study participants:
- Clinical Contraindications:
- Any chronic medical condition considered by the PI as a contraindication to the study including significant cardiovascular disease, diabetes, chronic renal disease, chronic thyroid disease, history of chronic infections/immunodeficiency, or history of tuberculosis Any acute infection requiring antibiotics within 4 weeks of study. Mental illness or history of drug or alcohol abuse that, in the opinion of the investigator, would interfere with the participant's ability to comply with study requirements.
- Medications which may impact the results of the study treatment, or may interfere with any other medications potentially used in the study (to include steroids, beta antagonists, non-steroidal anti-inflammatory agents) Active smoking to include e-cigarettes within 1 year of the study, or lifetime of > 10 pack-years of smoking Allergy/sensitivity to study drugs, or their formulations. History of intubation for asthma Unwillingness to use reliable contraception if sexually active (birth control pills/patch, condoms).
- Viral upper respiratory tract infection within 4 weeks of challenge. Radiation exposure history in the past year that would cause the participant to exceed Federal radiation safety guidelines.
- Pregnant women and children (< 18 years as this is age of majority in NC) will also be excluded since the risks associated with hypertonic saline inhalation to the fetus or child and the risk of radiation are unknown and cannot be justified.
Show all 23Show fewer
- Use of the following medications:
- Systemic corticosteroids; subjects with systemic corticosteroid-dependent asthma will be excluded. All use of systemic steroids in the last year will be reviewed by a study physician.
- Use of daily theophylline within the past month
- Use of any immunosuppressant/immunomodulatory therapy within the preceding 12 months
- Use of beta blocking medications
- Receipt of Live Attenuated Influenza Vaccine (LAIV), also known as FluMist®, within the prior 30 days, or any vaccine within the prior 5 days
- Multivitamins, Vitamin C or E or herbal medications in the 4 days prior to the treatment visit
- Non-steroidal anti-inflammatory drugs in the 4 days prior to the treatment visit
- Subjects must be able to withhold morning doses of maintenance inhalers on the treatment days, including long acting bronchodilators and inhaled corticosteroids.
- Positive COVID-19 test in the prior 90 days.
- Allergy/sensitivity to study drugs or their formulations: Known Immunoglobulin E (IgE) -mediated hypersensitivity to albuterol, diphenhydramine or corticosteroids.
- Physical/laboratory indications:
- Abnormalities on lung auscultation
- Temperature > 37.8
- Systolic BP >150 mm Hg or < 90 mm Hg or diastolic BP> 90 mm Hg or < 50
- Oxygen saturation of < 93%
- Inability or unwillingness of a participant to give written informed consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Environmental Medicine, Asthma and Lung Biology
Chapel Hill, North Carolina, 27599
About this study
Purpose: To determine if inhaled hypertonic saline (HS) accelerates airway mucociliary clearance (MCC) in well-controlled moderate to severe asthmatics.
Read the detailed description
Participants: Non-smoking adults with well controlled moderate to severe asthma
Procedures (methods): After undergoing a general health screen, participants will undergo a lung transmission scan to create an image of the lungs. In subsequent visits, participants will inhale nebulized radiolabeled aerosol and sit in front of a gamma camera for 2 hours to measure clearance of radiolabeled particles from the lungs (procedure called gamma scintigraphy), which will be used to calculate baseline MCC. Spirometry will be performed before and at regular intervals after HS to assess for clinically significant reductions in lung function. Vital signs and symptom questionnaires will be administered as well. If participants are deemed tolerant to HS (i.e., no clinically significant deterioration in lung function, vital signs, or symptom questionnaire scores), participants will move forward with study visits.
- Conditions
- Moderate to Severe Asthma
- Being tested
- 3% Hypertonic Saline, 7% Hypertonic Saline, Salbutamol
- Keywords
- asthma, hypertonic saline
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3% Hypertonic SalineDevice
4 mL of 3% hypertonic saline
7% Hypertonic SalineDevice
4 mL of 7% hypertonic saline
SalbutamolDrug
Also called Albuterol
4 puffs (90 mcg/actuation)
| Study group | Role | What they receive |
|---|---|---|
| Early & Late-Phase Hypertonic Saline (HS) 7% (Cohort 1) | Experimental | Following screening, participants returned 1-6 weeks later and received albuterol alone followed by MCC. After another 1-6 weeks washout, participants then received late phase albuterol + 7% HS 4 hours post MCC. After another 1-6 weeks washout, participants then received albuterol + 7% HS followed by MCC. Five to ten days later participants returned for a discontinuation visit. Receives: Device: 7% Hypertonic Saline; Drug: Salbutamol |
| Hypertonic Saline (HS) 3% and 7% (Cohort 2) | Experimental | Following screening, participants returned 1-6 weeks later and received albuterol plus 3% HS followed by MCC. After another 1-6 weeks washout, participants then received albuterol + 7% HS followed by MCC. Five to ten days later participants returned for a discontinuation visit. Receives: Device: 3% Hypertonic Saline; Device: 7% Hypertonic Saline; Drug: Salbutamol |
| Acute Hypertonic Saline (HS) 7% (Cohort 3) | Experimental | Following screening, participants returned 1-6 weeks later and received albuterol alone followed by MCC. After another 1-6 weeks washout, participants then received albuterol + 7% HS followed by MCC. Five to ten days later participants returned for a discontinuation visit. Receives: Device: 7% Hypertonic Saline; Drug: Salbutamol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in MCC From Baseline to 7% Post Hypertonic Saline Inhalation
This outcome was the primary outcome maintained across the entire study (all cohorts). Smaller cohorts also examined the effect of 7% HS on MCC 4 hours after inhalation (Cohort 1), the effect of 3% HS on MCC immediate inhalation (Cohort 2), and the effect of albuterol alone on MCC (Cohort 3).
Measured: Baseline MCC and at 2-12 weeks later MCC immediately after inhaled 7% HS, within approximately '15' minutes
Secondary outcomes (2)
Effects of Hypertonic Saline on MCC by Testing
The purpose of this outcome during Cohort 1 was to determine if there was a prolonged effect on MCC by 7% HS 4 hours post. Following interim analysis, it was decided that measurement at this timepoint would not be pursued and this outcome was deleted by a protocol amendment.
Measured: Baseline MCC, and 1-6 weeks later (MCC scan administered 4 hours after 7% HS inhalation)
The Proportion of Moderate to Severe Asthmatics Who Are Deemed 'Intolerant' to Hypertonic Saline
A persistent reduction in the forced expiratory volume in one second (FEV1) of greater than or equal to 10% from that day's baseline
Measured: 30 minutes post-Hypertonic Saline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2018
- Study start1 Oct 2018
- Primary completion6 Jun 2024
- Study completion6 Jun 2024
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 Moderate to Severe AsthmaStudies 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
- Non-randomised
- Intervention model
- Sequential
- Model description
- To access the efficacy of inhalation of 3% and 7% hypertonic saline
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- David Peden, MD, MS, Principal investigator, CEMALB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03556683
- Sponsor's protocol ID
- 17-3209
- Other IDs
- 17-0973, 2P01HL108808-06
- Status last verified
- May 2025
- First submitted
- 1 Jun 2018
- Last updated
- 5 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- 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 5 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Assessment of Hypertonic Saline in Moderate to Severe Asthmatics
- ClinicalTrials.gov ID
- NCT03556683
- Acronym / sponsor ID
- 17-3209
- Conditions
- Moderate to Severe Asthma
- Keywords
- asthma, hypertonic saline
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 6 Jun 2024 (actual)
- Study completion
- 6 Jun 2024 (actual)
- First posted
- 14 Jun 2018 (actual)
- Results
- Posted 4 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Purpose: To determine if inhaled hypertonic saline (HS) accelerates airway mucociliary clearance (MCC) in well-controlled moderate to severe asthmatics.
Detailed description
Participants: Non-smoking adults with well controlled moderate to severe asthma
Procedures (methods): After undergoing a general health screen, participants will undergo a lung transmission scan to create an image of the lungs. In subsequent visits, participants will inhale nebulized radiolabeled aerosol and sit in front of a gamma camera for 2 hours to measure clearance of radiolabeled particles from the lungs (procedure called gamma scintigraphy), which will be used to calculate baseline MCC. Spirometry will be performed before and at regular intervals after HS to assess for clinically significant reductions in lung function. Vital signs and symptom questionnaires will be administered as well. If participants are deemed tolerant to HS (i.e., no clinically significant deterioration in lung function, vital signs, or symptom questionnaire scores), participants will move forward with study visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- To access the efficacy of inhalation of 3% and 7% hypertonic saline
| Arm | Type | Receives |
|---|---|---|
| Early & Late-Phase Hypertonic Saline (HS) 7% (Cohort 1) | Experimental | Device: 7% Hypertonic Saline, Drug: SalbutamolFollowing screening, participants returned 1-6 weeks later and received albuterol alone followed by MCC. After another 1-6 weeks washout, participants then received late phase albuterol + 7% HS 4 hours post MCC. After another 1-6 weeks washout, participants then received albuterol + 7% HS followed by MCC. Five to ten days later participants returned for a discontinuation visit. |
| Hypertonic Saline (HS) 3% and 7% (Cohort 2) | Experimental | Device: 3% Hypertonic Saline, Device: 7% Hypertonic Saline, Drug: SalbutamolFollowing screening, participants returned 1-6 weeks later and received albuterol plus 3% HS followed by MCC. After another 1-6 weeks washout, participants then received albuterol + 7% HS followed by MCC. Five to ten days later participants returned for a discontinuation visit. |
| Acute Hypertonic Saline (HS) 7% (Cohort 3) | Experimental | Device: 7% Hypertonic Saline, Drug: SalbutamolFollowing screening, participants returned 1-6 weeks later and received albuterol alone followed by MCC. After another 1-6 weeks washout, participants then received albuterol + 7% HS followed by MCC. Five to ten days later participants returned for a discontinuation visit. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age 18-60 of both genders-
- Moderate to severe asthma at baseline (determined by Step 3 therapy or greater or by asthma impairment) and well-controlled asthma at the time of enrollment, as determined by NHLBI Expert Panel Report 3 guidelines for diagnosis and treatment of asthma.
- Negative pregnancy test for females who are not s/p hysterectomy with oophorectomy.
- Forced expiratory volume in 1 sec (FEV1) of at least 70% of predicted for age, sex, height, and race/ethnicity (without use of bronchodilating medications for 12 hours or long acting beta agonists for 24 hours).
- Documented COVID-19 vaccination
Key exclusion criteria (23 listed)
- Subjects who meet any of these criteria are not eligible for enrollment as study participants:
- Clinical Contraindications:
- Any chronic medical condition considered by the PI as a contraindication to the study including significant cardiovascular disease, diabetes, chronic renal disease, chronic thyroid disease, history of chronic infections/immunodeficiency, or history of tuberculosis Any acute infection requiring antibiotics within 4 weeks of study. Mental illness or history of drug or alcohol abuse that, in the opinion of the investigator, would interfere with the participant's ability to comply with study requirements.
- Medications which may impact the results of the study treatment, or may interfere with any other medications potentially used in the study (to include steroids, beta antagonists, non-steroidal anti-inflammatory agents) Active smoking to include e-cigarettes within 1 year of the study, or lifetime of > 10 pack-years of smoking Allergy/sensitivity to study drugs, or their formulations. History of intubation for asthma Unwillingness to use reliable contraception if sexually active (birth control pills/patch, condoms).
- Viral upper respiratory tract infection within 4 weeks of challenge. Radiation exposure history in the past year that would cause the participant to exceed Federal radiation safety guidelines.
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 |
|---|---|---|
| 3% Hypertonic Saline4 mL of 3% hypertonic saline | Device | Hypertonic Saline (HS) 3% and 7% (Cohort 2) |
| 7% Hypertonic Saline4 mL of 7% hypertonic saline | Device | Acute Hypertonic Saline (HS) 7% (Cohort 3), Early & Late-Phase Hypertonic Saline (HS) 7% (Cohort 1), Hypertonic Saline (HS) 3% and 7% (Cohort 2) |
| SalbutamolAlso: Albuterol4 puffs (90 mcg/actuation) | Drug | Acute Hypertonic Saline (HS) 7% (Cohort 3), Early & Late-Phase Hypertonic Saline (HS) 7% (Cohort 1), Hypertonic Saline (HS) 3% and 7% (Cohort 2) |
Primary outcome
Change in MCC From Baseline to 7% Post Hypertonic Saline Inhalation
Time frame: Baseline MCC and at 2-12 weeks later MCC immediately after inhaled 7% HS, within approximately '15' minutes
This outcome was the primary outcome maintained across the entire study (all cohorts). Smaller cohorts also examined the effect of 7% HS on MCC 4 hours after inhalation (Cohort 1), the effect of 3% HS on MCC immediate inhalation (Cohort 2), and the effect of albuterol alone on MCC (Cohort 3).
2 secondary outcomes
Effects of Hypertonic Saline on MCC by Testing
Time frame: Baseline MCC, and 1-6 weeks later (MCC scan administered 4 hours after 7% HS inhalation)
The Proportion of Moderate to Severe Asthmatics Who Are Deemed 'Intolerant' to Hypertonic Saline
Time frame: 30 minutes post-Hypertonic Saline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2025.
- 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.
David Peden, MD, MS principal investigator
CEMALB
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3% Hypertonic Saline, 7% Hypertonic Saline and Salbutamol in people with Moderate to Severe Asthma, 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 23 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 5 Aug 2025. 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 May 2025). 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 MCC From Baseline to 7% Post Hypertonic Saline Inhalation (time frame: Baseline MCC and at 2-12 weeks later MCC immediately after inhaled 7% HS, within approximately '15' minutes). 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 5 Aug 2025.