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Phase I Assessment of Hypertonic Saline in Moderate to Severe Asthmatics

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ClinicalTrials.gov Identifier: NCT03556683
Recruitment Status : Recruiting
First Posted : June 14, 2018
Last Update Posted : January 9, 2023
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Brief Summary:
Purpose: To determine if inhaled hypertonic saline (HS) accelerates airway mucociliary clearance (MCC) in well-controlled moderate to severe asthmatics.

Condition or disease Intervention/treatment Phase
Moderate to Severe Asthma Device: 3% Hypertonic Saline Device: 7% Hypertonic Saline Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: N/A
Intervention Model: Sequential Assignment
Intervention Model Description: To access the efficacy of inhalation of 3% and 7% hypertonic saline
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Assessment of Hypertonic Saline in Moderate to Severe Asthmatics
Actual Study Start Date : October 1, 2018
Estimated Primary Completion Date : July 2023
Estimated Study Completion Date : July 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Experimental: Hypertonic Saline
Subjects will inhale hypertonic saline before having a Mucociliary Clearance (MCC) scan
Device: 3% Hypertonic Saline
4 mL of 3% hypertonic saline

Device: 7% Hypertonic Saline
4 mL of 7% hypertonic saline

Primary Outcome Measures :
  1. Change in MCC from Baseline to Post Hypertonic Saline Inhalation [ Time Frame: Baseline, immediately after inhaled Hypertonic Saline, within approximately '15' minutes ]

Secondary Outcome Measures :
  1. Effects of HS on MCC by testing [ Time Frame: Baseline, 4 hours after Hypertonic Saline ]
    Following interim analysis, measurement at this timepoint will not be pursued. This outcome is being deleted by a protocol amendment.

  2. The proportion of moderate to severe asthmatics who are deemed 'intolerant' to HS [ Time Frame: 30 minutes post-HS ]
    A persistent reduction in FEV1 of greater than or equal to 10% from that day's baseline

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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.
  • FEV1 (forced expiratory volume 1 sec) 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

Exclusion Criteria:

Subjects who meet any of these criteria are not eligible for enrollment as study participants:

  1. 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.

  2. 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.
  3. Use of the following medications:

    1. 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.
    2. Use of daily theophylline within the past month
    3. Use of any immunosuppressant/immunomodulatory therapy within the preceding 12 months
    4. Use of beta blocking medications
    5. Receipt of LAIV (Live Attenuated Influenza Vaccine), also known as FluMist®, within the prior 30 days, or any vaccine within the prior 5 days
    6. Multivitamins, Vitamin C or E or herbal medications in the 4 days prior to the treatment visit
    7. Non-steroidal anti-inflammatory drugs in the 4 days prior to the treatment visit
    8. Subjects must be able to withhold morning doses of maintenance inhalers on the treatment days, including long acting bronchodilators and inhaled corticosteroids.
    9. Positive Covid 19 test in the prior 90 days.
  4. Allergy/sensitivity to study drugs or their formulations: Known IgE-(Immunoglobulin E) mediated hypersensitivity to albuterol, diphenhydramine or corticosteroids.
  5. Physical/laboratory indications:

    1. Abnormalities on lung auscultation
    2. Temperature > 37.8
    3. Systolic BP >150 mm Hg or < 90 mm Hg or diastolic BP> 90 mm Hg or < 50
    4. Oxygen saturation of < 93%
  6. Inability or unwillingness of a participant to give written informed consent.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03556683

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Contact: Martha Almond 919-966-0759 martha_almond@med.unc.edu

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United States, North Carolina
Center for Environmental Medicine, Asthma and Lung Biology Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Research Coordinator    919-966-0759    martha_almond@med.unc.edu   
Sponsors and Collaborators
University of North Carolina, Chapel Hill
National Heart, Lung, and Blood Institute (NHLBI)
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Principal Investigator: David Peden, MD, MS CEMALB
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Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT03556683    
Other Study ID Numbers: 17-3209
17-0973 ( Other Identifier: UNC RAMSES Number )
2P01HL108808-06 ( U.S. NIH Grant/Contract )
First Posted: June 14, 2018    Key Record Dates
Last Update Posted: January 9, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by University of North Carolina, Chapel Hill:
asthma, hypertonic saline
Additional relevant MeSH terms:
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Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases