Phase I Assessment of Hypertonic Saline in Moderate to Severe Asthmatics

This is an interventional treatment trial for Moderate to Severe Asthma focused on measuring asthma, hypertonic saline Read More

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.