Phase I Assessment of Hypertonic Saline in Moderate to Severe Asthmatics

  • STATUS
    Recruiting
  • End date
    Jul 22, 2023
  • participants needed
    24
  • sponsor
    University of North Carolina, Chapel Hill
Updated on 22 March 2022

Summary

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

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.

Details
Condition Moderate to Severe Asthma
Treatment Hypertonic saline, 3% hypertonic saline, 7% Hypertonic Saline
Clinical Study IdentifierNCT03556683
SponsorUniversity of North Carolina, Chapel Hill
Last Modified on22 March 2022

Eligibility

Yes No Not Sure

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
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
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 LAIV (Live Attenuated Influenza Vaccine), also known as FluMist®
Non-steroidal anti-inflammatory drugs in the 4 days prior to the treatment visit
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
Physical/laboratory indications
Subjects must be able to withhold morning doses of maintenance inhalers on the
Abnormalities on lung auscultation
treatment days, including long acting bronchodilators and inhaled
Temperature > 37.8
Systolic BP >150 mm Hg or < 90 mm Hg or diastolic BP> 90 mm Hg or < 50
corticosteroids
Oxygen saturation of < 93%
Positive Covid 19 test in the prior 90 days
Inability or unwillingness of a participant to give written informed consent
Allergy/sensitivity to study drugs or their formulations: Known IgE-(Immunoglobulin E)
mediated hypersensitivity to albuterol, diphenhydramine or corticosteroids
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note