Phase I Assessment of Hypertonic Saline in Moderate to Severe Asthmatics
Moderate to Severe Asthma
Bottom Line
View on ClinicalTrials.gov: NCT03556683 ↗Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- 3% Hypertonic Saline (Device); 7% Hypertonic Saline (Device); Salbutamol (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of North Carolina, Chapel Hill
- Primary completion
- Jun 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in MCC From Baseline to 7% Post Hypertonic Saline Inhalation |
29.9 | <0.001 sig |
| SECONDARY Effects of Hypertonic Saline on MCC by Testing |
11.8 | 0.99 |
| SECONDARY The Proportion of Moderate to Severe Asthmatics Who Are Deemed 'Intolerant' to Hypertonic Saline |
— | — |
Summary
Eligibility Criteria
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.
- 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
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 ( 37.8
- Systolic BP >150 mm Hg or 90 mm Hg or < 50
- Oxygen saturation of < 93%
- Inability or unwillingness of a participant to give written informed consent.
Data sourced from ClinicalTrials.gov (NCT03556683). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.