Phase I Assessment of Hypertonic Saline in Moderate to Severe Asthmatics

NCT03556683 | Completed Results DMC FDA Device

• 3 other identifiers: 17-320917-09732P01HL108808-06
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Moderate to Severe Asthma

Keywords

asthma, hypertonic saline

Outcome Measures

Primary Outcomes (1)

• 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).

  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

  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

  30 minutes post-Hypertonic Saline

Study Arms (3)

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.

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.

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.

Device: 7% Hypertonic Saline; Drug: Salbutamol

Interventions

3% Hypertonic Saline DEVICE

4 mL of 3% hypertonic saline

Hypertonic Saline (HS) 3% and 7% (Cohort 2)

7% Hypertonic Saline DEVICE

4 mL of 7% hypertonic saline

Acute Hypertonic Saline (HS) 7% (Cohort 3); Early & Late-Phase Hypertonic Saline (HS) 7% (Cohort 1); Hypertonic Saline (HS) 3% and 7% (Cohort 2)

Salbutamol DRUG

4 puffs (90 mcg/actuation)

Also known as: Albuterol

Acute Hypertonic Saline (HS) 7% (Cohort 3); Early & Late-Phase Hypertonic Saline (HS) 7% (Cohort 1); Hypertonic Saline (HS) 3% and 7% (Cohort 2)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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 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.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Center for Environmental Medicine, Asthma and Lung Biology

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Asthma

Interventions

Albuterol

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines

Results Point of Contact

• Title: Carole Robinette
• Organization: University of North Carolina at Chapel Hill

carole_robinette@med.unc.edu

919-966-5638

Study Officials

• David Peden, MD, MS

  CEMALB

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: To access the efficacy of inhalation of 3% and 7% hypertonic saline

Study Record Dates

• First Submitted: June 1, 2018
• First Posted: June 14, 2018
• Study Start: October 1, 2018
• Primary Completion: June 6, 2024
• Study Completion: June 6, 2024
• Last Updated: August 5, 2025
• Results First Posted: May 4, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)