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Phase I Assessment of Hypertonic Saline in Moderate to Severe Asthmatics

NCT03556683 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2025-08-05

Study results available
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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

Interventions

DEVICE

3% Hypertonic Saline

4 mL of 3% hypertonic saline

DEVICE

7% Hypertonic Saline

4 mL of 7% hypertonic saline

DRUG

Salbutamol

4 puffs (90 mcg/actuation)

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • University of North Carolina, Chapel Hill

    lead OTHER

Principal Investigators

  • David Peden, MD, MS · CEMALB

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-01
Primary Completion
2024-06-06
Completion
2024-06-06
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03556683 on ClinicalTrials.gov