Trial Outcomes & Findings for Phase I Assessment of Hypertonic Saline in Moderate to Severe Asthmatics (NCT NCT03556683)
NCT ID: NCT03556683
Last Updated: 2025-08-05
Results Overview
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).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
24 participants
Primary outcome timeframe
Baseline MCC and at 2-12 weeks later MCC immediately after inhaled 7% HS, within approximately '15' minutes
Results posted on
2025-08-05
Participant Flow
This exploratory study sought to determine the efficacy of 7% Hypertonic Saline (HS) for accelerating MCC acutely compared to baseline. Multiple cohorts evolved based on preliminary findings. Each cohort consisted of a Baseline MCC scan and albuterol+7% HS nebulization followed by MCC. In addition, differences in each cohort are as follows: cohort 1 late-phase 7% HS was assessed and in cohort 2, acute 3% HS was assessed and in cohort 3 acute albuterol alone was assessed.
Participant milestones
| Measure |
Early & Late-Phase Hypertonic Saline (HS) 7% (Cohort 1)
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.
7% Hypertonic Saline: 4 mL of 7% hypertonic saline Salbutamol: 4 puffs (90 mcg/actuation), Albuterol
|
Hypertonic Saline (HS) 3% and 7% (Cohort 2)
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.
7% Hypertonic Saline: 4 mL of 7% hypertonic saline 3% Hypertonic Saline: 4 mL of 3% hypertonic saline Salbutamol: 4 puffs (90 mcg/actuation), Albuterol
|
Acute Hypertonic Saline (HS) 7% (Cohort 3)
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.
7% Hypertonic Saline: 4 mL of 7% hypertonic saline Salbutamol: 4 puffs (90 mcg/actuation), Albuterol
|
|---|---|---|---|
|
Overall Study
STARTED
|
10
|
8
|
6
|
|
Overall Study
COMPLETED
|
9
|
7
|
6
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase I Assessment of Hypertonic Saline in Moderate to Severe Asthmatics
Baseline characteristics by cohort
| Measure |
Early & Late-Phase Hypertonic Saline (HS) 7% (Cohort 1)
n=10 Participants
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.
7% Hypertonic Saline: 4 mL of 7% hypertonic saline Salbutamol: 4 puffs (90 mcg/actuation), Albuterol
|
Hypertonic Saline (HS) 3% and 7% (Cohort 2)
n=8 Participants
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.
7% Hypertonic Saline: 4 mL of 7% hypertonic saline 3% Hypertonic Saline: 4 mL of 3% hypertonic saline Salbutamol: 4 puffs (90 mcg/actuation), Albuterol
|
Acute Hypertonic Saline (HS) 7% (Cohort 3)
n=6 Participants
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.
7% Hypertonic Saline: 4 mL of 7% hypertonic saline Salbutamol: 4 puffs (90 mcg/actuation), Albuterol
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline MCC and at 2-12 weeks later MCC immediately after inhaled 7% HS, within approximately '15' minutesPopulation: This outcome was the only outcome assessed across all cohorts of the study evaluating both the effect and tolerability of 7% HS immediately after inhalation. This is the most effective clinically relevant timepoint for effect and tolerability. For this endpoint, considering the entire sample size together was considered the most statistically sound way to report this outcome.
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).
Outcome measures
| Measure |
Hypertonic Saline
n=22 Participants
Subjects will inhale hypertonic saline before having a Mucociliary Clearance (MCC) scan
3% Hypertonic Saline: 4 mL of 3% hypertonic saline
7% Hypertonic Saline: 4 mL of 7% hypertonic saline
|
Hypertonic Saline (HS) 3% and 7% (Cohort 2)
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.
7% Hypertonic Saline: 4 mL of 7% hypertonic saline 3% Hypertonic Saline: 4 mL of 3% hypertonic saline Salbutamol: 4 puffs (90 mcg/actuation), Albuterol
|
Acute Hypertonic Saline (HS) 7% (Cohort 3)
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.
7% Hypertonic Saline: 4 mL of 7% hypertonic saline Salbutamol: 4 puffs (90 mcg/actuation), Albuterol
|
|---|---|---|---|
|
Change in MCC From Baseline to 7% Post Hypertonic Saline Inhalation
|
29.9 percent clearance
Standard Deviation 7.9
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline MCC, and 1-6 weeks later (MCC scan administered 4 hours after 7% HS inhalation)Population: Only 9 participants underwent study for 4-hour effect of Hypertonic Saline which was only studied in Cohort 1.
The purpose of this outcome during Cohort 1 was to determine if there was a prolonged effect on MCC by 7% HS 4 hours post. Following interim analysis, it was decided that measurement at this timepoint would not be pursued and this outcome was deleted by a protocol amendment.
Outcome measures
| Measure |
Hypertonic Saline
n=9 Participants
Subjects will inhale hypertonic saline before having a Mucociliary Clearance (MCC) scan
3% Hypertonic Saline: 4 mL of 3% hypertonic saline
7% Hypertonic Saline: 4 mL of 7% hypertonic saline
|
Hypertonic Saline (HS) 3% and 7% (Cohort 2)
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.
7% Hypertonic Saline: 4 mL of 7% hypertonic saline 3% Hypertonic Saline: 4 mL of 3% hypertonic saline Salbutamol: 4 puffs (90 mcg/actuation), Albuterol
|
Acute Hypertonic Saline (HS) 7% (Cohort 3)
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.
7% Hypertonic Saline: 4 mL of 7% hypertonic saline Salbutamol: 4 puffs (90 mcg/actuation), Albuterol
|
|---|---|---|---|
|
Effects of Hypertonic Saline on MCC by Testing
|
11.8 Percent clearance
Standard Deviation 8.3
|
—
|
—
|
SECONDARY outcome
Timeframe: 30 minutes post-Hypertonic SalinePopulation: This procedure was only done for Cohort 1. Data are reported for the 9 participants who completed the procedure.
A persistent reduction in the forced expiratory volume in one second (FEV1) of greater than or equal to 10% from that day's baseline
Outcome measures
| Measure |
Hypertonic Saline
n=9 Participants
Subjects will inhale hypertonic saline before having a Mucociliary Clearance (MCC) scan
3% Hypertonic Saline: 4 mL of 3% hypertonic saline
7% Hypertonic Saline: 4 mL of 7% hypertonic saline
|
Hypertonic Saline (HS) 3% and 7% (Cohort 2)
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.
7% Hypertonic Saline: 4 mL of 7% hypertonic saline 3% Hypertonic Saline: 4 mL of 3% hypertonic saline Salbutamol: 4 puffs (90 mcg/actuation), Albuterol
|
Acute Hypertonic Saline (HS) 7% (Cohort 3)
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.
7% Hypertonic Saline: 4 mL of 7% hypertonic saline Salbutamol: 4 puffs (90 mcg/actuation), Albuterol
|
|---|---|---|---|
|
The Proportion of Moderate to Severe Asthmatics Who Are Deemed 'Intolerant' to Hypertonic Saline
|
0 proportion participants
|
—
|
—
|
Adverse Events
Early & Late-Phase Hypertonic Saline (HS) 7% (Cohort 1)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Hypertonic Saline (HS) 3% and 7% (Cohort 2)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Acute Hypertonic Saline (HS) 7% (Cohort 3)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Early & Late-Phase Hypertonic Saline (HS) 7% (Cohort 1)
n=10 participants at risk
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.
7% Hypertonic Saline: 4 mL of 7% hypertonic saline Salbutamol: 4 puffs (90 mcg/actuation), Albuterol
|
Hypertonic Saline (HS) 3% and 7% (Cohort 2)
n=8 participants at risk
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.
7% Hypertonic Saline: 4 mL of 7% hypertonic saline 3% Hypertonic Saline: 4 mL of 3% hypertonic saline Salbutamol: 4 puffs (90 mcg/actuation), Albuterol
|
Acute Hypertonic Saline (HS) 7% (Cohort 3)
n=6 participants at risk
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.
7% Hypertonic Saline: 4 mL of 7% hypertonic saline Salbutamol: 4 puffs (90 mcg/actuation), Albuterol
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Infection
|
10.0%
1/10 • Number of events 1 • From the time of signing informed consent through study completion, up to approximately 3.5 months
|
12.5%
1/8 • Number of events 1 • From the time of signing informed consent through study completion, up to approximately 3.5 months
|
0.00%
0/6 • From the time of signing informed consent through study completion, up to approximately 3.5 months
|
|
Vascular disorders
Mild Headache
|
10.0%
1/10 • Number of events 1 • From the time of signing informed consent through study completion, up to approximately 3.5 months
|
0.00%
0/8 • From the time of signing informed consent through study completion, up to approximately 3.5 months
|
0.00%
0/6 • From the time of signing informed consent through study completion, up to approximately 3.5 months
|
Additional Information
Carole Robinette
University of North Carolina at Chapel Hill
Phone: 919-966-5638
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place