Trial Outcomes & Findings for Study to Characterize the Durability of Hypertonic Saline to Enhance Mucociliary Clearance in Healthy Subjects (NCT NCT01617369)

NCT ID: NCT01617369

Last Updated: 2017-05-04

Results Overview

The primary outcome of mucociliary clearance (MCC) will be depicted by calculating the average rate of isotope clearance (%) from the whole lung compartment, measured for 90 minutes after isotope inhalation (MCC-Ave 90), using data points collected every 10 minutes. Absolute change in MCC-Ave90 from baseline reported for each arm

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 12 participants
• Primary outcome timeframe: 30 minutes and 4 hours after inhalation
• Results posted on: 2017-05-04

Participant Flow

Participant milestones

Measure	Hypertonic Saline 2.8% NaCl Hypertonic Saline: 2.8% NaCl x 4ml via nebulizer
Overall Study STARTED	12
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study to Characterize the Durability of Hypertonic Saline to Enhance Mucociliary Clearance in Healthy Subjects

Baseline characteristics by cohort

Measure	Hypertonic Saline n=12 Participants 2.8% NaCl Hypertonic Saline: 2.8% NaCl x 4ml via nebulizer
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	31.5 years n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	7 Participants n=5 Participants
Race/Ethnicity, Customized East Asian	0 Participants n=5 Participants
Race/Ethnicity, Customized Black/African American	3 Participants n=5 Participants
Race/Ethnicity, Customized West Asian	0 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	2 Participants n=5 Participants
Race/Ethnicity, Customized Other, Specify	0 Participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants
Current Smoker	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 30 minutes and 4 hours after inhalation

Population: Per Protocol

The primary outcome of mucociliary clearance (MCC) will be depicted by calculating the average rate of isotope clearance (%) from the whole lung compartment, measured for 90 minutes after isotope inhalation (MCC-Ave 90), using data points collected every 10 minutes.

Absolute change in MCC-Ave90 from baseline reported for each arm

Outcome measures

Measure	Acute Hypertonic Saline Effect n=12 Participants 2.8% NaCl inhaled 30 minutes before MCC scan performed Hypertonic Saline: 2.8% NaCl x 4ml via Pari LC STAR jet nebulizer	Sustained Hypertonic Saline Effect n=12 Participants 2.8% NaCl Inhaled 4 hours before mucociliary clearance measured Hypertonic saline = 2.8% NaCl x 4 ml delivered via Pari LC STAR jet nebulizer
Change in Whole Lung Mucociliary Clearance	0.6 % Clearance Standard Deviation 6.4	-4.0 % Clearance Standard Deviation 5.5

Adverse Events

Acute Hypertonic Saline Effect

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sustained Hypertonic Saline Effect

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Scott Donaldson

University of North Carolina Chapel Hill

Phone: 919-966-9198

Email: scott_donaldson@med.unc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60