Trial Outcomes & Findings for Hypertonic Saline and Mucociliary Clearance in Children (NCT NCT01293084)

NCT ID: NCT01293084

Last Updated: 2015-09-22

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 17 participants
• Primary outcome timeframe: 60 minutes
• Results posted on: 2015-09-22

Participant Flow

Data could not be retrieved for the order of randomization.

Participant milestones

Measure	Children With CF Children with CF inhaled either 5 mL of 7% saline or 0.12% saline once over 20 minutes. On a second visit, the same children were crossed-over and inhaled either 0.12% saline or 7% saline over 20 minutes. The order of these visits was randomized but the sequence of the randomization is not known.
Overall Study STARTED	17
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Measure	Children With CF Children with CF inhaled either 5 mL of 7% saline or 0.12% saline once over 20 minutes. On a second visit, the same children were crossed-over and inhaled either 0.12% saline or 7% saline over 20 minutes. The order of these visits was randomized but the sequence of the randomization is not known.
Overall Study Physician Decision	3
Overall Study Withdrawal by Subject	2

Baseline Characteristics

Hypertonic Saline and Mucociliary Clearance in Children

Baseline characteristics by cohort

Measure	Children With CF n=12 Participants Children with CF inhaled either 5 mL of 7% saline or 0.12% saline once over 20 minutes. On a second visit, the same children were crossed-over and inhaled either 0.12% saline or 7% saline over 20 minutes. The order of these visits was randomized but the sequence of the randomization is not known.
Age, Continuous	10.5 years n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants
FVC (% predicted)	107 percent predicted n=5 Participants
FEV1 (% predicted)	108 percent predicted n=5 Participants
Genotype F508del homozygous	9 participants n=5 Participants
Genotype F508heterozygous	2 participants n=5 Participants
Genotype Other	1 participants n=5 Participants

PRIMARY outcome

Timeframe: 60 minutes

Population: Participants that completed received both 7% saline and 0.12% saline over the duration of the study

Outcome measures

Measure	7% Saline n=12 Participants 5 mL of 7% saline was inhaled once over a 20 minute period. 7% saline: 5mL 7% saline inhaled once over 20 minutes	0.12% Saline n=12 Participants 5mL 0.12% saline inhaled once during 20 minutes 0.12% saline: 5mL of 0.12% saline inhaled once over 20 minutes
Percent Mucociliary Clearance at 60 Minutes	18.6 percentage mucociliary clearance Interval 12.3 to 27.4	15.4 percentage mucociliary clearance Interval 12.4 to 24.5

SECONDARY outcome

Timeframe: 90 minutes

Population: Data for participants that completed and received both 7% saline and 0.12% saline.

Outcome measures

Measure	7% Saline n=12 Participants 5 mL of 7% saline was inhaled once over a 20 minute period. 7% saline: 5mL 7% saline inhaled once over 20 minutes	0.12% Saline n=12 Participants 5mL 0.12% saline inhaled once during 20 minutes 0.12% saline: 5mL of 0.12% saline inhaled once over 20 minutes
Percent Mucociliary Clearance at 90 Minutes	27.4 percentage mucociliary clearance Interval 16.25 to 30.95	19.3 percentage mucociliary clearance Interval 17.3 to 27.8

Adverse Events

7% Saline

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

0.12% Saline

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

Beth Laube Professor

Johns Hopkins Univeristy

Phone: 410-502-5791

Email: blaube@jhmi.edu

Results disclosure agreements

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