Trial Outcomes & Findings for Inhaled Xylitol Versus Saline in Stable Subjects With Cystic Fibrosis (NCT NCT01355796)

NCT ID: NCT01355796

Last Updated: 2018-10-24

Results Overview

Change from baseline in FEV1(maximal amount of air you can forcefully exhale in one second) % predicted

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 30 participants
• Primary outcome timeframe: Baseline and 14 days
• Results posted on: 2018-10-24

Participant Flow

Participant milestones

Measure	Xylitol First Then Saline Drug Xylitol: Aerosolized 15% xylitol, 5 ml twice a day for 14 days Xylo-pentane-1,2,3,4 5-pentol: 5 ml of 15 % aerosolized 2 times per day Saline: Hypersal: Hypertonic saline 7%, 4 ml twice a day for 14 days	Saline First and Then Xylitol Aerosolized 7% hypertonic saline (4 ml) twice daily for 14 days Xylitol: Aerosolized 15% xylitol, 5 ml twice a day for 2 weeks Xylo-pentane-1,2,3,4 5-pentol: 5 ml of 15 % aerosolized 2 times per day
Overall Study STARTED	15	15
Overall Study First Intervention for 14 Days	15	15
Overall Study Washout Period for 7 Days	15	15
Overall Study Second Intervention for 14 Days	15	15
Overall Study COMPLETED	15	15
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Inhaled Xylitol Versus Saline in Stable Subjects With Cystic Fibrosis

Baseline characteristics by cohort

Measure	All Participants n=30 Participants Baseline characteristics of the entire study cohort
Age, Categorical <=18 years	4 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	26 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	31 years STANDARD_DEVIATION 12.56 • n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants
Region of Enrollment United States	30 participants n=5 Participants
FEV1	71 % of predicted n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 14 days

Change from baseline in FEV1(maximal amount of air you can forcefully exhale in one second) % predicted

Outcome measures

Measure	Xylitol n=30 Participants Drug Aerosolized xylitol (5 ml) twice daily for 14 days Xylitol: Aerosolized 15% xylitol, 5 ml twice a day for 2 weeks, Xylo-pentane-1,2,3,4 5-pentol: 5 ml of 15 % aerosolized 2 times per day	Saline n=30 Participants Hypersal, 7%, 4 ml BID
Change in FEV1 % Predicted From Baseline	-0.1 percentage of predicted Interval -2.4 to 2.2	1.4 percentage of predicted Interval -0.92 to 3.7

SECONDARY outcome

Timeframe: baseline and 14 days

Population: 27 out of 30 subjects were able to give sputum on day 14 and only those subjects are included in this analysis

Difference from baseline in density of Pseudomonas aeruginosa colonization per gram of sputum,

Outcome measures

Measure	Xylitol n=27 Participants Drug Aerosolized xylitol (5 ml) twice daily for 14 days Xylitol: Aerosolized 15% xylitol, 5 ml twice a day for 2 weeks, Xylo-pentane-1,2,3,4 5-pentol: 5 ml of 15 % aerosolized 2 times per day	Saline n=27 Participants Hypersal, 7%, 4 ml BID
Sputum Density	-1.98 Log colony forming units Interval -4.07 to 0.11	0.93 Log colony forming units Interval -0.9 to 2.77

Adverse Events

Aerosolized Hypertonic Xyltiol

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Hypertonic Saline

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Measure	Aerosolized Hypertonic Xyltiol n=30 participants at risk Drug Aerosolized xylitol (5 ml) twice daily for 14 days Xylitol: Aerosolized 15% xylitol, 5 ml twice a day for 2 weeks Xylo-pentane-1,2,3,4 5-pentol: 5 ml of 15 % aerosolized 2 times per day	Hypertonic Saline n=30 participants at risk Aerosolized 7% hypertonic saline (4 ml) twice daily for 14 days Xylitol: Aerosolized 15% xylitol, 5 ml twice a day for 2 weeks Xylo-pentane-1,2,3,4 5-pentol: 5 ml of 15 % aerosolized 2 times per day
Respiratory, thoracic and mediastinal disorders pneumonia	0.00% 0/30 • Average of 21 days (14 days of study drug use and 7 days after the last study drug use.	3.3% 1/30 • Number of events 1 • Average of 21 days (14 days of study drug use and 7 days after the last study drug use.

Other adverse events

Measure	Aerosolized Hypertonic Xyltiol n=30 participants at risk Drug Aerosolized xylitol (5 ml) twice daily for 14 days Xylitol: Aerosolized 15% xylitol, 5 ml twice a day for 2 weeks Xylo-pentane-1,2,3,4 5-pentol: 5 ml of 15 % aerosolized 2 times per day	Hypertonic Saline n=30 participants at risk Aerosolized 7% hypertonic saline (4 ml) twice daily for 14 days Xylitol: Aerosolized 15% xylitol, 5 ml twice a day for 2 weeks Xylo-pentane-1,2,3,4 5-pentol: 5 ml of 15 % aerosolized 2 times per day
Nervous system disorders headache	3.3% 1/30 • Number of events 1 • Average of 21 days (14 days of study drug use and 7 days after the last study drug use.	3.3% 1/30 • Number of events 1 • Average of 21 days (14 days of study drug use and 7 days after the last study drug use.

Additional Information

Janice Launspach

University of Iowa

Phone: 319-356-2047

Email: janice-launspach@uiowa.edu

Results disclosure agreements

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