Trial Outcomes & Findings for Detection of Pseudomonas Aeruginosa in the Airways of Patients With CF (NCT NCT01303068)

Results Overview

The primary endpoint is the safety of inhaled 13C urea assessed by adverse events including pulmonary findings and changes from baseline in physical examination findings, pulse oximetry results, pulmonary function test results, and vital signs.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

12 participants

Primary outcome timeframe

6 hours

Results posted on

2024-01-30

Participant Flow

Participant milestones

Participant milestones
Measure	CF Patients, 13C Urea Breath Test Kit CF patients with Pseudomonas infection tested with 13C urea breath test 13C urea breath test Kit: 20 and 50 mg, 13C urea breath test: urea nebulizer solution to detect Pseudomonas	Healthy Subjects Using 13C Urea Breath Test Kit Healthy subjects using 13C urea breath test kit 13C urea breath test Kit: 20 and 50 mg, 13C urea breath test: urea nebulizer solution to detect Pseudomonas
Overall Study STARTED	6	6
Overall Study COMPLETED	6	6
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Detection of Pseudomonas Aeruginosa in the Airways of Patients With CF

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CF Patients, 13C Urea Breath Test Kit n=6 Participants CF patients with Pseudomonas infection tested with 13C urea breath test 13C urea breath test Kit: 20 and 50 mg, 13C urea breath test: urea nebulizer solution to detect Pseudomonas	Healthy Controls, 13C Urea Breath Test Kit n=6 Participants Healthy subjects using 13C urea breath test kit 13C urea breath test Kit: 20 and 50 mg, 13C urea breath test: urea nebulizer solution to detect Pseudomonas	Total n=12 Participants Total of all reporting groups
Age, Continuous	26 years n=5 Participants	32 years n=7 Participants	29 years n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 hours

The primary endpoint is the safety of inhaled 13C urea assessed by adverse events including pulmonary findings and changes from baseline in physical examination findings, pulse oximetry results, pulmonary function test results, and vital signs.

Outcome measures

Outcome measures
Measure	CF Patients, 13C Urea Breath Test Kit n=6 Participants CF patients with Pseudomonas infection tested with 13C urea breath test 13C urea breath test Kit: 20 and 50 mg, 13C urea breath test: urea nebulizer solution to detect Pseudomonas	Healthy Subjects Using 13C Urea Breath Test Kit n=6 Participants Healthy subjects using 13C urea breath test kit 13C urea breath test Kit: 20 and 50 mg, 13C urea breath test: urea nebulizer solution to detect Pseudomonas
The Primary Objective is to Assess the Safety of 13C Urea Administered by Inhalation.	0 adverse events	0 adverse events

SECONDARY outcome

Timeframe: 5 minutes post inhalation

Population: CF patients with infection has a higher 13C urea in their exhaled breath.

Secondary endpoints are the isotopic ratios of 13C to 12C in exhaled carbon dioxide measured with the POCone detector (Meretek Diagnostics Group of Otsuka America Pharmaceutical, Rockville, MD) at 5, 10, and 15 minutes after study drug administration.

Outcome measures

Outcome measures
Measure	CF Patients, 13C Urea Breath Test Kit n=6 Participants CF patients with Pseudomonas infection tested with 13C urea breath test 13C urea breath test Kit: 20 and 50 mg, 13C urea breath test: urea nebulizer solution to detect Pseudomonas	Healthy Subjects Using 13C Urea Breath Test Kit n=6 Participants Healthy subjects using 13C urea breath test kit 13C urea breath test Kit: 20 and 50 mg, 13C urea breath test: urea nebulizer solution to detect Pseudomonas
The Secondary Objective is to Assess the Kinetics of 13C Carbon Dioxide Production by Measuring the Isotopic Ratio of 13C to 12C in Exhaled Carbon Dioxide. 20 mg	4 ratio Interval 2.2 to 4.9	0.8 ratio Interval 0.4 to 1.2
The Secondary Objective is to Assess the Kinetics of 13C Carbon Dioxide Production by Measuring the Isotopic Ratio of 13C to 12C in Exhaled Carbon Dioxide. 50 mg	10 ratio Interval 6.2 to 14.5	2.13 ratio Interval 0.1 to 5.5

Adverse Events

CF Patients, 13C Urea Breath Test Kit

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Healthy Subjects Using 13C Urea Breath Test Kit

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

Hengameh Raissy

University of New Mexico

Phone: 5052725484

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place