Trial Outcomes & Findings for Utilizing Exhaled Breathe Condensate Collection to Study Ion Regulation in Cystic Fibrosis (NCT NCT01880723)

Results Overview

We collected exhaled breath condensate (EBC) samples, with subjects breathing on a Jaeger EcoScreen for 20 minutes. EBC samples were collected in cystic fibrosis and healthy subjects before and 30-, 60-, and 90-minutes following albuterol administration.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

32 participants

Primary outcome timeframe

up to 90-minutes post albuterol

Results posted on

2023-11-29

Participant Flow

Participant milestones

Participant milestones
Measure	Healthy Healthy control subjects	Cystic Fibrosis Patients diagnosed with cystic fibrosis
Overall Study STARTED	16	16
Overall Study COMPLETED	16	16
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Utilizing Exhaled Breathe Condensate Collection to Study Ion Regulation in Cystic Fibrosis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Healthy n=16 Participants Healthy Control subjects	Cystic Fibrosis n=16 Participants Patients diagnosed with cystic fibrosis	Total n=32 Participants Total of all reporting groups
Age, Continuous	25 years STANDARD_DEVIATION 6 • n=5 Participants	22 years STANDARD_DEVIATION 8 • n=7 Participants	24 years STANDARD_DEVIATION 7 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	4 Participants n=7 Participants	12 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	12 Participants n=7 Participants	20 Participants n=5 Participants
Weight (kg)	64 kg STANDARD_DEVIATION 9 • n=5 Participants	60 kg STANDARD_DEVIATION 9 • n=7 Participants	62 kg STANDARD_DEVIATION 9 • n=5 Participants
Height (cm)	169 cm STANDARD_DEVIATION 8 • n=5 Participants	166 cm STANDARD_DEVIATION 8 • n=7 Participants	167 cm STANDARD_DEVIATION 8 • n=5 Participants
BMI (kg/m2)	23 kg/m2 STANDARD_DEVIATION 3 • n=5 Participants	22 kg/m2 STANDARD_DEVIATION 3 • n=7 Participants	22 kg/m2 STANDARD_DEVIATION 3 • n=5 Participants
BSA (m2)	1.7 m2 STANDARD_DEVIATION 0.1 • n=5 Participants	1.7 m2 STANDARD_DEVIATION 0.2 • n=7 Participants	1.7 m2 STANDARD_DEVIATION 0.1 • n=5 Participants
VO2 peak (% predicted)	108 percent predicted STANDARD_DEVIATION 35 • n=5 Participants	54 percent predicted STANDARD_DEVIATION 24 • n=7 Participants	85 percent predicted STANDARD_DEVIATION 39 • n=5 Participants

PRIMARY outcome

Timeframe: up to 90-minutes post albuterol

We collected exhaled breath condensate (EBC) samples, with subjects breathing on a Jaeger EcoScreen for 20 minutes. EBC samples were collected in cystic fibrosis and healthy subjects before and 30-, 60-, and 90-minutes following albuterol administration.

Outcome measures

Outcome measures
Measure	Healthy n=16 Participants Healthy control subjects	Cystic Fibrosis n=16 Participants Patients diagnosed with cystic fibrosis
Exhaled Sodium (mmol/L) 90 minutes post	2.23 mmol/L Standard Deviation 1.34	1.86 mmol/L Standard Deviation 0.93
Exhaled Sodium (mmol/L) Baseline	2.58 mmol/L Standard Deviation 1.51	2.24 mmol/L Standard Deviation 1.09
Exhaled Sodium (mmol/L) 30 minutes post	1.97 mmol/L Standard Deviation 0.58	2.11 mmol/L Standard Deviation 0.93
Exhaled Sodium (mmol/L) 60 minutes post	2.37 mmol/L Standard Deviation 0.94	1.73 mmol/L Standard Deviation 0.85

PRIMARY outcome

Timeframe: baseline to 90 minutes post albuterol administration

The calculation of net chloride efflux was used to account for the paracellular reabsorption of Cl- that will follow the reabsorption of Na+ to maintain electroneutral ion flux. Thus, the net chloride efflux calculation used was the gross chloride concentration plus the absolute value of the percent change in sodium from baseline multiplied by the gross chloride concentration for each time point: Net Cl- efflux - \[Cl- X-min post\] + ((\[Na+ X-min post\]-\[Na+Baseline\])/ \[Na+Baseline\]) x \[Cl- X-min post\])

Outcome measures

Outcome measures
Measure	Healthy n=16 Participants Healthy control subjects	Cystic Fibrosis n=16 Participants Patients diagnosed with cystic fibrosis
Net Exhaled Chloride Baseline	0.064 mmol/L Standard Deviation 0.05	0.037 mmol/L Standard Deviation 0.02
Net Exhaled Chloride 30 minutes post	0.078 mmol/L Standard Deviation 0.143	0.048 mmol/L Standard Deviation 0.031
Net Exhaled Chloride 60 minutes post	0.084 mmol/L Standard Deviation 0.073	0.057 mmol/L Standard Deviation 0.038
Net Exhaled Chloride 90 minutes post	0.077 mmol/L Standard Deviation 0.06	0.050 mmol/L Standard Deviation 0.016

SECONDARY outcome

Timeframe: baseline, 30-, 60- and 90-minutes post albuterol administration

Using the rebreathe technique the diffusion capacity of the lungs for carbon monoxide and nitric oxide were measured, and this allowed for the determination of alveolar-capillary membrane conductance and pulmonary capillary blood volume. These measurements were made at baseline and 30-, 60- and 90-minutes post albuterol administration in cystic fibrosis and healthy subjects.

Outcome measures

Outcome measures
Measure	Healthy n=16 Participants Healthy control subjects	Cystic Fibrosis n=16 Participants Patients diagnosed with cystic fibrosis
Diffusion Capacity of the Lungs for Carbon Monoxide Baseline	21.5 mL/min/mmHg Standard Deviation 5.8	17.3 mL/min/mmHg Standard Deviation 4.4
Diffusion Capacity of the Lungs for Carbon Monoxide 30 minutes post	21.6 mL/min/mmHg Standard Deviation 5.3	17.4 mL/min/mmHg Standard Deviation 4.3
Diffusion Capacity of the Lungs for Carbon Monoxide 60 minutes post	21.6 mL/min/mmHg Standard Deviation 6.2	17.0 mL/min/mmHg Standard Deviation 4.4
Diffusion Capacity of the Lungs for Carbon Monoxide 90 minutes post	21.2 mL/min/mmHg Standard Deviation 5.5	17.1 mL/min/mmHg Standard Deviation 4.9

SECONDARY outcome

Timeframe: baseline, 30-, 60- and 90-minutes post albuterol administration

Using the rebreathe technique the diffusion capacity of the lungs for carbon monoxide and nitric oxide were measured, and this allowed for the determination of alveolar-capillary membrane conductance and pulmonary capillary blood volume. These measurements were made at baseline and 30-, 60- and 90-minutes post albuterol administration in cystic fibrosis and healthy subjects.

Outcome measures

Outcome measures
Measure	Healthy n=16 Participants Healthy control subjects	Cystic Fibrosis n=16 Participants Patients diagnosed with cystic fibrosis
Diffusion Capacity of the Lungs for Nitric Oxide Baseline	70.3 mL/min/mmHg Standard Deviation 18.9	55.0 mL/min/mmHg Standard Deviation 15.0
Diffusion Capacity of the Lungs for Nitric Oxide 30 minutes post	70.8 mL/min/mmHg Standard Deviation 16.7	56.4 mL/min/mmHg Standard Deviation 15.0
Diffusion Capacity of the Lungs for Nitric Oxide 60 minutes post	72.1 mL/min/mmHg Standard Deviation 19.2	56.2 mL/min/mmHg Standard Deviation 16.6
Diffusion Capacity of the Lungs for Nitric Oxide 90 minutes post	73.0 mL/min/mmHg Standard Deviation 20.6	58.5 mL/min/mmHg Standard Deviation 17.8

SECONDARY outcome

Timeframe: baseline, 30-, 60- and 90-minutes post albuterol

A finger pulse oximeter allowed for the measurement of peripheral oxygen saturation at baseline, 30-, 60- and 90-minutes post albuterol in cystic fibrosis and healthy subjects.

Outcome measures

Outcome measures
Measure	Healthy n=16 Participants Healthy control subjects	Cystic Fibrosis n=16 Participants Patients diagnosed with cystic fibrosis
Peripheral Oxygen Saturation Baseline	99 percent of oxygenated hemoglobin Standard Deviation 1	98 percent of oxygenated hemoglobin Standard Deviation 1
Peripheral Oxygen Saturation 30 minutes post	100 percent of oxygenated hemoglobin Standard Deviation 0	98 percent of oxygenated hemoglobin Standard Deviation 1
Peripheral Oxygen Saturation 60 minutes post	99 percent of oxygenated hemoglobin Standard Deviation 1	98 percent of oxygenated hemoglobin Standard Deviation 1
Peripheral Oxygen Saturation 90 minutes post	99 percent of oxygenated hemoglobin Standard Deviation 1	99 percent of oxygenated hemoglobin Standard Deviation 1

Adverse Events

Healthy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Cystic Fibrosis

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

Courtney Wheatley

University of Arizona

Phone: 507-266-2696

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place