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

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ClinicalTrials.gov Identifier: NCT01880723
Recruitment Status : Completed
First Posted : June 19, 2013
Results First Posted : June 25, 2014
Last Update Posted : June 25, 2014
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Courtney Wheatley, University of Arizona

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Conditions Cystic Fibrosis
Healthy
Interventions Drug: Albuterol
Drug: Placebo saline
Enrollment 32
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Healthy Cystic Fibrosis
Hide Arm/Group Description Healthy control subjects Patients diagnosed with cystic fibrosis
Period Title: Overall Study
Started 16 16
Completed 16 16
Not Completed 0 0
Arm/Group Title Healthy Cystic Fibrosis Total
Hide Arm/Group Description Healthy Control subjects Patients diagnosed with cystic fibrosis Total of all reporting groups
Overall Number of Baseline Participants 16 16 32
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 16 participants 16 participants 32 participants
25  (6) 22  (8) 24  (7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 16 participants 32 participants
Female
8
  50.0%
4
  25.0%
12
  37.5%
Male
8
  50.0%
12
  75.0%
20
  62.5%
Weight (kg)  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 16 participants 16 participants 32 participants
64  (9) 60  (9) 62  (9)
Height (cm)  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 16 participants 16 participants 32 participants
169  (8) 166  (8) 167  (8)
BMI (kg/m2)  
Mean (Standard Deviation)
Unit of measure:  Kg/m2
Number Analyzed 16 participants 16 participants 32 participants
23  (3) 22  (3) 22  (3)
BSA (m2)  
Mean (Standard Deviation)
Unit of measure:  M2
Number Analyzed 16 participants 16 participants 32 participants
1.7  (0.1) 1.7  (0.2) 1.7  (0.1)
VO2 peak (% predicted)  
Mean (Standard Deviation)
Unit of measure:  Percent predicted
Number Analyzed 16 participants 16 participants 32 participants
108  (35) 54  (24) 85  (39)
1.Primary Outcome
Title Exhaled Sodium (mmol/L)
Hide Description 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.
Time Frame up to 90-minutes post albuterol
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Healthy Cystic Fibrosis
Hide Arm/Group Description:
Healthy control subjects
Patients diagnosed with cystic fibrosis
Overall Number of Participants Analyzed 16 16
Mean (Standard Deviation)
Unit of Measure: mmol/L
Baseline 2.58  (1.51) 2.24  (1.09)
30 minutes post 1.97  (0.58) 2.11  (0.93)
60 minutes post 2.37  (0.94) 1.73  (0.85)
90 minutes post 2.23  (1.34) 1.86  (0.93)
2.Primary Outcome
Title Net Exhaled Chloride
Hide Description

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])

Time Frame baseline to 90 minutes post albuterol administration
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Healthy Cystic Fibrosis
Hide Arm/Group Description:
Healthy control subjects
Patients diagnosed with cystic fibrosis
Overall Number of Participants Analyzed 16 16
Mean (Standard Deviation)
Unit of Measure: mmol/L
Baseline 0.064  (0.05) 0.037  (0.02)
30 minutes post 0.078  (0.143) 0.048  (0.031)
60 minutes post 0.084  (0.073) 0.057  (0.038)
90 minutes post 0.077  (0.06) 0.050  (0.016)
3.Secondary Outcome
Title Diffusion Capacity of the Lungs for Carbon Monoxide
Hide Description 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.
Time Frame baseline, 30-, 60- and 90-minutes post albuterol administration
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Healthy Cystic Fibrosis
Hide Arm/Group Description:
Healthy control subjects
Patients diagnosed with cystic fibrosis
Overall Number of Participants Analyzed 16 16
Mean (Standard Deviation)
Unit of Measure: mL/min/mmHg
Baseline 21.5  (5.8) 17.3  (4.4)
30 minutes post 21.6  (5.3) 17.4  (4.3)
60 minutes post 21.6  (6.2) 17.0  (4.4)
90 minutes post 21.2  (5.5) 17.1  (4.9)
4.Secondary Outcome
Title Diffusion Capacity of the Lungs for Nitric Oxide
Hide Description 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.
Time Frame baseline, 30-, 60- and 90-minutes post albuterol administration
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Healthy Cystic Fibrosis
Hide Arm/Group Description:
Healthy control subjects
Patients diagnosed with cystic fibrosis
Overall Number of Participants Analyzed 16 16
Mean (Standard Deviation)
Unit of Measure: mL/min/mmHg
Baseline 70.3  (18.9) 55.0  (15.0)
30 minutes post 70.8  (16.7) 56.4  (15.0)
60 minutes post 72.1  (19.2) 56.2  (16.6)
90 minutes post 73.0  (20.6) 58.5  (17.8)
5.Secondary Outcome
Title Peripheral Oxygen Saturation
Hide Description 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.
Time Frame baseline, 30-, 60- and 90-minutes post albuterol
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Healthy Cystic Fibrosis
Hide Arm/Group Description:
Healthy control subjects
Patients diagnosed with cystic fibrosis
Overall Number of Participants Analyzed 16 16
Mean (Standard Deviation)
Unit of Measure: percent of oxygenated hemoglobin
Baseline 99  (1) 98  (1)
30 minutes post 100  (0) 98  (1)
60 minutes post 99  (1) 98  (1)
90 minutes post 99  (1) 99  (1)
Time Frame Within the study visit (~2 hours)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Healthy Cystic Fibrosis
Hide Arm/Group Description Healthy control subjects Patients diagnosed with cystic fibrosis
All-Cause Mortality
Healthy Cystic Fibrosis
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Healthy Cystic Fibrosis
Affected / at Risk (%) Affected / at Risk (%)
Total   0/16 (0.00%)   0/16 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Healthy Cystic Fibrosis
Affected / at Risk (%) Affected / at Risk (%)
Total   0/16 (0.00%)   0/16 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Courtney Wheatley
Organization: University of Arizona
Phone: 507-266-2696
Responsible Party: Courtney Wheatley, University of Arizona
ClinicalTrials.gov Identifier: NCT01880723     History of Changes
Other Study ID Numbers: 08-1123-01
1R01HL108962-01 ( U.S. NIH Grant/Contract )
First Submitted: June 15, 2013
First Posted: June 19, 2013
Results First Submitted: May 21, 2014
Results First Posted: June 25, 2014
Last Update Posted: June 25, 2014