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

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Albuterol

Placebo saline

About this trial

This is an interventional basic science trial for Cystic Fibrosis focused on measuring exhaled breath condensate, diffusion capacity of the lungs for carbon monoxide and nitric oxide, albuterol, peripheral oxygen saturation, ion regulation

Eligibility Criteria

15 Years - 55 Years (Child, Adult)Accepts Healthy Volunteers

Inclusion Criteria:

Healthy subjects:

no cardiovascular abnormalities
not overweight BMI>25
18-55 years of age

CF subjects:

mild to moderate CF (FEV1>40% predicted)
clinically diagnosed with positive sweat test (sweat Cl->60mmol/L)
10-55 years of age
clinically stable

Exclusion Criteria:

Healthy subjects will be excluded if:

If unable to consent for him/herself (cognitive impairment)
Have a history or evidence of cardiovascular and/or pulmonary abnormalities.
Have an abnormal 12-lead EKG
Have an abnormal pulmonary function test
Have a history of asthma
Have a history of renal disease or estimated creatinine clearance < 55ml/min
Women who are pregnant or planning to become pregnant during the study

CF subjects:

If unable to consent for him/herself (cognitive impairment)
Physically unable to perform exercise or breathing tests
Have a history of renal disease or estimated creatinine clearance < 55ml/min
Women who are pregnant or planning to become pregnant during the study.
Have an abnormal 12-lead EKG
Cystic Fibrosis related diabetes is uncontrolled
Forced Expiratory Volume after 1 second (FEV1) is less than 40% predicted
Have a history of joint disease
Have history of pulmonary exacerbation within the last two weeks
Experienced pulmonary hemorrhage within 6 months resulting in greater than 50cc of blood in the sputum
not currently enrolled in any other research study

Sites / Locations

Department of Pharmacy Practice and Science, University of Arizona, Tucson, Arizona

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Albuterol

Saline (healthy only)

Arm Description

2.5 mg diluted in 3mL normal saline nebulized using a Power Neb2 nebulizer

nebulized 3 ml normal saline using a Power Neb2 nebulizer

Outcomes

Primary Outcome Measures

Exhaled Sodium (mmol/L)

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.

Net Exhaled Chloride

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])

Secondary Outcome Measures

Diffusion Capacity of the Lungs for Carbon Monoxide

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.

Diffusion Capacity of the Lungs for Nitric Oxide

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.

Peripheral Oxygen Saturation

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.

Full Information

NCT ID

NCT01880723

First Posted

June 15, 2013

Last Updated

May 21, 2014

Sponsor

University of Arizona

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

1. Study Identification

Unique Protocol Identification Number

NCT01880723

Brief Title

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

Official Title

Modifying Genes in Cystic Fibrosis: The Beta-2 Adrenergic Receptors and Epithelial Na+ Channels

Study Type

Interventional

2. Study Status

Record Verification Date

May 2014

Overall Recruitment Status

Completed

Study Start Date

May 2009 (undefined)

Primary Completion Date

July 2012 (Actual)

Study Completion Date

January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Arizona

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Data Monitoring Committee

No

5. Study Description

Brief Summary

Our aims were to determine if exhaled breath condensate (EBC) could detect differences in ion regulation between cystic fibrosis (CF) and healthy and measure the effect of the albuterol on EBC ions in these populations. We hypothesized EBC chloride and sodium would be lower in CF patients at baseline and that albuterol would decrease EBC sodium and increase EBC chloride.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cystic Fibrosis, Healthy

Keywords

exhaled breath condensate, diffusion capacity of the lungs for carbon monoxide and nitric oxide, albuterol, peripheral oxygen saturation, ion regulation

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

32 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Albuterol

Arm Type

Experimental

Arm Description

2.5 mg diluted in 3mL normal saline nebulized using a Power Neb2 nebulizer

Arm Title

Saline (healthy only)

Arm Type

Placebo Comparator

Arm Description

nebulized 3 ml normal saline using a Power Neb2 nebulizer

Intervention Type

Drug

Intervention Name(s)

Albuterol

Intervention Description

2.5 mg diluted in 3mL normal saline nebulized using a Power Neb2 nebulizer

Intervention Type

Drug

Intervention Name(s)

Placebo saline

Intervention Description

nebulized 3mL normal saline) using a Power Neb2 nebulizer

Primary Outcome Measure Information:

Title

Exhaled Sodium (mmol/L)

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

Title

Net Exhaled Chloride

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

Secondary Outcome Measure Information:

Title

Diffusion Capacity of the Lungs for Carbon Monoxide

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

Title

Diffusion Capacity of the Lungs for Nitric Oxide

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

Title

Peripheral Oxygen Saturation

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

10. Eligibility

Minimum Age & Unit of Time

15 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Healthy subjects: no cardiovascular abnormalities not overweight BMI>25 18-55 years of age CF subjects: mild to moderate CF (FEV1>40% predicted) clinically diagnosed with positive sweat test (sweat Cl->60mmol/L) 10-55 years of age clinically stable Exclusion Criteria: Healthy subjects will be excluded if: If unable to consent for him/herself (cognitive impairment) Have a history or evidence of cardiovascular and/or pulmonary abnormalities. Have an abnormal 12-lead EKG Have an abnormal pulmonary function test Have a history of asthma Have a history of renal disease or estimated creatinine clearance < 55ml/min Women who are pregnant or planning to become pregnant during the study CF subjects: If unable to consent for him/herself (cognitive impairment) Physically unable to perform exercise or breathing tests Have a history of renal disease or estimated creatinine clearance < 55ml/min Women who are pregnant or planning to become pregnant during the study. Have an abnormal 12-lead EKG Cystic Fibrosis related diabetes is uncontrolled Forced Expiratory Volume after 1 second (FEV1) is less than 40% predicted Have a history of joint disease Have history of pulmonary exacerbation within the last two weeks Experienced pulmonary hemorrhage within 6 months resulting in greater than 50cc of blood in the sputum not currently enrolled in any other research study

Overall Study Officials: