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

Not Applicable
Completed
Conditions
Cystic Fibrosis
Healthy
Interventions
Drug: Placebo saline
Registration Number
NCT01880723
Lead Sponsor
University of Arizona
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
32
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
AlbuterolAlbuterol2.5 mg diluted in 3mL normal saline nebulized using a Power Neb2 nebulizer
Saline (healthy only)Placebo salinenebulized 3 ml normal saline using a Power Neb2 nebulizer
Primary Outcome Measures
NameTimeMethod
Exhaled Sodium (mmol/L)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.

Net Exhaled Chloridebaseline 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 \[Cl- X-min post\])

Secondary Outcome Measures
NameTimeMethod
Diffusion Capacity of the Lungs for Carbon Monoxidebaseline, 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.

Diffusion Capacity of the Lungs for Nitric Oxidebaseline, 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.

Peripheral Oxygen Saturationbaseline, 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.

Trial Locations

Locations (1)

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

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Tucson, Arizona, United States

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