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Completed

NCT Number: NCT01880723

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

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.

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Key information

Conditions

Cystic Fibrosis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Genetic Diseases, Inborn Healthy Infant, Newborn, Diseases Lung Diseases Pancreatic Diseases Respiratory Tract Diseases

Age range

15 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Tucson, Arizona, 85721, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

albuterol

Drug

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

Placebo saline

Drug

nebulized 3mL normal saline) using a Power Neb2 nebulizer

Primary outcomes

  1. Exhaled Sodium (mmol/L)

    Time frame: 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.

  2. Net Exhaled Chloride

    Time frame: 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])

Secondary outcomes

  1. Diffusion Capacity of the Lungs for Carbon Monoxide

    Time frame: 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.

  2. Diffusion Capacity of the Lungs for Nitric Oxide

    Time frame: 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.

  3. Peripheral Oxygen Saturation

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Arizona

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2012
Study completion
2013
First posted
Jun 19, 2013
Registry last updated
Nov 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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