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

NCT01880723 | Completed Results

• 2 other identifiers: 08-1123-011R01HL108962-01
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Cystic Fibrosis; Healthy

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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.

  up to 90-minutes post albuterol

• 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 \[Cl- X-min post\])

  baseline to 90 minutes post albuterol administration

Secondary Outcomes (3)

• Diffusion Capacity of the Lungs for Carbon Monoxide

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

• Diffusion Capacity of the Lungs for Nitric Oxide

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

• Peripheral Oxygen Saturation

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

Study Arms (2)

Albuterol

EXPERIMENTAL

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

Drug: Albuterol

Saline (healthy only)

PLACEBO COMPARATOR

nebulized 3 ml normal saline using a Power Neb2 nebulizer

Drug: Placebo saline

Interventions

Albuterol DRUG

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

Albuterol

Placebo saline DRUG

nebulized 3mL normal saline) using a Power Neb2 nebulizer

Saline (healthy only)

Eligibility Criteria

• Age: 15 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Healthy subjects:
• no cardiovascular abnormalities
• not overweight BMI\>25
• years of age
• CF subjects:
• mild to moderate CF (FEV1\>40% predicted)
• clinically diagnosed with positive sweat test (sweat Cl-\>60mmol/L)
• years of age
• clinically stable

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Arizona: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

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

Tucson, Arizona, 85721, United States

Location

Related Publications (5)

• Foxx-Lupo WT, Wheatley CM, Baker SE, Cassuto NA, Delamere NA, Snyder EM. Genetic variation of the alpha subunit of the epithelial Na+ channel influences exhaled Na+ in healthy humans. Respir Physiol Neurobiol. 2011 Dec 15;179(2-3):205-11. doi: 10.1016/j.resp.2011.08.008. Epub 2011 Aug 26.

  PMID: 21889619 RESULT

• Baker SE, Wheatley CM, Cassuto NA, Foxx-Lupo WT, Sprissler R, Snyder EM. Genetic variation of alphaENaC influences lung diffusion during exercise in humans. Respir Physiol Neurobiol. 2011 Dec 15;179(2-3):212-8. doi: 10.1016/j.resp.2011.08.007. Epub 2011 Aug 26.

  PMID: 21893217 RESULT

• Wheatley CM, Foxx-Lupo WT, Cassuto NA, Wong EC, Daines CL, Morgan WJ, Snyder EM. Impaired lung diffusing capacity for nitric oxide and alveolar-capillary membrane conductance results in oxygen desaturation during exercise in patients with cystic fibrosis. J Cyst Fibros. 2011 Jan;10(1):45-53. doi: 10.1016/j.jcf.2010.09.006. Epub 2010 Nov 2.

  PMID: 21050829 RESULT

• Traylor BR, Wheatley CM, Skrentny TT Jr, Foxx-Lupo WT, Phan H, Patanwala AE, Morgan WJ, Daines CL, Sprissler R, Snyder EM. Influence of genetic variation of the beta2-adrenergic receptor on lung diffusion in patients with cystic fibrosis. Pulm Pharmacol Ther. 2011 Oct;24(5):610-6. doi: 10.1016/j.pupt.2011.06.001. Epub 2011 Jun 15.

  PMID: 21703359 RESULT

• Snyder EM, Wong EC, Foxx-Lupo WT, Wheatley CM, Cassuto NA, Patanwala AE. Effects of an inhaled beta2-agonist on cardiovascular function and sympathetic activity in healthy subjects. Pharmacotherapy. 2011 Aug;31(8):748-56. doi: 10.1592/phco.31.8.748.

  PMID: 21923601 RESULT

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

Albuterol

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines

Results Point of Contact

• Title: Courtney Wheatley
• Organization: University of Arizona

wheatley.courtney@mayo.edu

507-266-2696

Study Officials

• Wayne J Morgan, MD

  Department of Pediatrics- Pulmonology, Allergy and Immunology, University of Arizona, Tucson, Arizona

  PRINCIPAL INVESTIGATOR

• Cori M Daines, MD

  Department of Pediatrics- Pulmonology, Allergy and Immunology, University of Arizona, Tucson, Arizona

  PRINCIPAL INVESTIGATOR

• Eric M Snyder, PhD

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

  PRINCIPAL INVESTIGATOR

• Hanna Phan, PharmD

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

  PRINCIPAL INVESTIGATOR

• Asad Patanwalla, PharmD

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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Graduate Research Assistant

Study Record Dates

• First Submitted: June 15, 2013
• First Posted: June 19, 2013
• Study Start: May 1, 2009
• Primary Completion: July 1, 2012
• Study Completion: January 1, 2013
• Last Updated: November 29, 2023
• Results First Posted: June 25, 2014

Record last verified: 2023-11

Locations

US (1)