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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

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.

Condition or disease Intervention/treatment Phase
Cystic Fibrosis Healthy Drug: Albuterol Drug: Placebo saline Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Modifying Genes in Cystic Fibrosis: The Beta-2 Adrenergic Receptors and Epithelial Na+ Channels
Study Start Date : May 2009
Actual Primary Completion Date : July 2012
Actual Study Completion Date : January 2013


Arm Intervention/treatment
Experimental: Albuterol
2.5 mg diluted in 3mL normal saline nebulized using a Power Neb2 nebulizer
Drug: Albuterol
2.5 mg diluted in 3mL normal saline nebulized using a Power Neb2 nebulizer

Placebo Comparator: Saline (healthy only)
nebulized 3 ml normal saline using a Power Neb2 nebulizer
Drug: Placebo saline
nebulized 3mL normal saline) using a Power Neb2 nebulizer




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   15 Years to 55 Years   (Child, Adult)
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01880723


Locations
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United States, Arizona
Department of Pharmacy Practice and Science, University of Arizona, Tucson, Arizona
Tucson, Arizona, United States, 85721
Sponsors and Collaborators
University of Arizona
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: 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

Publications of Results:
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Responsible Party: Courtney Wheatley, Graduate Research Assistant, 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 Posted: June 19, 2013    Key Record Dates
Results First Posted: June 25, 2014
Last Update Posted: June 25, 2014
Last Verified: May 2014
Keywords provided by Courtney Wheatley, University of Arizona:
exhaled breath condensate
diffusion capacity of the lungs for carbon monoxide and nitric oxide
albuterol
peripheral oxygen saturation
ion regulation
Additional relevant MeSH terms:
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Cystic Fibrosis
Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Albuterol
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Tocolytic Agents
Reproductive Control Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action