Clinical trial NCT01880723: 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
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: University of Arizona
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2013-06-19
Enrollment: 32
Sex: ALL
Minimum age (years): 15
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


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

Primary outcomes:
measure: Exhaled Sodium (mmol/L)
timeFrame: up to 90-minutes post albuterol
measure: Net Exhaled Chloride
timeFrame: baseline to 90 minutes post albuterol administration
Secondary outcomes:
measure: Diffusion Capacity of the Lungs for Carbon Monoxide
timeFrame: baseline, 30-, 60- and 90-minutes post albuterol administration
measure: Diffusion Capacity of the Lungs for Nitric Oxide
timeFrame: baseline, 30-, 60- and 90-minutes post albuterol administration
measure: Peripheral Oxygen Saturation
timeFrame: baseline, 30-, 60- and 90-minutes post albuterol
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Department of Pharmacy Practice and Science, University of Arizona, Tucson, Arizona
state: Arizona
Study officials:
affiliation: Department of Pediatrics- Pulmonology, Allergy and Immunology, University of Arizona, Tucson, Arizona
name: Wayne J Morgan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Pediatrics- Pulmonology, Allergy and Immunology, University of Arizona, Tucson, Arizona
name: Cori M Daines, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Pharmacy Practice and Science, University of Arizona, Tucson, Arizona
name: Eric M Snyder, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Pharmacy Practice and Science, University of Arizona, Tucson, Arizona
name: Hanna Phan, PharmD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Pharmacy Practice and Science, University of Arizona, Tucson, Arizona
name: Asad Patanwalla, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.