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

NCT ID: NCT01880723

Last Updated: 2023-11-29

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2013-01-31

Brief Summary

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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

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Conditions

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Cystic Fibrosis Healthy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Albuterol

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

Group Type EXPERIMENTAL

Albuterol

Intervention Type DRUG

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

Saline (healthy only)

nebulized 3 ml normal saline using a Power Neb2 nebulizer

Group Type PLACEBO_COMPARATOR

Placebo saline

Intervention Type DRUG

nebulized 3mL normal saline) using a Power Neb2 nebulizer

Interventions

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Albuterol

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

Intervention Type DRUG

Placebo saline

nebulized 3mL normal saline) using a Power Neb2 nebulizer

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

15 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

University of Arizona

OTHER

Sponsor Role lead

Responsible Party

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Courtney Wheatley

Graduate Research Assistant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Wayne J Morgan, MD

Role: PRINCIPAL_INVESTIGATOR

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

Cori M Daines, MD

Role: PRINCIPAL_INVESTIGATOR

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

Eric M Snyder, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Hanna Phan, PharmD

Role: PRINCIPAL_INVESTIGATOR

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

Asad Patanwalla, PharmD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Tucson, Arizona, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 21889619 (View on PubMed)

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.

Reference Type RESULT
PMID: 21893217 (View on PubMed)

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.

Reference Type RESULT
PMID: 21050829 (View on PubMed)

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.

Reference Type RESULT
PMID: 21703359 (View on PubMed)

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.

Reference Type RESULT
PMID: 21923601 (View on PubMed)

Other Identifiers

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1R01HL108962-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

08-1123-01

Identifier Type: -

Identifier Source: org_study_id