Status:
COMPLETED
Utilizing Exhaled Breathe Condensate Collection to Study Ion Regulation in Cystic Fibrosis
Lead Sponsor:
University of Arizona
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Cystic Fibrosis
Healthy
Eligibility:
All Genders
15-55 years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2013
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT01880723
Start Date
May 1 2009
End Date
January 1 2013
Last Update
November 29 2023
Active Locations (1)
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1
Department of Pharmacy Practice and Science, University of Arizona, Tucson, Arizona
Tucson, Arizona, United States, 85721