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

University of Arizona

Status: Completed

Conditions: Healthy; Cystic Fibrosis

Treatments: Drug: Placebo saline; Drug: Albuterol

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01880723

1R01HL108962-01 (U.S. NIH Grant/Contract)

08-1123-01

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: All

Ages: 15 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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32 participants in 2 patient groups, including a placebo group

Albuterol

Experimental group

Description:

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

Treatment:

Drug: Albuterol

Saline (healthy only)

Placebo Comparator group

Description:

nebulized 3 ml normal saline using a Power Neb2 nebulizer

Treatment:

Drug: Placebo saline