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Cystic FibrosisNCT01880723

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

A study testing Albuterol in people with Cystic Fibrosis and Healthy, run by University of Arizona at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 15 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Cystic Fibrosis, Healthy
What is being tested?
Albuterol
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
32 participants
Where
1 siteUnited States
Study dates
May 2009to Jan 2013
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • Healthy subjects:
  • no cardiovascular abnormalities
  • not overweight BMI>25
  • 18-55 years of age
  • CF subjects:
  • mild to moderate CF (FEV1>40% predicted)
Show all 9Show fewer
  • clinically diagnosed with positive sweat test (sweat Cl->60mmol/L)
  • 10-55 years of age
  • clinically stable

Who cannot join

  • 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
Show all 20Show fewer
  • 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 locations and contacts

1 site in 1 country.

United States1 site

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

    Tucson, Arizona, 85721

Other trials in United States

About this study

Official title: Modifying Genes in Cystic Fibrosis: The Beta-2 Adrenergic Receptors and Epithelial Na+ Channels

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.

Being tested
Albuterol, Placebo saline
Keywords
exhaled breath condensate, diffusion capacity of the lungs for carbon monoxide and nitric oxide, albuterol, peripheral oxygen saturation, ion regulation
Medical subject headings
Cystic Fibrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AlbuterolDrug

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

  • Placebo salineDrug

    nebulized 3mL normal saline) using a Power Neb2 nebulizer

Study groups in NCT01880723
Study groupRoleWhat they receive
AlbuterolExperimental2.5 mg diluted in 3mL normal saline nebulized using a Power Neb2 nebulizer
Receives: Drug: Albuterol
Saline (healthy only)Placebo comparatornebulized 3 ml normal saline using a Power Neb2 nebulizer
Receives: Drug: Placebo saline

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Exhaled Sodium (mmol/L)

    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.

    Measured: up to 90-minutes post albuterol

  2. Net Exhaled Chloride

    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])

    Measured: baseline to 90 minutes post albuterol administration

Secondary outcomes (3)

  1. Diffusion Capacity of the Lungs for Carbon Monoxide

    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.

    Measured: baseline, 30-, 60- and 90-minutes post albuterol administration

  2. Diffusion Capacity of the Lungs for Nitric Oxide

    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.

    Measured: baseline, 30-, 60- and 90-minutes post albuterol administration

  3. Peripheral Oxygen Saturation

    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.

    Measured: baseline, 30-, 60- and 90-minutes post albuterol

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jun 2013 (estimated)
  2. Study startMay 2009
  3. Primary completionJul 2012
  4. Study completionJan 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01880723
Sponsor's protocol ID
08-1123-01
Other IDs
1R01HL108962-01
Status last verified
Nov 2023
First submitted
15 Jun 2013
Last updated
29 Nov 2023
Data monitoring committee
No

Publications

  • 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.

    PubMed 21889619

  • 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.

    PubMed 21893217

  • 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.

    PubMed 21050829

  • 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.

    PubMed 21703359

  • 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.

    PubMed 21923601

Questions about this trial

What is this clinical trial studying?

A study testing Albuterol in people with Cystic Fibrosis and Healthy, run by University of Arizona at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Jun 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Exhaled Sodium (mmol/L) (time frame: up to 90-minutes post albuterol). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01880723, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2023; AzTrials last refreshed its copy on 6 Nov 2026.

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