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Inhaled Bicarbonate Therapy in Cystic Fibrosis

Inhaled Bicarbonate Therapy in Cystic Fibrosis

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00177645
Enrollment
16
Registered
2005-09-15
Start date
2002-03-31
Completion date
2006-12-31
Last updated
2023-09-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cystic Fibrosis

Keywords

cystic fibrosis, mucus clearance

Brief summary

The purpose of this study is to see if inhaled bicarbonate will increase the ability to cough up mucus in a person with cystic fibrosis.

Detailed description

There is evidence that people with CF may have differences in the liquid that lines the surface of their lungs from people without CF. There are two things that are known to be different. One is called bicarbonate secretion, which is the movement of a salt called bicarbonate that is normally present in the blood and lung fluid in all people. The abnormal movement of bicarbonate appears to cause a second abnormality - the liquid in the breathing tubes has more acid than the liquid in patients without CF. These differences may affect the stickiness and thickness of the mucus and limit how well the hairs that line the breathing tubes (cilia) move mucus out of the lungs. Recent studies in a group of patients with chronic cough looked at the effects of giving an inhaled bicarbonate solution (sodium bicarbonate instead of sodium chloride) on the study subjects' ability to cough up mucus. Compared to the group given inhaled saline, the patients given inhaled bicarbonate were able to cough up approximately three times as much mucus. No clinical studies have looked at whether inhaled bicarbonate improves the ability of the lung in a person with CF to move mucus out of the lung or how this treatment affects lung function in patients with CF.

Interventions

PROCEDUREsodium bicarbonate

inhalation of sodium bicarbonate or sodium chloride

Sponsors

Cystic Fibrosis Foundation
CollaboratorOTHER
University of Pittsburgh
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* age 12 or older * Forced expiratory volume in one second (FEV1) \>40% predicted * Ability to expectorate sputum

Exclusion criteria

* pregnancy * pulmonary exacerbation or initiation of inhaled or oral antibiotics, steroids, or aerosol treatments within the last four weeks * oxygen saturation \<92%, or requirement for supplemental oxygen

Design outcomes

Primary

MeasureTime frame
Determine the acute effects of increasing doses of inhaled bicarbonate on mucociliary clearance after a single inhalationsingle dose escalation

Secondary

MeasureTime frame
comparison of pre- and post-bicarbonate exhaled breath condensate pH values at a single inhalationtwo doses in single day
Safety as determined by pre- and post-clearance assay pulmonary function tests (FEV1) at a single visittwo doses in single day

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026