Inhaled Bicarbonate Therapy in Cystic Fibrosis

Cystic Fibrosis Clinical Trial

Official title:

Inhaled Bicarbonate Therapy in Cystic Fibrosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00177645
• Other study ID #: 0405245
• Status: Completed
• Phase: Phase 1
• Start date: March 2002
• Est. completion date: December 2006

Study information

• Verified date: January 2016
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: December 2006
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

Procedure:
• sodium bicarbonate
inhalation of sodium bicarbonate or sodium chloride

Locations

Country	Name	City	State
United States	Children's Hospital of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	Cystic Fibrosis Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine the acute effects of increasing doses of inhaled bicarbonate on mucociliary clearance after a single inhalation		single dose escalation
Secondary	comparison of pre- and post-bicarbonate exhaled breath condensate pH values at a single inhalation		two doses in single day
Secondary	Safety as determined by pre- and post-clearance assay pulmonary function tests (FEV1) at a single visit		two doses in single day