Inhaled Bicarbonate Therapy in Cystic Fibrosis

Phase 1

Completed

• Conditions: Cystic Fibrosis
• Interventions: Procedure: sodium bicarbonate

• Registration Number: NCT00177645
• Lead Sponsor: University of Pittsburgh

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.

Study Timeline

• Study Start: 2002-03
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-15
• Primary Completion: 2006-12
• Study Completion: 2006-12
• Status Verified: 2016-01
• Last Update Submitted: 2023-09-06
• Last Update Posted: 2023-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
sodium bicarbonate	sodium bicarbonate	inhaled sodium bicarbonate

Primary Outcome Measures

Name	Time	Method
Determine the acute effects of increasing doses of inhaled bicarbonate on mucociliary clearance after a single inhalation	single dose escalation

Secondary Outcome Measures

Name	Time	Method
Safety as determined by pre- and post-clearance assay pulmonary function tests (FEV1) at a single visit	two doses in single day
comparison of pre- and post-bicarbonate exhaled breath condensate pH values at a single inhalation	two doses in single day

Trial Locations

Locations (1)

Children's Hospital of Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States