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Inhaled Bicarbonate Therapy in Cystic Fibrosis

This study has been completed.
Cystic Fibrosis Foundation Therapeutics
Children's Hospital of Pittsburgh
Information provided by (Responsible Party):
University of Pittsburgh Identifier:
First received: September 13, 2005
Last updated: February 12, 2016
Last verified: January 2016
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.

Condition Intervention Phase
Cystic Fibrosis
Procedure: sodium bicarbonate
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Inhaled Bicarbonate Therapy in Cystic Fibrosis

Resource links provided by NLM:

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Determine the acute effects of increasing doses of inhaled bicarbonate on mucociliary clearance after a single inhalation [ Time Frame: single dose escalation ]

Secondary Outcome Measures:
  • comparison of pre- and post-bicarbonate exhaled breath condensate pH values at a single inhalation [ Time Frame: two doses in single day ]
  • Safety as determined by pre- and post-clearance assay pulmonary function tests (FEV1) at a single visit [ Time Frame: two doses in single day ]

Enrollment: 16
Study Start Date: March 2002
Study Completion Date: December 2006
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: sodium bicarbonate
inhaled sodium bicarbonate
Procedure: sodium bicarbonate
inhalation of sodium bicarbonate or sodium chloride

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.


Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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
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Please refer to this study by its identifier: NCT00177645

United States, Pennsylvania
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Cystic Fibrosis Foundation Therapeutics
Children's Hospital of Pittsburgh
Principal Investigator: Joseph M Pilewski, MD University of Pittsburgh
  More Information

Responsible Party: University of Pittsburgh Identifier: NCT00177645     History of Changes
Other Study ID Numbers: 0405245
Study First Received: September 13, 2005
Last Updated: February 12, 2016
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by University of Pittsburgh:
cystic fibrosis
mucus clearance

Additional relevant MeSH terms:
Cystic Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases processed this record on April 26, 2017