Inhaled Bicarbonate Therapy in Cystic Fibrosis

This study has been completed.
Sponsor:
Collaborators:
Cystic Fibrosis Foundation
Children's Hospital of Pittsburgh
Information provided by (Responsible Party):
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00177645
First received: September 13, 2005
Last updated: August 30, 2011
Last verified: August 2011

September 13, 2005
August 30, 2011
March 2002
December 2006   (final data collection date for primary outcome measure)
  • Study 1A: Determine the acute effects of increasing doses of inhaled bicarbonate on mucociliary clearance.
  • Study 1B: Determine the acute effects of inhaled bicarbonate on mucociliary clearance.
Same as current
Complete list of historical versions of study NCT00177645 on ClinicalTrials.gov Archive Site
  • comparison of pre- and post-bicarbonate exhaled breath condensate pH values.
  • Safety as determined by pre- and post-clearance assay pulmonary function tests (FEV1)
Same as current
Not Provided
Not Provided
 
Inhaled Bicarbonate Therapy in Cystic Fibrosis
Inhaled Bicarbonate Therapy in Cystic Fibrosis

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.

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.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Cystic Fibrosis
Procedure: inhaled sodium bicarbonate
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
35
December 2006
December 2006   (final data collection date for primary outcome measure)

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
Both
12 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00177645
0405245
Not Provided
University of Pittsburgh
University of Pittsburgh
  • Cystic Fibrosis Foundation
  • Children's Hospital of Pittsburgh
Principal Investigator: Joseph M Pilewski, MD University of Pittsburgh
University of Pittsburgh
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP