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Inhaled Bicarbonate Therapy in Cystic Fibrosis

This study has been completed.
Sponsor:
Collaborators:
Cystic Fibrosis Foundation Therapeutics
Children's Hospital of Pittsburgh
Information provided by (Responsible Party):
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00177645
First received: September 13, 2005
Last updated: February 12, 2016
Last verified: January 2016

September 13, 2005
February 12, 2016
March 2002
December 2006   (final data collection date for primary outcome measure)
Determine the acute effects of increasing doses of inhaled bicarbonate on mucociliary clearance after a single inhalation [ Time Frame: single dose escalation ] [ Designated as safety issue: No ]
  • 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.
Complete list of historical versions of study NCT00177645 on ClinicalTrials.gov Archive Site
  • comparison of pre- and post-bicarbonate exhaled breath condensate pH values at a single inhalation [ Time Frame: two doses in single day ] [ Designated as safety issue: No ]
  • Safety as determined by pre- and post-clearance assay pulmonary function tests (FEV1) at a single visit [ Time Frame: two doses in single day ] [ Designated as safety issue: No ]
  • comparison of pre- and post-bicarbonate exhaled breath condensate pH values.
  • Safety as determined by pre- and post-clearance assay pulmonary function tests (FEV1)
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 1
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Cystic Fibrosis
Procedure: sodium bicarbonate
inhalation of sodium bicarbonate or sodium chloride
Experimental: sodium bicarbonate
inhaled sodium bicarbonate
Intervention: Procedure: sodium bicarbonate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
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   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00177645
0405245
No
No
Not Provided
University of Pittsburgh
University of Pittsburgh
  • Cystic Fibrosis Foundation Therapeutics
  • Children's Hospital of Pittsburgh
Principal Investigator: Joseph M Pilewski, MD University of Pittsburgh
University of Pittsburgh
January 2016

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