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Inhaled Bicarbonate Therapy in Cystic Fibrosis

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ClinicalTrials.gov Identifier: NCT00177645
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : February 17, 2016
Sponsor:
Collaborator:
Cystic Fibrosis Foundation
Information provided by (Responsible Party):
University of Pittsburgh

Tracking Information
First Submitted Date  ICMJE September 13, 2005
First Posted Date  ICMJE September 15, 2005
Last Update Posted Date February 17, 2016
Study Start Date  ICMJE March 2002
Actual Primary Completion Date December 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 12, 2016)
Determine the acute effects of increasing doses of inhaled bicarbonate on mucociliary clearance after a single inhalation [ Time Frame: single dose escalation ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 13, 2005)
  • 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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 12, 2016)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 13, 2005)
  • comparison of pre- and post-bicarbonate exhaled breath condensate pH values.
  • Safety as determined by pre- and post-clearance assay pulmonary function tests (FEV1)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Inhaled Bicarbonate Therapy in Cystic Fibrosis
Official Title  ICMJE Inhaled Bicarbonate Therapy in Cystic Fibrosis
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Cystic Fibrosis
Intervention  ICMJE Procedure: sodium bicarbonate
inhalation of sodium bicarbonate or sodium chloride
Study Arms  ICMJE Experimental: sodium bicarbonate
inhaled sodium bicarbonate
Intervention: Procedure: sodium bicarbonate
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 12, 2016)
16
Original Enrollment  ICMJE
 (submitted: September 13, 2005)
35
Actual Study Completion Date  ICMJE December 2006
Actual Primary Completion Date December 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00177645
Other Study ID Numbers  ICMJE 0405245
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of Pittsburgh
Study Sponsor  ICMJE University of Pittsburgh
Collaborators  ICMJE Cystic Fibrosis Foundation
Investigators  ICMJE
Principal Investigator: Joseph M Pilewski, MD University of Pittsburgh
PRS Account University of Pittsburgh
Verification Date January 2016

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