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Inhaled Bicarbonate Therapy in Cystic Fibrosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00177645
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : February 17, 2016
Cystic Fibrosis Foundation
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Cystic Fibrosis Procedure: sodium bicarbonate Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Inhaled Bicarbonate Therapy in Cystic Fibrosis
Study Start Date : March 2002
Actual Primary Completion Date : December 2006
Actual Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis

Arm Intervention/treatment
Experimental: sodium bicarbonate
inhaled sodium bicarbonate
Procedure: sodium bicarbonate
inhalation of sodium bicarbonate or sodium chloride

Primary Outcome Measures :
  1. 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 :
  1. comparison of pre- and post-bicarbonate exhaled breath condensate pH values at a single inhalation [ Time Frame: two doses in single day ]
  2. Safety as determined by pre- and post-clearance assay pulmonary function tests (FEV1) at a single visit [ Time Frame: two doses in single day ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00177645

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United States, Pennsylvania
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Cystic Fibrosis Foundation
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Principal Investigator: Joseph M Pilewski, MD University of Pittsburgh
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Responsible Party: University of Pittsburgh Identifier: NCT00177645    
Other Study ID Numbers: 0405245
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: February 17, 2016
Last Verified: January 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University of Pittsburgh:
cystic fibrosis
mucus clearance
Additional relevant MeSH terms:
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Cystic Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases