Inhaled Bicarbonate Therapy in Cystic Fibrosis
Tracking Information | |||||
---|---|---|---|---|---|
First Received Date ICMJE | September 13, 2005 | ||||
Last Updated Date | August 30, 2011 | ||||
Start Date ICMJE | March 2002 | ||||
Primary Completion Date | December 2006 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
|
||||
Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | Complete list of historical versions of study NCT00177645 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
|
||||
Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
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 | Phase 2 | ||||
Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label |
||||
Condition ICMJE | Cystic Fibrosis | ||||
Intervention ICMJE | Procedure: inhaled sodium bicarbonate | ||||
Study Arm (s) | |||||
Publications * | |||||
* 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 | ||||
Enrollment ICMJE | 35 | ||||
Completion Date | December 2006 | ||||
Primary Completion Date | December 2006 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||
Gender | Both | ||||
Ages | 12 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | United States | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT00177645 | ||||
Other Study ID Numbers ICMJE | 0405245 | ||||
Has Data Monitoring Committee | |||||
Responsible Party | University of Pittsburgh | ||||
Study Sponsor ICMJE | University of Pittsburgh | ||||
Collaborators ICMJE |
|
||||
Investigators ICMJE |
|
||||
Information Provided By | University of Pittsburgh | ||||
Verification Date | August 2011 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |