Inhaled Bicarbonate Therapy in Cystic Fibrosis

Study Overview
=================
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.

Official Title
-----------------
Inhaled Bicarbonate Therapy in Cystic Fibrosis

Conditions
-----------------
Cystic Fibrosis

Intervention / Treatment
-----------------
* Procedure: sodium bicarbonate


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 12 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: sodium bicarbonate<br>inhaled sodium bicarbonate | Procedure: sodium bicarbonate<br>* inhalation of sodium bicarbonate or sodium chloride<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the acute effects of increasing doses of inhaled bicarbonate on mucociliary clearance after a single inhalation |  | single dose escalation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| comparison of pre- and post-bicarbonate exhaled breath condensate pH values at a single inhalation |  | two doses in single day | 
| Safety as determined by pre- and post-clearance assay pulmonary function tests (FEV1) at a single visit |  | two doses in single day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cystic fibrosis, mucus clearance