Effects of Inhaled Bicarbonate on Airway pH in Cystic Fibrosis

Study Overview
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Brief Summary
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This study will compare the use of inhaled concentrated sodium chloride solution to an inhaled solution of sodium bicarbonate in an attempt to decrease the thickness and stickiness of the mucus in the lungs of a person with cystic fibrosis. Also, this study is also looking at whether or not it is possible to decrease the acidity of the airways by inhaling sodium bicarbonate through nebulizer treatments.

Detailed Description
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This study will compare the use of inhaled concentrated sodium chloride solution to an inhaled solution of sodium bicarbonate in an attempt to decrease the thickness and stickiness of the mucus in the lungs of a person with cystic fibrosis. Also, this study is also looking at whether or not it is possible to decrease the acidity of the airways by inhaling sodium bicarbonate through nebulizer treatments.

Official Title
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Effects of Inhaled Bicarbonate on Airway pH in Cystic Fibrosis

Conditions
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Cystic Fibrosis

Intervention / Treatment
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* Drug: hypertonic bicarbonate
* Drug: sodium chloride


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: FEV1 greater than 50% predicted. Ability to spontaneously expectorate sputum (with or without chest physiotherapy). Stable disease as defined by absence of exclusion criteria numbers 3-5 and clinician assessment. Exclusion Criteria: Reactive airway disease Use of inhaled hypertonic saline in the past 28 days Use of IV antibiotics in the past 4 weeks Changes in CF-related medications in the four weeks prior to study screening SpO2 < 94% on room air or use of supplemental oxygen. Presence of untreated gastroesophageal reflux disease (GERD) or residual acid reflux symptoms in cases of treated GERD more than three times per week. Pregnant or nursing females.

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: hypertonic bicarbonate<br>subjects will be administered a solution of 8.4% hypertonic bicarbonate by nebulizer | Drug: hypertonic bicarbonate<br>* 8.4% sodium bicarbonate inhaled<br>* Other names: sodium bicarbonate;|
| Active Comparator: hypertonic saline<br>subjects will be administered a solution of 7% sodium chloride by nebulizer | Drug: sodium chloride<br>* 7% sodium chloride inhaled<br>* Other names: hyper-sal;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exhaled breath condensate pH change | Change in pH after inhalation of two doses on one day | two time points (baseline and four (4) hours) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Expectorated sputum change | Change in sputum wet-to-dry ratio ratio after inhalation of two doses on one day | two time points (Baseline and four (4) hours) | 
| Spirometry | FEV1 before and after inhalation of two doses on one day | two time points (baseline and four (4) hours) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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thick mucus, obstructive lung disease