Effects of Inhaled Bicarbonate on Airway pH in Cystic Fibrosis



Status:Completed
Conditions:Pulmonary
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:12 - Any
Updated:1/7/2018
Start Date:August 2014
End Date:July 2016

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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.

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.

Inclusion Criteria:

1. FEV1 greater than 50% predicted.

2. Ability to spontaneously expectorate sputum (with or without chest physiotherapy).

3. Stable disease as defined by absence of exclusion criteria numbers 3-5 and clinician
assessment.

Exclusion Criteria:

1. Reactive airway disease

2. Use of inhaled hypertonic saline in the past 28 days

3. Use of IV antibiotics in the past 4 weeks

4. Changes in CF-related medications in the four weeks prior to study screening

5. SpO2 < 94% on room air or use of supplemental oxygen.

6. Presence of untreated gastroesophageal reflux disease (GERD) or residual acid reflux
symptoms in cases of treated GERD more than three times per week.

7. Pregnant or nursing females.
We found this trial at
2
sites
4401 Penn Avenue
Pittsburgh, Pennsylvania 15224
412-692-5325
Children's Hospital of Pittsburgh of UPMC UPMC is one of the leading nonprofit health systems...
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Pittsburgh, Pennsylvania 15213
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