Status:
COMPLETED
Effects of Inhaled Bicarbonate on Airway pH in Cystic Fibrosis
Lead Sponsor:
Joseph Pilewski
Collaborating Sponsors:
Cystic Fibrosis Foundation
Conditions:
Cystic Fibrosis
Eligibility:
All Genders
12+ years
Phase:
PHASE1
Brief Summary
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...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2016
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT03391414
Start Date
August 1 2014
End Date
July 1 2016
Last Update
January 5 2018
Active Locations (2)
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1
UPMC Fallk Clinic
Pittsburgh, Pennsylvania, United States, 15213
2
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, United States, 15224