Back to resultsEffects of Inhaled Bicarbonate on Airway pH in Cystic Fibrosis
Primary Purpose
Cystic Fibrosis
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
hypertonic bicarbonate
sodium chloride
Sponsored by
About this trial
This is an interventional basic science trial for Cystic Fibrosis focused on measuring thick mucus, obstructive lung disease
Eligibility Criteria
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.
Sites / Locations
- UPMC Fallk Clinic
- Children's Hospital of Pittsburgh of UPMC
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
hypertonic bicarbonate
hypertonic saline
Arm Description
subjects will be administered a solution of 8.4% hypertonic bicarbonate by nebulizer
subjects will be administered a solution of 7% sodium chloride by nebulizer
Outcomes
Primary Outcome Measures
Exhaled breath condensate pH change
Change in pH after inhalation of two doses on one day
Secondary Outcome Measures
Expectorated sputum change
Change in sputum wet-to-dry ratio ratio after inhalation of two doses on one day
Spirometry
FEV1 before and after inhalation of two doses on one day
Full Information
NCT ID
NCT03391414
First Posted
June 20, 2012
Last Updated
December 28, 2017
Sponsor
Joseph Pilewski
Collaborators
Cystic Fibrosis Foundation
1. Study Identification
Unique Protocol Identification Number
NCT03391414
Brief Title
Effects of Inhaled Bicarbonate on Airway pH in Cystic Fibrosis
Official Title
Effects of Inhaled Bicarbonate on Airway pH in Cystic Fibrosis
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
August 2014 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
July 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Joseph Pilewski
Collaborators
Cystic Fibrosis Foundation
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis
Keywords
thick mucus, obstructive lung disease
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
hypertonic bicarbonate
Arm Type
Experimental
Arm Description
subjects will be administered a solution of 8.4% hypertonic bicarbonate by nebulizer
Arm Title
hypertonic saline
Arm Type
Active Comparator
Arm Description
subjects will be administered a solution of 7% sodium chloride by nebulizer
Intervention Type
Drug
Intervention Name(s)
hypertonic bicarbonate
Other Intervention Name(s)
sodium bicarbonate
Intervention Description
8.4% sodium bicarbonate inhaled
Intervention Type
Drug
Intervention Name(s)
sodium chloride
Other Intervention Name(s)
hyper-sal
Intervention Description
7% sodium chloride inhaled
Primary Outcome Measure Information:
Title
Exhaled breath condensate pH change
Description
Change in pH after inhalation of two doses on one day
Time Frame
two time points (baseline and four (4) hours)
Secondary Outcome Measure Information:
Title
Expectorated sputum change
Description
Change in sputum wet-to-dry ratio ratio after inhalation of two doses on one day
Time Frame
two time points (Baseline and four (4) hours)
Title
Spirometry
Description
FEV1 before and after inhalation of two doses on one day
Time Frame
two time points (baseline and four (4) hours)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph M PIlewski, MD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
UPMC Fallk Clinic
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Children's Hospital of Pittsburgh of UPMC
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effects of Inhaled Bicarbonate on Airway pH in Cystic Fibrosis
We'll reach out to this number within 24 hrs