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Effects of Inhaled Bicarbonate on Airway pH in Cystic Fibrosis

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ClinicalTrials.gov Identifier: NCT03391414
Recruitment Status : Completed
First Posted : January 5, 2018
Last Update Posted : January 5, 2018
Sponsor:
Collaborator:
Cystic Fibrosis Foundation
Information provided by (Responsible Party):
Joseph Pilewski, University of Pittsburgh

Study Description
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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.

Condition or disease Intervention/treatment Phase
Cystic Fibrosis Drug: hypertonic bicarbonate Drug: sodium chloride Phase 1

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Effects of Inhaled Bicarbonate on Airway pH in Cystic Fibrosis
Study Start Date : August 2014
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis

Arms and Interventions
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Arm Intervention/treatment
Experimental: hypertonic bicarbonate
subjects will be administered a solution of 8.4% hypertonic bicarbonate by nebulizer
 Drug: hypertonic bicarbonate
8.4% sodium bicarbonate inhaled
Other Name: sodium bicarbonate
Active Comparator: hypertonic saline
subjects will be administered a solution of 7% sodium chloride by nebulizer
 Drug: sodium chloride
7% sodium chloride inhaled
Other Name: hyper-sal


Outcome Measures
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Primary Outcome Measures :
  1. Exhaled breath condensate pH change [ Time Frame: two time points (baseline and four (4) hours) ]
    Change in pH after inhalation of two doses on one day


Secondary Outcome Measures :
  1. Expectorated sputum change [ Time Frame: two time points (Baseline and four (4) hours) ]
    Change in sputum wet-to-dry ratio ratio after inhalation of two doses on one day

  2. Spirometry [ Time Frame: two time points (baseline and four (4) hours) ]
    FEV1 before and after inhalation of two doses on one day


Eligibility Criteria
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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03391414


Locations
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United States, Pennsylvania
UPMC Fallk Clinic
Pittsburgh, Pennsylvania, United States, 15213
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, United States, 15224
Sponsors and Collaborators
Joseph Pilewski
Cystic Fibrosis Foundation
Investigators
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Principal Investigator: Joseph M PIlewski, MD University of Pittsburgh
More Information
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Responsible Party: Joseph Pilewski, Associate Professor of Medicine and Pediatrics, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT03391414    
Other Study ID Numbers: PRO09120363
First Posted: January 5, 2018    Key Record Dates
Last Update Posted: January 5, 2018
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Joseph Pilewski, University of Pittsburgh:
thick mucus
obstructive lung disease
Additional relevant MeSH terms:
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Cystic Fibrosis
Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
 Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases