Effects of Inhaled Bicarbonate on Airway pH in Cystic Fibrosis

December 28, 2017 updated by: Joseph Pilewski
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 Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15224
        • Children's Hospital of Pittsburgh of UPMC
      • Pittsburgh, Pennsylvania, United States, 15213
        • UPMC Fallk Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • hyper-sal

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
two time points (baseline and four (4) hours)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
two time points (Baseline and four (4) hours)
Spirometry
Time Frame: two time points (baseline and four (4) hours)
FEV1 before and after inhalation of two doses on one day
two time points (baseline and four (4) hours)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Joseph Pilewski

Collaborators

Cystic Fibrosis Foundation

Investigators

  • Principal Investigator: Joseph M Pilewski, MD, University of Pittsburgh

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

June 20, 2012

First Submitted That Met QC Criteria

December 28, 2017

First Posted (Actual)

January 5, 2018

Study Record Updates

Last Update Posted (Actual)

January 5, 2018

Last Update Submitted That Met QC Criteria

December 28, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRO09120363

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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