Effects of Inhaled Bicarbonate on Airway pH in Cystic Fibrosis

Joseph Pilewski12 enrolled

Overview

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

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Cystic Fibrosis

Interventions

hypertonic bicarbonateDRUG

8.4% sodium bicarbonate inhaled

sodium chlorideDRUG

7% sodium chloride inhaled

Eligibility

Sex: ALLMin age: 12 Years

Medical Language ↔ Plain English

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.

Locations (2)

UPMC Fallk Clinic

Pittsburgh, Pennsylvania, United States

Children's Hospital of Pittsburgh of UPMC

Pittsburgh, Pennsylvania, United States

Outcomes

Primary Outcomes

Exhaled breath condensate pH change

Change in pH after inhalation of two doses on one day

Time frame: two time points (baseline and four (4) hours)

Secondary Outcomes

Expectorated sputum change

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)

Spirometry

FEV1 before and after inhalation of two doses on one day

Time frame: two time points (baseline and four (4) hours)

Data from ClinicalTrials.gov

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