Effects of Inhaled Bicarbonate on Airway pH in Cystic Fibrosis

NCT03391414 | Completed Phase 1

• 1 other identifier: PRO09120363
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 2

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.

Conditions

Cystic Fibrosis

Keywords

thick mucus; obstructive lung disease

Outcome Measures

Primary Outcomes (1)

• Exhaled breath condensate pH change

  Change in pH after inhalation of two doses on one day

  two time points (baseline and four (4) hours)

Secondary Outcomes (2)

• Expectorated sputum change

  two time points (Baseline and four (4) hours)

• Spirometry

  two time points (baseline and four (4) hours)

Study Arms (2)

hypertonic bicarbonate

EXPERIMENTAL

subjects will be administered a solution of 8.4% hypertonic bicarbonate by nebulizer

Drug: hypertonic bicarbonate

hypertonic saline

ACTIVE COMPARATOR

subjects will be administered a solution of 7% sodium chloride by nebulizer

Drug: sodium chloride

Interventions

hypertonic bicarbonate DRUG

8.4% sodium bicarbonate inhaled

Also known as: sodium bicarbonate

hypertonic bicarbonate

sodium chloride DRUG

7% sodium chloride inhaled

Also known as: hyper-sal

hypertonic saline

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• FEV1 greater than 50% predicted.
• Ability to spontaneously expectorate sputum (with or without chest physiotherapy).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Joseph Pilewski: lead
• Cystic Fibrosis Foundation: collaborator

Study Sites (2)

UPMC Fallk Clinic

Pittsburgh, Pennsylvania, 15213, United States

Location

Children's Hospital of Pittsburgh of UPMC

Pittsburgh, Pennsylvania, 15224, United States

Location

MeSH Terms

Conditions

Cystic Fibrosis; Lung Diseases, Obstructive

Interventions

Sodium Bicarbonate; Sodium Chloride

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Intervention Hierarchy (Ancestors)

Bicarbonates; Carbonates; Carbonic Acid; Carbon Compounds, Inorganic; Inorganic Chemicals; Sodium Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds

Study Officials

• Joseph M PIlewski, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Medicine and Pediatrics

Study Record Dates

• First Submitted: June 20, 2012
• First Posted: January 5, 2018
• Study Start: August 1, 2014
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: January 5, 2018

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)