Effects of Inhaled Bicarbonate on Airway pH in Cystic Fibrosis

Phase 1

Completed

• Conditions: Cystic Fibrosis
• Interventions: Drug: hypertonic bicarbonate; Drug: sodium chloride

• Registration Number: NCT03391414
• Lead Sponsor: Joseph Pilewski

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.

Study Timeline

• Study First Submitted: 2012-06-20
• Study Start: 2014-08
• Primary Completion: 2016-07
• Study Completion: 2016-07
• Status Verified: 2017-12
• Study First Submitted QC: 2017-12-28
• Last Update Submitted: 2017-12-28
• Study First Posted: 2018-01-05
• Last Update Posted: 2018-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
hypertonic bicarbonate	hypertonic bicarbonate	subjects will be administered a solution of 8.4% hypertonic bicarbonate by nebulizer
hypertonic saline	sodium chloride	subjects will be administered a solution of 7% sodium chloride by nebulizer

Primary Outcome Measures

Name	Time	Method
Exhaled breath condensate pH change	two time points (baseline and four (4) hours)	Change in pH after inhalation of two doses on one day

Secondary Outcome Measures

Name	Time	Method
Expectorated sputum change	two time points (Baseline and four (4) hours)	Change in sputum wet-to-dry ratio ratio after inhalation of two doses on one day
Spirometry	two time points (baseline and four (4) hours)	FEV1 before and after inhalation of two doses on one day

Trial Locations

Locations (2)

UPMC Fallk Clinic; 🇺🇸 Pittsburgh, Pennsylvania, United States

Children's Hospital of Pittsburgh of UPMC; 🇺🇸 Pittsburgh, Pennsylvania, United States