Effects of Inhaled Bicarbonate on Airway pH in Cystic Fibrosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2016-07-31

Brief Summary

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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.

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Detailed Description

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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

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Cystic Fibrosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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hypertonic bicarbonate

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

Group Type EXPERIMENTAL

hypertonic bicarbonate

Intervention Type DRUG

8.4% sodium bicarbonate inhaled

hypertonic saline

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

Group Type ACTIVE_COMPARATOR

sodium chloride

Intervention Type DRUG

7% sodium chloride inhaled

Interventions

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hypertonic bicarbonate

8.4% sodium bicarbonate inhaled

Intervention Type DRUG

sodium chloride

7% sodium chloride inhaled

Intervention Type DRUG

Other Intervention Names

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sodium bicarbonate hyper-sal

Eligibility Criteria

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Inclusion Criteria

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

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.

Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No