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Completed

NCT Number: NCT03391414

Effects of Inhaled Bicarbonate on Airway pH in Cystic Fibrosis

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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Key information

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Children's Hospital of Pittsburgh of UPMC, Pittsburgh, Pennsylvania, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • FEV1 greater than 50% predicted.
  • Ability to spontaneously expectorate sputum (with or without chest physiotherapy).
  • Stable disease as defined by absence of exclusion criteria numbers 3-5 and clinician assessment.

Exclusion criteria

  • 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.

Treatment and study plan

hypertonic bicarbonate

Drug

8.4% sodium bicarbonate inhaled

Other names: sodium bicarbonate

Sodium Chloride

Drug

7% sodium chloride inhaled

Other names: hyper-sal

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. Spirometry

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

    FEV1 before and after inhalation of two doses on one day

Sponsors and collaborators

Lead sponsor

Joseph Pilewski

Other

Collaborators

  • Cystic Fibrosis Foundation

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jan 5, 2018
Registry last updated
Jan 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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