Effects of Inhaled Bicarbonate on Airway pH in Cystic Fibrosis

Completed · Phase 1

Conditions studied: Cystic Fibrosis

In brief

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.

Key facts

Study ID

NCT03391414

Run by

Joseph Pilewski

People needed

12

Starts

2014-08-01

Expected to finish

2016-07-01

Last updated by the study team

2018-01-05

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

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.

Where it is running

• UPMC Fallk Clinic — Pittsburgh, Pennsylvania, United States
• Children's Hospital of Pittsburgh of UPMC — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.