Effects of Inhaled Bicarbonate on Airway pH in Cystic Fibrosis

Cystic Fibrosis Clinical Trial

Official title:

Effects of Inhaled Bicarbonate on Airway pH in Cystic Fibrosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03391414
• Other study ID #: PRO09120363
• Status: Completed
• Phase: Phase 1
• First received: June 20, 2012
• Last updated: December 28, 2017
• Start date: August 2014
• Est. completion date: July 2016

Study information

• Verified date: December 2017
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

Drug:
• hypertonic bicarbonate
8.4% sodium bicarbonate inhaled
• sodium chloride
7% sodium chloride inhaled

Locations

Country	Name	City	State
United States	Children's Hospital of Pittsburgh of UPMC	Pittsburgh	Pennsylvania
United States	UPMC Fallk Clinic	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Joseph Pilewski	Cystic Fibrosis Foundation Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Expectorated sputum change	Change in sputum wet-to-dry ratio ratio after inhalation of two doses on one day	two time points (Baseline and four (4) hours)
Secondary	Spirometry	FEV1 before and after inhalation of two doses on one day	two time points (baseline and four (4) hours)