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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Last refreshed on: 8 January 2018
Main ID:  NCT03391414
Date of registration: 20/06/2012
Prospective Registration: Yes
Primary sponsor: Joseph Pilewski
Public title: Effects of Inhaled Bicarbonate on Airway pH in Cystic Fibrosis
Scientific title: Effects of Inhaled Bicarbonate on Airway pH in Cystic Fibrosis
Date of first enrolment: August 2014
Target sample size: 12
Recruitment status: Completed
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Basic Science. Masking: None (Open Label).  
Phase:  Phase 1
Countries of recruitment
United States
Name:     Joseph M PIlewski, MD
Affiliation:  University of Pittsburgh
Key inclusion & exclusion criteria

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

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.

Age minimum: 12 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Cystic Fibrosis
Drug: hypertonic bicarbonate
Drug: sodium chloride
Primary Outcome(s)
Exhaled breath condensate pH change [Time Frame: two time points (baseline and four (4) hours)]
Secondary Outcome(s)
Expectorated sputum change [Time Frame: two time points (Baseline and four (4) hours)]
Spirometry [Time Frame: two time points (baseline and four (4) hours)]
Secondary ID(s)
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Cystic Fibrosis Foundation Therapeutics
Ethics review
Results available:
Date Posted:
Date Completed:
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