Cystic Fibrosis
Conditions
Keywords
thick mucus, obstructive lung disease
Brief 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.
Detailed 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.
Interventions
DRUGhypertonic bicarbonate
8.4% sodium bicarbonate inhaled
DRUGsodium chloride
7% sodium chloride inhaled
Sponsors
Cystic Fibrosis Foundation
Joseph Pilewski
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Exhaled breath condensate pH change | two time points (baseline and four (4) hours) | Change in pH after inhalation of two doses on one day |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Expectorated sputum change | two time points (Baseline and four (4) hours) | Change in sputum wet-to-dry ratio ratio after inhalation of two doses on one day |
| Spirometry | two time points (baseline and four (4) hours) | FEV1 before and after inhalation of two doses on one day |
Countries
United States
Outcome results
None listed