Gastroesophageal reflux disease (GERD) is a common problem in cystic fibrosis (CF). It may lead to worsening lung function and more respiratory infections for a person with CF. This study will look at treating GERD with a medication, esomeprazole. The medication stops stomach acid from being made. The study will see if there are fewer respiratory infections and improved lung function in patients with CF when taking esomeprazole.
This is a randomized, placebo controlled intervention study in patients with CF who have a history of frequent exacerbations. Treatment duration is 6 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
21
Sugar pill
Columbia University Cystic Fibrosis Center
New York, New York, United States
Time to First Pulmonary Exacerbation
Time to need for oral or intravenous antibiotics for treatment of a pulmonary exacerbation is the primary outcome measure.
Time frame: 36 weeks
Forced Expiratory Volume in One Second (FEV1)
Forced Expiratory Volume in one second (FEV1) as measured by spirometry
Time frame: 36 weeks
Forced Vital Capacity (FVC)
Forced Vital Capacity percent predicted
Time frame: 36 weeks
Number of Exacerbations
Exacerbation defined as initiation of treatment with intravenous or oral antibiotics for 7 or more days based on respiratory symptoms
Time frame: 36 weeks
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