This study will test the hypothesis that treatment with laparoscopic anti-reflux surgery in subjects with idiopathic pulmonary fibrosis (IPF) and abnormal gastroesophageal reflux (GER) will slow the decline of forced vital capacity (FVC) over 48 weeks.
This protocol proposes to test the following hypothesis: Treatment with laparoscopic anti-reflux surgery in subjects with idiopathic pulmonary fibrosis (IPF) and abnormal gastroesophageal (GER) reflux will slow the decline of forced vital capacity (FVC) over 48 weeks. This study will randomize approximately 58 subjects with IPF and abnormal acid reflux on 24-hour impedance / pH monitoring to laparoscopic anti-reflux surgery or standard care (randomization ratio 1:1). Subjects will be followed for 48 weeks or until the time of lung transplantation or death. We aim to achieve the following: determine the impact of laparoscopic anti-reflux surgery on change in FVC over 48 weeks in patients with IPF and abnormal GER; correlate the reduction in acid and non-acid reflux events with the change in FVC over 48 weeks in patients with IPF and abnormal GER; determine the safety of laparoscopic anti-reflux surgery in patients with IPF and abnormal GER; explore the impact of laparoscopic anti-reflux surgery on key secondary endpoints over 48 weeks in patients with IPF and abnormal GER; identify molecular markers of IPF disease activity and gastroesophageal reflux in biological samples from patients with IPF and abnormal GER.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
58
Full fundoplication surgery for the treatment of abnormal GER
University of California
San Francisco, California, United States
University of Chicago
Chicago, Illinois, United States
University of Michigan
Ann Arbor, Michigan, United States
University of Washington
Seattle, Washington, United States
Forced Vital Capacity (FVC)
Change in FVC (in liters) between enrollment and 48 weeks.
Time frame: Baseline and 48 weeks
Change in Score From Baseline for Acid and Non-acid Reflux Events at 48 Weeks
Change in acid and non-acid reflux events from baseline to week 48. All subjects answered questions related to their reflux using a Likert scale (0 = never, 1 =occasionally, 2 = sometimes, 3 = often, 4 = always).
Time frame: Baseline and 48 weeks
Safety of Laparoscopic Anti-reflux Surgery
Overall safety of laparoscopic anti-reflux surgery in patients with IPF and abnormal GER as measured by number of participants who experienced death, serious adverse event, or other (not including serious) adverse event. See Adverse Events section for additional details.
Time frame: 48 weeks
All-cause Mortality
Impact of anti-reflux surgery on all-cause mortality from enrollment to 48 weeks
Time frame: 48 weeks
Non-elective Hospitalization
Impact on non-elective hospitalizations from baseline to 48 weeks.
Time frame: Baseline and 48 weeks
Acute Exacerbations
Impact on acute exacerbations of IPF from baseline to week 48.
Time frame: Baseline and 48 weeks
University of California San Diego (UCSD) Shortness of Breath Questionnaire (SOQB) Score
Change in UCSD SOQB score from baseline to week 48. The score range is 0-120. Higher scores indicate higher breathlessness.
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University of Wisconsin
Madison, Wisconsin, United States
Time frame: Baseline and 48 weeks
St. George's Respiratory Questionnaire (SGRQ) Score
Change in SGRQ score from baseline to week 48. The score range is 0-100. Higher scores indicate more limitations.
Time frame: Baseline and 48 weeks
6-minute Walk Distance
Change in 6-minute walk distance from baseline to week 48
Time frame: Baseline and 48 weeks
Cough Visual Analog Scale (VAS)
Change in VAS from baseline to week 48. The scale range is 1-100. Lower scores indicate no cough and 100 indicates the worst cough.
Time frame: Baseline and 48 weeks
High-Resolution CT (HRCT) Fibrosis Score.
Change in HRCT fibrosis score from baseline to week 48. HRCT Fibrosis score is calculated as a percentage. Higher percentage indicates more fibrosis.
Time frame: Baseline to 48 weeks