The overall purpose of this project is to develop and validate a simple, non-invasive method
to detect aspiration of gastro-intestinal fluid into the respiratory tract. In the inpatient
setting, the investigators will compare the quantity of cromolyn detected in urine collected
overnight after 4 ingestions (at 2h intervals) of a 200 mL of a 1mg/mL solution of cromolyn
sodium, by 5 healthy control subjects and 5 patients (3-6 with pulmonary fibrosis; and 3-6
either awaiting or recently undergone lung transplantation) with clinical and laboratory
evidence of GER (gastroesophageal reflux) with microaspiration. In the outpatient setting,
the investigators will compare the quantity of cromolyn detected in urine collected overnight
after 1 ingestions (at 4h intervals) of a 200 mL of a 1mg/mL solution of cromolyn sodium, by
10 patients (3-6 with pulmonary fibrosis; and 3-6 either awaiting or recently undergone lung
transplantation) with clinical and laboratory evidence of GER (gastroesophageal reflux) with
microaspiration.
Phase:
Phase 1
Details
Lead Sponsor:
University of California, San Francisco
Collaborators:
Aradign Corportation National Heart, Lung, and Blood Institute (NHLBI)