Cromolyn Detection of Silent Aspiration

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
Development and Validation of Test for Gastro-esophageal Reflux and Aspiration

Conditions
-----------------
Gastroesophageal Reflux, Respiratory Aspiration, Idiopathic Pulmonary Fibrosis, Lung Transplantation

Intervention / Treatment
-----------------
* Drug: Cromolyn Sodium


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy participants Adult non-smokers Females only - negative urine pregnancy test Lung transplant patients Adult patients awaiting (or recently undergone) - lung transplant Evidence of gastro-esophageal reflux with probable recurrent aspiration Females only - negative urine pregnancy test Idiopathic pulmonary fibrosis patients Adult patients currently enrolled in on-going University of California, San Francisco study of prevalence of recurrent GER with aspiration in idiopathic pulmonary fibrosis Evidence of gastro-esophageal reflux with probable recurrent aspiration Females only - negative urine pregnancy test Exclusion criteria: Healthy participants History of dysphagia GER Recurrent cough Asthma Pneumonia after childhood Sleep impairment Use of drugs or alcohol impairing consciousness Impaired gag reflex on physical examination Any other significant medical illness (e.g., morbid obesity, diabetes, neurologic disease, etc.) that in the opinion of the investigator could affect the clinical features measured, responses to the therapies to be given in this study, or risks of participating in the study Greater than 5 pack years lifetime smoking history History of intolerance or allergy to cromolyn sodium Lung transplant patients History of intolerance or allergy to cromolyn sodium History of Nissen fundoplication IPF patients History of intolerance or allergy to cromolyn sodium History of Nissen fundoplication

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gastrocrom<br>4 ingestions (at 2h intervals) of a 200 mL of a 1mg/mL solution of cromolyn sodium (inpatient) OR 2 ingestions (at 4h intervals) of a 200 mL of a 1mg/mL solution of cromolyn sodium (outpatient) | Drug: Cromolyn Sodium<br> <br> * Other names: Gastrocrom;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total cromolyn in urine collected overnight |  | Collected overnight (6 hours) |