Cromolyn Detection of Silent Aspiration

Phase 1TerminatedNCT01841307

University of California, San Francisco16 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Gastroesophageal Reflux Respiratory Aspiration Idiopathic Pulmonary Fibrosis

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Cromolyn Detection of Silent Aspiration

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes