Cromolyn Detection of Silent Aspiration
| Status: | Terminated |
|---|---|
| Conditions: | Gastroesophageal Reflux Disease , Hospital, Pulmonary |
| Therapuetic Areas: | Gastroenterology, Pulmonary / Respiratory Diseases, Other |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 2/17/2019 |
| Start Date: | July 2015 |
| End Date: | September 2017 |
Development and Validation of Test for Gastro-esophageal Reflux and Aspiration
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.
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.
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
We found this trial at
1
site
San Francisco, California 94143
Principal Investigator: Homer A Boushey, M.D.
Phone: 415-476-8019
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