Cromolyn Detection of Silent Aspiration

Phase 1

Terminated

• Conditions: Idiopathic Pulmonary Fibrosis; Respiratory Aspiration; Gastroesophageal Reflux; Lung Transplantation
• Interventions: Drug: Cromolyn Sodium

• Registration Number: NCT01841307
• Lead Sponsor: University of California, San Francisco

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-04-23
• Study First Submitted QC: 2013-04-25
• Study First Posted: 2013-04-26
• Study Start: 2015-07
• Primary Completion: 2017-03
• Study Completion: 2017-09
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-12
• Last Update Posted: 2019-02-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 16

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Gastrocrom	Cromolyn Sodium	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)

Primary Outcome Measures

Name	Time	Method
Total cromolyn in urine collected overnight	Collected overnight (6 hours)

Trial Locations

Locations (1)

UCSF Airway Clinical Research Center; 🇺🇸 San Francisco, California, United States