Cromolyn Detection of Silent Aspiration

NCT01841307 | Terminated Phase 1

• 1 other identifier: 13-11080
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastroesophageal Reflux; Respiratory Aspiration; Idiopathic Pulmonary Fibrosis; Lung Transplantation

Outcome Measures

Primary Outcomes (1)

• Total cromolyn in urine collected overnight

  Collected overnight (6 hours)

Study Arms (1)

Gastrocrom

EXPERIMENTAL

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

Interventions

Cromolyn Sodium DRUG

Also known as: Gastrocrom

Gastrocrom

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead
• Aradign Corportation: collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

UCSF Airway Clinical Research Center

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Gastroesophageal Reflux; Respiratory Aspiration; Idiopathic Pulmonary Fibrosis

Interventions

Cromolyn Sodium

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases

Intervention Hierarchy (Ancestors)

Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Homer Boushey, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2013
• First Posted: April 26, 2013
• Study Start: July 1, 2015
• Primary Completion: March 1, 2017
• Study Completion: September 1, 2017
• Last Updated: February 15, 2019

Record last verified: 2019-02

Locations

US (1)