Cromolyn Detection of Silent Aspiration

February 12, 2019 updated by: University of California, San Francisco

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94143
        • UCSF Airway Clinical Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Gastrocrom
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
Other Names:
  • Gastrocrom

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Total cromolyn in urine collected overnight
Time Frame: Collected overnight (6 hours)
Collected overnight (6 hours)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)
Aradign Corportation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 1, 2015

Primary Completion (ACTUAL)

March 1, 2017

Study Completion (ACTUAL)

September 1, 2017

Study Registration Dates

First Submitted

April 23, 2013

First Submitted That Met QC Criteria

April 25, 2013

First Posted (ESTIMATE)

April 26, 2013

Study Record Updates

Last Update Posted (ACTUAL)

February 15, 2019

Last Update Submitted That Met QC Criteria

February 12, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13-11080

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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