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Cromolyn Detection of Silent Aspiration

Primary Purpose

Gastroesophageal Reflux, Respiratory Aspiration, Idiopathic Pulmonary Fibrosis

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Cromolyn Sodium
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Gastroesophageal Reflux

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • UCSF Airway Clinical Research Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Gastrocrom

Arm Description

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)

Outcomes

Primary Outcome Measures

Total cromolyn in urine collected overnight

Secondary Outcome Measures

Full Information

First Posted
April 23, 2013
Last Updated
February 12, 2019
Sponsor
University of California, San Francisco
Collaborators
Aradign Corportation, National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT01841307
Brief Title
Cromolyn Detection of Silent Aspiration
Official Title
Development and Validation of Test for Gastro-esophageal Reflux and Aspiration
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Terminated
Why Stopped
Difficulty recruiting; Funding ended; interim analysis provided sufficient data for interpretation.
Study Start Date
July 2015 (Actual)
Primary Completion Date
March 2017 (Actual)
Study Completion Date
September 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
Aradign Corportation, National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroesophageal Reflux, Respiratory Aspiration, Idiopathic Pulmonary Fibrosis, Lung Transplantation

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Gastrocrom
Arm Type
Experimental
Arm Description
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)
Intervention Type
Drug
Intervention Name(s)
Cromolyn Sodium
Other Intervention Name(s)
Gastrocrom
Primary Outcome Measure Information:
Title
Total cromolyn in urine collected overnight
Time Frame
Collected overnight (6 hours)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Homer Boushey, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCSF Airway Clinical Research Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States

12. IPD Sharing Statement

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Cromolyn Detection of Silent Aspiration

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