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NCT01841307 · ClinicalTrials.gov registry record · Phase 1

Cromolyn Detection of Silent Aspiration

A Phase 1 study, sponsored by University of California, San Francisco.

Terminated
Registry status
Phase 1
Development phase
16
Enrollment target

NCT01841307 is a Phase 1 study that was terminated before completion, run by University of California, San Francisco. The registered enrollment target is 16 participants.

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The verdict

NCT01841307, a Phase 1 study, was terminated before completion, sponsored by University of California, San Francisco.

TERMINATED
Registry status
Phase 1
Development phase
16 participants
Enrollment target

Study 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.

Interventions

  • DRUG Cromolyn Sodium

Trial Details

FieldValue
Enrollment Target 16 participants
Start Date 2015-07
Est. Completion 2017-09
Phase Phase 1

What the Registry Record Tells You About NCT01841307

The ClinicalTrials.gov registry entry for NCT01841307 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, San Francisco, which has 1,713 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Cromolyn Sodium is the first listed.

NCT01841307 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01841307 about?

NCT01841307 is a clinical study titled "Cromolyn Detection of Silent 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 ing...

What is the current status of trial NCT01841307?

This trial is currently terminated. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2015-07. Estimated completion is 2017-09.

What interventions are being tested in trial NCT01841307?

The interventions under investigation include: Cromolyn Sodium (DRUG).

Who is sponsoring clinical trial NCT01841307?

This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.