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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.
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
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2015-07 |
| Est. Completion | 2017-09 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗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.
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