Trials / Terminated
TerminatedNCT01841307
Cromolyn Detection of Silent Aspiration
Development and Validation of Test for Gastro-esophageal Reflux and Aspiration
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 16 (actual)
- Sponsor
- University of California, San Francisco · Academic / Other
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Cromolyn Sodium |
Timeline
- Start date
- 2015-07-01
- Primary completion
- 2017-03-01
- Completion
- 2017-09-01
- First posted
- 2013-04-26
- Last updated
- 2019-02-15
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01841307. Inclusion in this directory is not an endorsement.