Status:
TERMINATED
Cromolyn Detection of Silent Aspiration
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
Aradign Corportation
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Gastroesophageal Reflux
Respiratory Aspiration
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
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 i...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
July 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2017
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT01841307
Start Date
July 1 2015
End Date
September 1 2017
Last Update
February 15 2019
Active Locations (1)
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1
UCSF Airway Clinical Research Center
San Francisco, California, United States, 94143