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Cromolyn Detection of Silent Aspiration

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Yes
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 70 Years
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT01841307
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 1
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	University of California, San Francisco
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Homer Boushey, MD
Principal Investigator Affiliation	University of California, San Francisco
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other, NIH
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Gastroesophageal Reflux, Respiratory Aspiration, Idiopathic Pulmonary Fibrosis, Lung Transplantation

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

UCSF Airway Clinical Research Center, San Francisco, California

Status

Recruiting

Address

UCSF Airway Clinical Research Center

San Francisco, California, 94143

Site Contact

Andrew M Manies, A.B.

andrew.manies@ucsf.edu

415-353-1210