Cromolyn Detection of Silent Aspiration (NCT01841307) | Clinical Trial Compass
TerminatedPhase 1
Cromolyn Detection of Silent Aspiration
Stopped: Difficulty recruiting; Funding ended; interim analysis provided sufficient data for interpretation.
United States16 participantsStarted 2015-07
Plain-language 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.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 fun…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.