Cromolyn Detection of Silent Aspiration
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01841307 |
Recruitment Status
:
Recruiting
First Posted
: April 26, 2013
Last Update Posted
: August 12, 2016
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Gastroesophageal Reflux Respiratory Aspiration Idiopathic Pulmonary Fibrosis Lung Transplantation | Drug: Cromolyn Sodium | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 20 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Diagnostic |
Official Title: | Development and Validation of Test for Gastro-esophageal Reflux and Aspiration |
Study Start Date : | June 2014 |
Estimated Primary Completion Date : | April 2017 |
Estimated Study Completion Date : | July 2017 |

Arm | Intervention/treatment |
---|---|
Experimental: Gastrocrom
4 ingestions (at 2h intervals) of a 200 mL of a 1mg/mL solution of cromolyn sodium (inpatient) OR 2 ingestions (at 4h intervals) of a 200 mL of a 1mg/mL solution of cromolyn sodium (outpatient)
|
Drug: Cromolyn Sodium
Other Name: Gastrocrom
|
- Total cromolyn in urine collected overnight [ Time Frame: Collected overnight (6 hours) ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 70 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01841307
Contact: Andrew M Manies | 415-353-1210 | andrew.manies@ucsf.edu | |
Contact: Julian Silva | 415-476-5418 | julian.silva@ucsf.edu |
United States, California | |
UCSF Airway Clinical Research Center | Recruiting |
San Francisco, California, United States, 94143 | |
Contact: Andrew M Manies, A.B. 415-353-1210 andrew.manies@ucsf.edu | |
Contact: Julian Silva 415-476-5418 julian.silva@ucsf.edu | |
Principal Investigator: Homer A Boushey, M.D. |
Principal Investigator: | Homer Boushey, MD | University of California, San Francisco |
Responsible Party: | University of California, San Francisco |
ClinicalTrials.gov Identifier: | NCT01841307 History of Changes |
Other Study ID Numbers: |
13-11080 |
First Posted: | April 26, 2013 Key Record Dates |
Last Update Posted: | August 12, 2016 |
Last Verified: | August 2016 |
Additional relevant MeSH terms:
Pulmonary Fibrosis Idiopathic Pulmonary Fibrosis Idiopathic Interstitial Pneumonias Lung Diseases Lung Diseases, Interstitial Gastroesophageal Reflux Respiratory Aspiration Esophageal Motility Disorders Deglutition Disorders |
Esophageal Diseases Gastrointestinal Diseases Digestive System Diseases Respiratory Tract Diseases Respiration Disorders Pathologic Processes Cromolyn Sodium Anti-Asthmatic Agents Respiratory System Agents |