Cromolyn Detection of Silent Aspiration
This study is currently recruiting participants.
(see Contacts and Locations)
Verified August 2016 by University of California, San Francisco
Sponsor:
University of California, San Francisco
Collaborators:
Aradign Corportation
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01841307
First received: April 23, 2013
Last updated: August 10, 2016
Last verified: August 2016
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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.
| Condition | Intervention | Phase |
|---|---|---|
|
Gastroesophageal Reflux Respiratory Aspiration Idiopathic Pulmonary Fibrosis Lung Transplantation |
Drug: Cromolyn Sodium |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Pharmacokinetics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | Development and Validation of Test for Gastro-esophageal Reflux and Aspiration |
Resource links provided by NLM:
Genetics Home Reference related topics:
idiopathic pulmonary fibrosis
pulmonary alveolar microlithiasis
U.S. FDA Resources
Further study details as provided by University of California, San Francisco:
Primary Outcome Measures:
- Total cromolyn in urine collected overnight [ Time Frame: Collected overnight (6 hours) ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 20 |
| Study Start Date: | June 2014 |
| Estimated Study Completion Date: | July 2017 |
| Estimated Primary Completion Date: | April 2017 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations
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, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01841307
Please refer to this study by its ClinicalTrials.gov identifier: NCT01841307
Contacts
| Contact: Andrew M Manies | 415-353-1210 | andrew.manies@ucsf.edu | |
| Contact: Julian Silva | 415-476-5418 | julian.silva@ucsf.edu |
Locations
| 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. | |
Sponsors and Collaborators
University of California, San Francisco
Aradign Corportation
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
| Principal Investigator: | Homer Boushey, MD | University of California, San Francisco |
More Information
| Responsible Party: | University of California, San Francisco |
| ClinicalTrials.gov Identifier: | NCT01841307 History of Changes |
| Other Study ID Numbers: | 13-11080 |
| Study First Received: | April 23, 2013 |
| Last Updated: | August 10, 2016 |
| Health Authority: | United States: Federal Government United States: Food and Drug Administration United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Idiopathic Pulmonary Fibrosis Idiopathic Interstitial Pneumonias Pulmonary Fibrosis Lung Diseases, Interstitial Lung Diseases 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 |
ClinicalTrials.gov processed this record on September 29, 2016