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Cromolyn Detection of Silent Aspiration

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified July 2014 by University of California, San Francisco
Sponsor:
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: July 2, 2014
Last verified: July 2014
History of Changes
  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. 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 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:

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: 15
Study Start Date: June 2014
Estimated Primary Completion Date: April 2015 (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
 Drug: Cromolyn Sodium
Other Name: Gastrocrom

  Eligibility
Ages Eligible for Study:   18 Years to 70 Years
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

Contacts
Contact: Kelsey Wollen 415-514-1539 kelsey.wollen@ucsf.edu
Contact: Kelly Norsworthy 415-502-8791 kelly.norsworthy@ucsf.edu

Locations
United States, California
UCSF Airway Clinical Research Center Not yet recruiting
San Francisco, California, United States, 94143
Sub-Investigator: Joyce Lee, MD         
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

No publications provided

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: July 2, 2014
Health Authority: United States: Federal Government
United States: Food and Drug Administration
United States: Institutional Review Board

Additional relevant MeSH terms:
Idiopathic Pulmonary Fibrosis
Pulmonary Fibrosis
Idiopathic Interstitial Pneumonias
Lung Diseases
Lung Diseases, Interstitial
Gastroesophageal Reflux
Respiratory Aspiration
Deglutition Disorders
Digestive System Diseases
Esophageal Diseases
 Esophageal Motility Disorders
Gastrointestinal Diseases
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases
Cromolyn Sodium
Anti-Asthmatic Agents
Pharmacologic Actions
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 27, 2015