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Cromolyn Detection of Silent Aspiration

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ClinicalTrials.gov Identifier: NCT01841307
Recruitment Status : Terminated (Difficulty recruiting; Funding ended; interim analysis provided sufficient data for interpretation.)
First Posted : April 26, 2013
Last Update Posted : February 15, 2019
Sponsor:
Collaborators:
Aradign Corportation
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
University of California, San Francisco

Brief 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.

Condition or disease Intervention/treatment Phase
Gastroesophageal Reflux Respiratory Aspiration Idiopathic Pulmonary Fibrosis Lung Transplantation Drug: Cromolyn Sodium Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 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
Actual Study Start Date : July 2015
Actual Primary Completion Date : March 2017
Actual Study Completion Date : September 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




Primary Outcome Measures :
  1. Total cromolyn in urine collected overnight [ Time Frame: Collected overnight (6 hours) ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

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


Locations
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United States, California
UCSF Airway Clinical Research Center
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
Aradign Corportation
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Homer Boushey, MD University of California, San Francisco

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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: February 15, 2019
Last Verified: February 2019
Additional relevant MeSH terms:
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Gastroesophageal Reflux
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Idiopathic Interstitial Pneumonias
Respiratory Aspiration
Pathologic Processes
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Lung Diseases, Interstitial
Respiration Disorders
Cromolyn Sodium
Anti-Asthmatic Agents
Respiratory System Agents