Cromolyn Detection of Silent Aspiration

Idiopathic Pulmonary Fibrosis Clinical Trial

Official title:

Development and Validation of Test for Gastro-esophageal Reflux and Aspiration

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01841307
• Other study ID #: 13-11080
• Status: Terminated
• Phase: Phase 1
• Start date: July 2015
• Est. completion date: September 2017

Study information

• Verified date: February 2019
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 16
• Est. completion date: September 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• Idiopathic Interstitial Pneumonias
• Idiopathic Pulmonary Fibrosis
• Lung Transplantation
• Pulmonary Fibrosis
• Respiratory Aspiration

Intervention

Drug:
• Cromolyn Sodium

Locations

Country	Name	City	State
United States	UCSF Airway Clinical Research Center	San Francisco	California

Sponsors (3)

Lead Sponsor	Collaborator
University of California, San Francisco	Aradign Corportation, National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total cromolyn in urine collected overnight		Collected overnight (6 hours)