Cromolyn Detection of Silent Aspiration

NCT ID: NCT01841307

Last Updated: 2019-02-15

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-31
• Study Completion Date: 2017-09-30

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.

Conditions

Gastroesophageal Reflux; Respiratory Aspiration; Idiopathic Pulmonary Fibrosis; Lung Transplantation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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)

Group Type: EXPERIMENTAL

Cromolyn Sodium

Intervention Type: DRUG

Interventions

Cromolyn Sodium

Intervention Type: DRUG

Other Intervention Names

Gastrocrom

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Aradign Corportation

UNKNOWN

Sponsor Role: collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Homer Boushey, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

UCSF Airway Clinical Research Center

San Francisco, California, United States

Countries

United States

Other Identifiers

13-11080

Identifier Type: -

Identifier Source: org_study_id