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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT01841307 |
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Date of registration:
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23/04/2013 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Cromolyn Detection of Silent Aspiration
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Scientific title:
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Development and Validation of Test for Gastro-esophageal Reflux and Aspiration |
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Date of first enrolment:
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July 2015 |
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Target sample size:
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16 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT01841307 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
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Phase:
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Phase 1
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Countries of recruitment
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United States
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Contacts
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Name:
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Homer Boushey, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of California, San Francisco |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Idiopathic Pulmonary Fibrosis
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Gastroesophageal Reflux
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Respiratory Aspiration
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Lung Transplantation
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Intervention(s)
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Drug: Cromolyn Sodium
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Primary Outcome(s)
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Total cromolyn in urine collected overnight
[Time Frame: Collected overnight (6 hours)]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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