Status:
WITHDRAWN
Longitudinal Study of Children With a Chronic Cough and the Impact of Gastroesophageal Reflux
Lead Sponsor:
Massachusetts Eye and Ear Infirmary
Conditions:
Cough
Gastroesophageal Reflux
Eligibility:
All Genders
2-18 years
Phase:
PHASE3
Brief Summary
Cough is both an important physiologic component of lung defense and a cardinal indicator of disease. For those with chronic cough, defined as cough lasting for more than 3 weeks, the differential dia...
Detailed Description
Introduction 1.1. Cough Cough is both an important physiologic component of lung defense and a cardinal indicator of disease. It is the second most common reason for medical visits during childhood....
Eligibility Criteria
Inclusion
- Children 2-18 years of age
- Male and female children
- Children of any race or ethnicity
- Cough lasting longer than three weeks\* \* If a child has been placed on PPI or other antacid therapy for presumed but not documented extra-esophageal manifestations of GER, then these children will stop taking their antacid therapy after recruitment for the two-week interval between recruitment and the endoscopy, as is the standard protocol at MEEI to allow time for adequate "wash-out" prior to endoscopy and pH probe placement.
Exclusion
- The presence of a chronic respiratory, neurological or gastrointestinal disease and/or anomaly
- An abnormal barium swallow study indicating vascular compression
- Allergy with respiratory component,
- Gross erosive esophagitis defined by EGD findings where patients will automatically be placed on PPI therapy without randomization
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00771706
Start Date
January 1 2006
End Date
October 1 2008
Last Update
April 20 2012
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