Longitudinal Study of Children With a Chronic Cough and the Impact of Gastroesophageal Reflux

• Status: Withdrawn
• Trial end date: 2008-10-01
• Target enrollment: 0
• Participant gender: All

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 diagnosis is broad, including self-limited, persistent, and chronic diseases. The success of a given treatment depends upon a proper diagnosis, yet this is often not obvious. Gastroesophageal reflux (GER) has been proposed as one possible etiology of a chronic cough in a number of studies in the adult literature; nevertheless a clear cause and effect remains to be confirmed as there continues to be no gold standard test definitively to identify pathologic GER. Each year, billions of dollars are directed towards diagnosing and treating GER as it relates to adults and children with a chronic cough but without solid proof of effect.

We propose to test the null hypothesis that there is no causative role of GER with regards to the etiology of chronic cough in children. If the null hypothesis proves true, this has important medical and economic ramifications, as it would suggest that treatment of acid reflux for chronic cough in a child is unwarranted. With this conclusion, health care costs would be reduced and children spared inappropriate medication.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Massachusetts Eye and Ear Infirmary
• Treatments: Proton Pump Inhibitors

Criteria

Inclusion Criteria:

1. Children 2-18 years of age

2. Male and female children

3. Children of any race or ethnicity

4. 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 Criteria:

1. The presence of a chronic respiratory, neurological or gastrointestinal disease and/or anomaly

2. An abnormal barium swallow study indicating vascular compression

3. Allergy with respiratory component,

4. Gross erosive esophagitis defined by EGD findings where patients will automatically be placed on PPI therapy without randomization