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

NCT00771706 | Withdrawn Phase 3

• 1 other identifier: 04-12-076
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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 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.

Conditions

Cough; Gastroesophageal Reflux

Keywords

Pediatric Cough, Quality of Life; Drug (including placebo)

Outcome Measures

Primary Outcomes (1)

• No primary outcome measure.

  There is no primary outcome measure as this study was not activated. Therefore, no data was collected to measure or analyze.

  No timeframe.

Study Arms (2)

Proton Pump Inhibitor

EXPERIMENTAL

To compare the cough reduction rate using either PPI or placebo in children with a chronic cough.

Drug: Proton Pump Inhibitor

Sugar Pill

PLACEBO COMPARATOR

To compare the cough reduction rate using either PPI or placebo in children with a chronic cough

Drug: Placebo

Interventions

Proton Pump Inhibitor DRUG

The PPI arm will consist of a two week course of PPI at a dose 1mg/kg/dose twice daily (minimum dose: 7.5 mg BID; maximum dose: 30 mg BID)

Also known as: PPI

Proton Pump Inhibitor

Placebo DRUG

To compare the cough reduction rate using either PPI or placebo in children with a chronic cough.

Sugar Pill

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts Eye and Ear Infirmary: lead

MeSH Terms

Conditions

Cough; Gastroesophageal Reflux

Interventions

Proton Pump Inhibitors

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Christopher J Hartnick, MD

  Massachusetts Eye and Ear Infirmary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2008
• First Posted: October 13, 2008
• Study Start: January 1, 2006
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2008
• Last Updated: April 20, 2012

Record last verified: 2012-04