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

This study has been withdrawn prior to enrollment.

(This study was not activated, no data was collected.)

Sponsor:

Information provided by (Responsible Party):

Massachusetts Eye and Ear Infirmary

ClinicalTrials.gov Identifier:

NCT00771706

First received: October 10, 2008

Last updated: April 19, 2012

Last verified: April 2012

History of Changes

Purpose

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.

Condition	Intervention	Phase
Cough Gastroesophageal Reflux	Drug: Proton Pump Inhibitor Drug: Placebo	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Single Group Assignment Masking: Double Blind (Participant, Investigator) Primary Purpose: Treatment
Official Title:	Longitudinal Study of Children With a Chronic Cough and the Impact of Gastroesophageal Reflux

Resource links provided by NLM:

MedlinePlus related topics: Cough GERD

U.S. FDA Resources

Further study details as provided by Massachusetts Eye and Ear Infirmary:

Primary Outcome Measures:

No primary outcome measure. [ Time Frame: No timeframe. ]
There is no primary outcome measure as this study was not activated. Therefore, no data was collected to measure or analyze.


Enrollment:	0
Study Start Date:	January 2006
Study Completion Date:	October 2008
Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Proton Pump Inhibitor To compare the cough reduction rate using either PPI or placebo in children with a chronic cough.	Drug: Proton Pump Inhibitor 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) Other Name: PPI
Placebo Comparator: Sugar Pill To compare the cough reduction rate using either PPI or placebo in children with a chronic cough	Drug: Placebo To compare the cough reduction rate using either PPI or placebo in children with a chronic cough.

Show Detailed Description

Eligibility


Ages Eligible for Study:	2 Years to 18 Years (Child, Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

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 Criteria:

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00771706

Sponsors and Collaborators

Massachusetts Eye and Ear Infirmary

Investigators


Principal Investigator:	Christopher J Hartnick, MD	Massachusetts Eye and Ear Infirmary

More Information


Responsible Party:	Massachusetts Eye and Ear Infirmary
ClinicalTrials.gov Identifier:	NCT00771706 History of Changes
Other Study ID Numbers:	04-12-076
Study First Received:	October 10, 2008
Last Updated:	April 19, 2012

Keywords provided by Massachusetts Eye and Ear Infirmary:


Pediatric Cough, Quality of Life Drug (including placebo)

Additional relevant MeSH terms:


Gastroesophageal Reflux Cough Esophageal Motility Disorders Deglutition Disorders Esophageal Diseases Gastrointestinal Diseases Digestive System Diseases	Respiration Disorders Respiratory Tract Diseases Signs and Symptoms, Respiratory Signs and Symptoms Proton Pump Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 23, 2017

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