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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This study has been withdrawn prior to enrollment.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 (Subject, 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. ] [ Designated as safety issue: No ]
    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
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
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

No publications provided

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
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts Eye and Ear Infirmary:
Pediatric Cough, Quality of Life
Drug (including placebo)

Additional relevant MeSH terms:
Cough
Gastroesophageal Reflux
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Esophageal Motility Disorders
Deglutition Disorders
 Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013