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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This study has been withdrawn prior to enrollment.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:
ClinicalTrials.gov Identifier:
NCT00771706
First Posted: October 13, 2008
Last Update Posted: April 20, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Massachusetts Eye and Ear Infirmary
  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 (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:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: October 10, 2008
First Posted: October 13, 2008
Last Update Posted: April 20, 2012
Last Verified: April 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