Longitudinal Study of Children With a Chronic Cough and the Impact of Gastroesophageal Reflux
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| ClinicalTrials.gov Identifier: NCT00771706 |
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Recruitment Status :
Withdrawn
(This study was not activated, no data was collected.)
First Posted : October 13, 2008
Last Update Posted : April 20, 2012
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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 or disease | Intervention/treatment | Phase |
|---|---|---|
| Cough Gastroesophageal Reflux | Drug: Proton Pump Inhibitor Drug: Placebo | Phase 3 |
Show Detailed Description
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 0 participants |
| 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 |
| Study Start Date : | January 2006 |
| Actual Primary Completion Date : | October 2008 |
| Actual Study Completion Date : | October 2008 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Proton Pump Inhibitor
To compare the cough reduction rate using either PPI or placebo in children with a chronic cough.
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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 |
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Placebo Comparator: Sugar Pill
To compare the cough reduction rate using either PPI or placebo in children with a chronic cough
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Drug: Placebo
To compare the cough reduction rate using either PPI or placebo in children with a chronic cough. |
- 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.
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| Ages Eligible for Study: | 2 Years to 18 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
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
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
| Principal Investigator: | Christopher J Hartnick, MD | Massachusetts Eye and Ear Infirmary |
| Responsible Party: | Massachusetts Eye and Ear Infirmary |
| ClinicalTrials.gov Identifier: | NCT00771706 History of Changes |
| Other Study ID Numbers: |
04-12-076 |
| First Posted: | October 13, 2008 Key Record Dates |
| Last Update Posted: | April 20, 2012 |
| Last Verified: | April 2012 |
Keywords provided by Massachusetts Eye and Ear Infirmary:
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Pediatric Cough, Quality of Life Drug (including placebo) |
Additional relevant MeSH terms:
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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 |