A Randomized, Double-Blind, Placebo-Controlled Study of Gastroesophageal Reflux Disease Therapy.

NCT00237068 | Unknown Phase 4 DMC

• 1 other identifier: GERD AsthmaStudy
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 3

Brief Summary

Asthma and gastroesophageal reflux disease (GERD) are common disorders, which although are not usually lethal, both have high morbidity, and high healthcare costs. Recent studies have demonstrated that asthma and GERD often co-exists, and that this co-existence is more frequent than just chance. Therefore, studies that characterize associations between these conditions, and, help in the development of interventions will positively impact the outcomes of these patients, which are critically needed. Subjects that participate in this study are required to be between the ages of 4-11 years old. This protocol proposes to enroll 100 children with asthma, on inhaled steroids who have poor asthma control, defined on the basis of frequent symptoms, excessive beta-agonists use, or frequent asthma episodes. The purpose of this research study is to:

1. 1.Determine, whether children with symptomatic, poorly controlled, asthma assigned to treatment with a PPI( Proton Pump Inhibitor), have fewer asthma exacerbations than similar participants assigned to placebo for a similar duration of time
2. 2.Determine whether children treated with Lansoprazole ( i.e., proton pump inhibitor): have a longer time to first exacerbation, have improved lung function, improved asthma symptom scores, improved quality of life, decreased rescue inhaler use, or other asthma medications, reduced emergency room/urgent care/ physician office visits that are asthma related.
3. 3.Determine whether a subgroup of symptomatic asthmatics, who show a greater benefit from PPI's, can be identified.

Conditions

Asthma

Keywords

Gastroesophageal Reflux

Outcome Measures

Primary Outcomes (1)

• One of the aims of this trial is to see if we can demonstrate a significant response to acid-suppression therapy in a group of poorly controlled childhood asthmatics using the number of asthma exacerbations as outcome variables.

  3 year

Secondary Outcomes (1)

• A major unanswered question is whether severity or frequency of asthma is related to the response to anti-reflux treatment.

  3 year

Interventions

Lansoprazole; Solutab DRUG

15 and 30 mg doses of dissolvable tablet, 2 tablets daily for one year

Also known as: Prevacid

Eligibility Criteria

• Age: 4 Years - 11 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• years Informed Consent/ Assent Asthma Clinically normal laboratory results and physical exam

You may not qualify if:

• Unable or unwilling to give informed consent Unable to comply with study protocol Any preexisting condition that would require A PPI for a period of 6 months or more and/other major chronic illnesses.
• Drug Allergies toPPI. At High risk for non-compliance and/or adherence.

Sponsors & Collaborators

• Emory University: lead

Study Sites (3)

Emory Children's Center

Atlanta, Georgia, 30322, United States

Location

Children's Center for Digestive Healthcare

Atlanta, Georgia, 30342, United States

Location

Georgia Pediatric Pulmonology Associates/ CHOA

Atlanta, Georgia, 30342, United States

Location

MeSH Terms

Conditions

Asthma; Gastroesophageal Reflux

Interventions

Lansoprazole

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Benjamin D. Gold, MD.

  Emory University School of Medicine / Pediatrics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 11, 2005
• First Posted: October 12, 2005
• Study Start: March 1, 2006
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2010
• Last Updated: March 16, 2011

Record last verified: 2011-03

Locations

US (3)