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| Sponsor: | National Heart, Lung, and Blood Institute (NHLBI) |
|---|---|
| Collaborator: |
American Lung Association Asthma Clinical Research Centers |
| Information provided by: | National Heart, Lung, and Blood Institute (NHLBI) |
| ClinicalTrials.gov Identifier: | NCT00442013 |
Purpose
Many individuals with asthma also experience gastroesophageal reflux disease (GERD), a condition in which excess stomach acid flows backwards into the esophagus. This study will evaluate the effectiveness of lansoprazole, a medication commonly used to treat GERD in improving asthma control and reducing symptoms in children with poorly controlled asthma.
| Condition | Intervention | Phase |
|---|---|---|
|
Asthma |
Drug: Lansoprazole Drug: Placebo |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Phase III: The Study of Acid Reflux in Children With Asthma |
| Estimated Enrollment: | 300 |
| Study Start Date: | March 2007 |
| Study Completion Date: | August 2011 |
| Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Participants will receive lansoprazole on a daily basis for 6 months.
|
Drug: Lansoprazole
Participants less than 30 kg will receive 15 mg a day, by mouth; participants greater than or equal to 30 kg will receive 30 mg a day, by mouth.
Other Name: Prevacid
|
|
Placebo Comparator: 2
Participants will receive placebo on a daily basis for 6 months.
|
Drug: Placebo
Participants will receive a placebo pill on a daily basis.
|
Approximately 75% of individuals with asthma also experience GERD. If left untreated, GERD can lead to lung damage, esophageal ulcers, or esophageal cancer. Children and adults whose asthma is poorly controlled with inhaled corticosteroids are often prescribed drugs that suppress gastric acid production; however, this treatment is expensive and has not been proven beneficial. Lansoprazole is a proton pump inhibitor medication that reduces stomach acid production. It may also decrease the frequency of asthma exacerbations in children with poorly controlled asthma. The purpose of this study is to evaluate the effectiveness of lansoprazole at improving asthma control, quality of life, and lung function in children with asthma.
This study will enroll children with poor asthma control who are receiving inhaled corticosteroids. Participants will be randomly assigned to receive either lansoprazole or placebo on a daily basis for 6 months. Study visits will occur at baseline and Weeks 4, 8, 12, 16, 20, and 24, and participants will be contacted by telephone at Week 2. A physical examination, blood collection, and methacholine challenge test will occur at selected visits. The methacholine challenge test will be used to help determine the severity of an individual's asthma. Lung function and airway pressure testing, questionnaires on asthma control and quality of life, medical history review, pill counts, and distribution of medication will occur at most study visits. Participants will record asthma symptoms and lung function in a daily diary throughout the study. A select group of participants will also wear an esophageal pH monitor for 24 hours to evaluate GERD symptoms and the relationship between GERD and asthma symptoms.
Eligibility| Ages Eligible for Study: | 6 Years to 17 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
At least one of the following lung function criteria must be documented in the year prior to study entry:
Poor asthma control as defined by any one of the following criteria:
Exclusion Criteria:
Contacts and Locations| United States, Alabama | |
| University of Alabama at Birmingham | |
| Birmingham, Alabama, United States, 35233 | |
| United States, California | |
| University of California San Diego | |
| San Diego, California, United States, 92103 | |
| United States, Colorado | |
| National Jewish Medical and Research Center | |
| Denver, Colorado, United States, 80206 | |
| United States, Florida | |
| Nemours Children's Clinic | |
| Jacksonville, Florida, United States, 32207 | |
| University of Miami School of Medicine | |
| Miami, Florida, United States, 33613 | |
| University of South Florida College of Medicine | |
| Tampa, Florida, United States, 33613 | |
| United States, Georgia | |
| Emory University School of Medicine | |
| Atlanta, Georgia, United States, 30322 | |
| United States, Illinois | |
| Northwestern Memorial Hospital | |
| Chicago, Illinois, United States, 60611 | |
| United States, Indiana | |
| Indiana University | |
| Indianapolis, Indiana, United States, 46202 | |
| United States, Minnesota | |
| University of Minnesota | |
| Minneapolis, Minnesota, United States, 55455 | |
| United States, Missouri | |
| University of Missouri, Kansas City School of Medicine | |
| Kansas City, Missouri, United States, 64108 | |
| Washington University School of Medicine | |
| St. Louis, Missouri, United States, 63110 | |
| United States, New York | |
| North Shore-Long Island Jewish Health System | |
| New Hyde Park, New York, United States, 11040 | |
| New York University School of Medicine | |
| New York, New York, United States, 10016 | |
| New York Medical College | |
| Valhalla, New York, United States, 10595 | |
| United States, North Carolina | |
| Duke University School of Medicine | |
| Durham, North Carolina, United States, 27710 | |
| United States, Ohio | |
| Davis Heart and Lung Research Institute | |
| Columbus, Ohio, United States, 43210 | |
| United States, Pennsylvania | |
| Penn Presbyterain Medical Center/Penn Lung Center | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| United States, Texas | |
| Baylor College of Medicine | |
| Houston, Texas, United States, 77030 | |
| United States, Vermont | |
| Vermont Lung Center at The University of Vermont | |
| Burlington, Vermont, United States, 05405 | |
| Principal Investigator: | Janet Holbrook, PhD, MPH | Johns Hopkins University School of Public Health |
| Principal Investigator: | Gerald Teague, MD | University of Virginia |
More Information
| Responsible Party: | Janet Holbrook, Johns Hopkins University |
| ClinicalTrials.gov Identifier: | NCT00442013 History of Changes |
| Other Study ID Numbers: | 454, U01 HL080450-01 |
| Study First Received: | February 28, 2007 |
| Last Updated: | November 10, 2011 |
| Health Authority: | United States: Federal Government |
|
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |
Lansoprazole Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Anti-Ulcer Agents Gastrointestinal Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |