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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: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
| Official Title: | Phase III: The Study of Acid Reflux in Children With Asthma |
| Estimated Enrollment: | 300 |
| Study Start Date: | March 2007 |
| Estimated Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
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.
|
|
2: Placebo Comparator
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| Contact: Ellen Brown, MS | 410-955-3118 | ala-acrc@jhsph.edu |
| United States, Alabama | |
| University of Alabama at Birmingham | Completed |
| Birmingham, Alabama, United States, 35233 | |
| United States, California | |
| University of California San Diego | Recruiting |
| San Diego, California, United States, 92103 | |
| Contact: Tonya Tucker 617-471-0823 ttucker@ucsd.edu | |
| Principal Investigator: Stephen Wasserman, MD | |
| Sub-Investigator: Joe Ramsdell, MD | |
| United States, Colorado | |
| National Jewish Medical and Research Center | Recruiting |
| Denver, Colorado, United States, 80206 | |
| Contact: Holly O'Brien, RN 303-398-1966 o'brienh@njc.org | |
| Contact: Lisa H Lopez, LPN, CCRP 303-398-1233 lopezl@njc.org | |
| Principal Investigator: Rohit Katial, MD | |
| United States, Florida | |
| Nemours Children's Clinic | Recruiting |
| Jacksonville, Florida, United States, 32207 | |
| Contact: Melissa McRae, RN, MSN 904-697-2682 mmcrae@nemours.org | |
| Contact: Amber Santos, RN, MSN, MBA 904-858-3985 asantos@nemours.org | |
| Principal Investigator: John Lima, PharmD | |
| Sub-Investigator: Kathryn Blake, PharmD | |
| University of Miami School of Medicine | Recruiting |
| Miami, Florida, United States, 33613 | |
| Contact: Eliana Mendes, MD 305-243-2568 emendes@med.miami.edu | |
| Principal Investigator: Adam Wanner, MD | |
| University of South Florida College of Medicine | Recruiting |
| Tampa, Florida, United States, 33613 | |
| Contact: Shirley McCullough, BS 813-631-4024 smccullo@health.usf.edu | |
| Principal Investigator: Richard Lockey, MD, MS, BS | |
| Sub-Investigator: Monroe J. King, DO | |
| United States, Georgia | |
| Emory University School of Medicine | Completed |
| Atlanta, Georgia, United States, 30322 | |
| United States, Illinois | |
| Northwestern Memorial Hospital | Recruiting |
| Chicago, Illinois, United States, 60611 | |
| Contact: Jenny Hixon, BS 312-926-0975 j-franzen@northwestern.edu | |
| Principal Investigator: Lewis J. Smith, MD | |
| United States, Indiana | |
| Indiana University | Recruiting |
| Indianapolis, Indiana, United States, 46202 | |
| Contact: Paula Puntenney, RN, MA 317-274-1441 ppuntenn@iupui.edu | |
| Principal Investigator: Michael F. Busk, MD | |
| United States, Minnesota | |
| University of Minnesota | Completed |
| Minneapolis, Minnesota, United States, 55455 | |
| United States, Missouri | |
| University of Missouri, Kansas City School of Medicine | Recruiting |
| Kansas City, Missouri, United States, 64108 | |
| Contact: Patti Haney, RN, CCRC 816-404-5503 patti.haney@tmcmed.org | |
| Principal Investigator: Gary Salzman, MD | |
| Washington University School of Medicine | Recruiting |
| St. Louis, Missouri, United States, 63110 | |
| Contact: Jaime J. Tarsi, RN, MPH 314-747-3074 tarsij@wustl.edu | |
| Principal Investigator: Mario Castro, MD, MPH | |
| United States, New York | |
| New York University School of Medicine | Recruiting |
| New York, New York, United States, 10016 | |
| Contact: Karen Carpetyan, MA 212-263-2252 carapk01@med.nyu.edu | |
| Principal Investigator: Joan Reibman, MD | |
| New York Medical College | Recruiting |
| Valhalla, New York, United States, 10595 | |
| Contact: Ingrid Gherson, BS 914-594-3320 ingrid_gherson@nymc.edu | |
| Principal Investigator: Allen Dozor, MD | |
| North Shore-Long Island Jewish Health System | Recruiting |
| New Hyde Park, New York, United States, 11040 | |
| Contact: Ramona Ramdeo, MSN, FNP-C, RN, RRT 516-465-5461 rramdeo@lij.edu | |
| Principal Investigator: Jill Karpel, MD | |
| Sub-Investigator: Ruben Cohen, MD | |
| United States, North Carolina | |
| Duke University School of Medicine | Recruiting |
| Durham, North Carolina, United States, 27710 | |
| Contact: Catherine Foss, BS,RRT,RPFT 919-668-3599 foss0005@mc.duke.edu | |
| Contact: Denise Jaggers, RN 919-684-2689 denise.jaggers@duke.edu | |
| Principal Investigator: John Sundy, MD, PhD | |
| United States, Ohio | |
| Davis Heart and Lung Research Institute | Recruiting |
| Columbus, Ohio, United States, 43210 | |
| Contact: Sharon Cheung 614-366-2258 Sharon.Cheung@osumc.edu | |
| Contact: Valerie Barr 614-722-4750 Valerie.Barr@nationwide.childrens.org | |
| Principal Investigator: John Mastronarde, MD | |
| Sub-Investigator: Karen McCoy, MD | |
| United States, Pennsylvania | |
| Penn Presbyterain Medical Center/Penn Lung Center | Completed |
| Philadelphia, Pennsylvania, United States, 19104 | |
| United States, Texas | |
| Baylor College of Medicine | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Luz Giraldo, RRT, RPFT 713-798-2682 lgiraldo@bcm.tmc.edu | |
| Principal Investigator: Nicola Hanania, MD | |
| Sub-Investigator: Marianna Sockrider, MD, DrPH | |
| United States, Vermont | |
| Vermont Lung Center at The University of Vermont | Recruiting |
| Burlington, Vermont, United States, 05405 | |
| Contact: Stephanie Burns 802-847-2103 stephanie.burns@vtmednet.org | |
| Principal Investigator: Charles Irvin, PhD | |
| Sub-Investigator: Anne Dixon, MD | |
| 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: | Johns Hopkins University ( Janet Holbrook ) |
| Study ID Numbers: | 454, U01 HL080450-01 |
| Study First Received: | February 28, 2007 |
| Last Updated: | August 25, 2009 |
| ClinicalTrials.gov Identifier: | NCT00442013 History of Changes |
| Health Authority: | United States: Federal Government |
|
Anti-Infective Agents Molecular Mechanisms of Pharmacological Action Bronchial Diseases Immune System Diseases Gastrointestinal Agents Asthma Enzyme Inhibitors Pharmacologic Actions Lung Diseases, Obstructive |
Hypersensitivity Respiratory Tract Diseases Lung Diseases Therapeutic Uses Anti-Ulcer Agents Hypersensitivity, Immediate Lansoprazole Respiratory Hypersensitivity |