Lansoprazole to Treat Children With Asthma

Condition(s) targeted: Asthma

Intervention: Lansoprazole (Drug); Placebo (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: National Heart, Lung, and Blood Institute (NHLBI)

Official(s) and/or principal investigator(s):
Janet Holbrook, PhD, MPH, Principal Investigator, Affiliation: Johns Hopkins University School of Public Health
Gerald Teague, MD, Principal Investigator, Affiliation: University of Virginia

Overall contact:
Ellen Brown, MS, Phone: 410-955-3118, Email: ala-acrc@jhsph.edu

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.

Official title: Phase III: The Study of Acid Reflux in Children With Asthma

Study design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

Primary outcome: Change in Juniper Asthma Control Score (ACS)

Secondary outcome:

Asthma-specific quality of life

Lung function measures (assessed by spirometry)

Rate of episodes of poor asthma control (EPAC)

Asthma symptom utility index

Airways reactivity (assessed by methacholine PC20)

Detailed description: 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.

Minimum age: 6 Years. Maximum age: 17 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Physician-diagnosed asthma

- At least one of the following lung function criteria must be documented in the year

prior to study entry:

1. Bronchial hyperresponsiveness confirmed by 12% or greater improvement in FEV1 post-bronchodilator, or

2. Methacholine PC20 less than 16 mg/ml, or

3. Exercise bronchoprovocation test with at least a 20% decrease in FEV1

- Currently on stable dose of daily inhaled corticosteroid for asthma control (i. e.,

inhaled corticosteroid equivalent to 2 puffs of 44 ug twice per day [176 ug] of fluticasone or greater for 8 weeks or longer prior to study entry)

- Poor asthma control as defined by any one of the following criteria:

1. Use of beta-agonist for asthma symptoms twice a week or more on average in the month prior to study entry

2. Nocturnal awakening with asthma symptoms more than once per week on average in the month prior to study entry

3. Two or more emergency department visits, unscheduled physician visits, prednisone courses, or hospitalizations for asthma in the 12 months prior to study entry

4. Juniper ACS of 1. 25 or greater at the first screening visit

- Absence of GERD symptoms at the time of study entry

Exclusion Criteria:

- Previous anti-reflux or peptic ulcer surgery

- Previous tracheo-esophageal fistula repair

- FEV1 less than 60% of predicted normal value at screening visit and as measured

immediately before methacholine bronchoprovocation; methacholine bronchoprovocation will be limited to participants with a FEV1 greater than or equal to 70% of predicted value in accordance with American Thoracic Society (ATS) guidelines

- History of a premature birth of less than 33 weeks gestation or any neonate requiring

a significant level of respiratory care, including mechanical ventilation

- Any major chronic illness, including but not limited to non-skin cancer, cystic

fibrosis, bronchiectasis, myelomeningocele, sickle cell anemia, endocrine disease, congenital heart disease, congestive heart failure, stroke, severe hypertension, insulin-dependent diabetes mellitus, kidney failure, liver disorder, immunodeficiency state, significant neuro-developmental delay or behavioral disorder (excluding mild attention deficit hyperactivity disorder), or other condition that would interfere with participation in the study

- History of phenylketonuria

- Medications for treatment of GI symptoms (e. g., proton pump inhibitors, H2 blockers,

bethanechol, metoclopramide) in the month prior to study entry (intermittent anti-acids are allowed)

- Use of theophylline preparations, azoles, anti-coagulants, insulin for Type I

diabetes, digitalis, or oral iron supplements when administered for iron deficiency in the month prior to study entry

- Use of any investigative drug in the 2 months prior to study entry

- Previous adverse effects from lansoprazole, other proton pump inhibitors, or

sensitivity to aspartame

- Inability or unwillingness of the legal guardian to provide consent

- Inability or unwillingness of the child to provide assent

- Inability to take study medication

- Inability to perform baseline measurements

- Less than 80% completion of screening period diaries

- Inability to contact by telephone

- Planning to move out of the area in the 6 months following study entry

- Pregnancy

Ellen Brown, MS, Phone: 410-955-3118, Email: ala-acrc@jhsph.edu

University of Alabama at Birmingham, Birmingham, Alabama 35233, United States; Completed

University of California San Diego, San Diego, California 92103, United States; Recruiting
Tonya Tucker, Phone: 617-471-0823, Email: ttucker@ucsd.edu
Stephen Wasserman, MD, Principal Investigator
Joe Ramsdell, MD, Sub-Investigator

National Jewish Medical and Research Center, Denver, Colorado 80206, United States; Recruiting
Holly O'Brien, RN, Phone: 303-398-1966, Email: o'brienh@njc.org
Lisa H Lopez, LPN, CCRP, Phone: 303-398-1233, Email: lopezl@njc.org
Rohit Katial, MD, Principal Investigator

Nemours Children's Clinic, Jacksonville, Florida 32207, United States; Recruiting
Melissa McRae, RN, MSN, Phone: 904-697-2682, Email: mmcrae@nemours.org
Amber Santos, RN, MSN, MBA, Phone: 904-858-3985, Email: asantos@nemours.org
John Lima, PharmD, Principal Investigator
Kathryn Blake, PharmD, Sub-Investigator

University of Miami School of Medicine, Miami, Florida 33613, United States; Recruiting
Eliana Mendes, MD, Phone: 305-243-2568, Email: emendes@med.miami.edu
Adam Wanner, MD, Principal Investigator

University of South Florida College of Medicine, Tampa, Florida 33613, United States; Recruiting
Shirley McCullough, BS, Phone: 813-631-4024, Email: smccullo@health.usf.edu
Richard Lockey, MD, MS, BS, Principal Investigator
Monroe J. King, DO, Sub-Investigator

Emory University School of Medicine, Atlanta, Georgia 30322, United States; Completed

Northwestern Memorial Hospital, Chicago, Illinois 60611, United States; Recruiting
Jenny Hixon, BS, Phone: 312-926-0975, Email: j-franzen@northwestern.edu
Lewis J. Smith, MD, Principal Investigator

Indiana University, Indianapolis, Indiana 46202, United States; Recruiting
Paula Puntenney, RN, MA, Phone: 317-274-1441, Email: ppuntenn@iupui.edu
Michael F. Busk, MD, Principal Investigator

University of Minnesota, Minneapolis, Minnesota 55455, United States; Completed

University of Missouri, Kansas City School of Medicine, Kansas City, Missouri 64108, United States; Recruiting
Patti Haney, RN, CCRC, Phone: 816-404-5503, Email: patti.haney@tmcmed.org
Gary Salzman, MD, Principal Investigator

Washington University School of Medicine, St. Louis, Missouri 63110, United States; Recruiting
Jaime J. Tarsi, RN, MPH, Phone: 314-747-3074, Email: tarsij@wustl.edu
Mario Castro, MD, MPH, Principal Investigator

New York University School of Medicine, New York, New York 10016, United States; Recruiting
Karen Carpetyan, MA, Phone: 212-263-2252, Email: carapk01@med.nyu.edu
Joan Reibman, MD, Principal Investigator

New York Medical College, Valhalla, New York 10595, United States; Recruiting
Ingrid Gherson, BS, Phone: 914-594-3320, Email: ingrid_gherson@nymc.edu
Allen Dozor, MD, Principal Investigator

North Shore-Long Island Jewish Health System, New Hyde Park, New York 11040, United States; Recruiting
Ramona Ramdeo, MSN, FNP-C, RN, RRT, Phone: 516-465-5461, Email: rramdeo@lij.edu
Jill Karpel, MD, Principal Investigator
Ruben Cohen, MD, Sub-Investigator

Duke University School of Medicine, Durham, North Carolina 27710, United States; Recruiting
Catherine Foss, BS,RRT,RPFT, Phone: 919-668-3599, Email: foss0005@mc.duke.edu
Denise Jaggers, RN, Phone: 919-684-2689, Email: denise.jaggers@duke.edu
John Sundy, MD, PhD, Principal Investigator

Davis Heart and Lung Research Institute, Columbus, Ohio 43210, United States; Recruiting
Sharon Cheung, Phone: 614-366-2258, Email: Sharon.Cheung@osumc.edu
Valerie Barr, Phone: 614-722-4750, Email: Valerie.Barr@nationwide.childrens.org
John Mastronarde, MD, Principal Investigator
Karen McCoy, MD, Sub-Investigator

Penn Presbyterain Medical Center/Penn Lung Center, Philadelphia, Pennsylvania 19104, United States; Completed

Baylor College of Medicine, Houston, Texas 77030, United States; Recruiting
Luz Giraldo, RRT, RPFT, Phone: 713-798-2682, Email: lgiraldo@bcm.tmc.edu
Nicola Hanania, MD, Principal Investigator
Marianna Sockrider, MD, DrPH, Sub-Investigator

Vermont Lung Center at The University of Vermont, Burlington, Vermont 05405, United States; Recruiting
Stephanie Burns, Phone: 802-847-2103, Email: stephanie.burns@vtmednet.org
Charles Irvin, PhD, Principal Investigator
Anne Dixon, MD, Sub-Investigator

Starting date: March 2007
Last updated: August 25, 2009