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Lansoprazole to Treat Children With Asthma (SARCA)
This study is currently recruiting participants.
Verified by National Heart, Lung, and Blood Institute (NHLBI), August 2009
First Received: February 28, 2007   Last Updated: August 25, 2009   History of Changes
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

Resource links provided by NLM:


Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Primary Outcome Measures:
  • Change in Juniper Asthma Control Score (ACS) [ Time Frame: Measured at Weeks 0, 4, 8, 12, 16, 20, 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Asthma-specific quality of life [ Time Frame: Measured at Weeks 0, 4, 8, 12, 16, 20, 24 ] [ Designated as safety issue: No ]
  • Lung function measures (assessed by spirometry) [ Time Frame: Measured at Weeks 0, 4, 8, 12, 16, 20, 24 ] [ Designated as safety issue: No ]
  • Rate of episodes of poor asthma control (EPAC) [ Time Frame: Measured daily by diary ] [ Designated as safety issue: No ]
  • Asthma symptom utility index [ Time Frame: Measured at Weeks 0, 4, 8, 12, 16, 20, 24 ] [ Designated as safety issue: No ]
  • Airways reactivity (assessed by methacholine PC20) [ Time Frame: Measured at Weeks 0 and 24 ] [ Designated as safety issue: No ]

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.

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.

  Eligibility

Ages Eligible for Study:   6 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00442013

Contacts
Contact: Ellen Brown, MS 410-955-3118 ala-acrc@jhsph.edu

Locations
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            
Sponsors and Collaborators
American Lung Association Asthma Clinical Research Centers
Investigators
Principal Investigator: Janet Holbrook, PhD, MPH Johns Hopkins University School of Public Health
Principal Investigator: Gerald Teague, MD University of Virginia
  More Information

No publications provided

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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on February 08, 2010