Lansoprazole to Treat Children With Asthma (SARCA)

This study has been completed.
Sponsor:
Collaborators:
American Lung Association Asthma Clinical Research Centers
Information provided by (Responsible Party):
Janet Holbrook, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00442013
First received: February 28, 2007
Last updated: December 5, 2012
Last verified: December 2012
  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: Matching placebo
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Change in Juniper Asthma Control Score (ACS) [ Time Frame: Measured at Weeks 0, 4, 8, 12, 24 ] [ Designated as safety issue: No ]
    Score ranges from 0 to 6, a lower score indicated better asthma control. Scores above 1.5 are indicative of poor asthma control; score obtained from questionnaire with 6 questions related to asthma control and FEV (amount of air expired in the first second during a forced expiratory maneuver); number presents an average of the change from baseline to all follow-up points


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 ]
    Scores range from 1 to 7 with higher values indicating better asthma-related quality of life; questionnaire measures functional impairments that are most troublesome to children as a result of their asthma; number presents an average of the change from baseline to all follow-up points

  • Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) [ Time Frame: Measured at Weeks 0, 4, 8, 12, 16, 20, 24 ] [ Designated as safety issue: No ]
    A measure of pulmonary function, specifically the amount of expired air in the first second during a forced expiratory maneuver while seated; test performed at least 4 hours after last dose of short-acting bronchodilator and at least 12 hours after long-acting bronchodilator; number presents an average of the change from baseline to all follow-up points

  • Rate of Episodes of Poor Asthma Control (EPAC) [ Time Frame: Measured daily for 24 weeks by diary ] [ Designated as safety issue: No ]

    Episodes of poor asthma control are defined as any one of the following:

    • 2 consecutive days with peak flow at less than 70% of baseline
    • prescription of oral corticosteroids for asthma
    • seeking urgent medical care for asthma symptoms

    EPAC was measured by review of daily diaries that were maintained over the entire course of followup, i.e, 24 weeks


  • Asthma Symptom Utility Index (ASUI) [ Time Frame: Measured at Weeks 0, 4, 8, 12, 16, 20, 24 ] [ Designated as safety issue: No ]
    ASUI is a utility score that ranges from 0 to 1, with higher values indicating better asthma control; info obtained from questionnaire about asthma symptoms; number presents an average of the change from baseline to all follow-up points

  • Airways Reactivity (Assessed by Methacholine PC20) [ Time Frame: Measured at Weeks 0 and 24 ] [ Designated as safety issue: No ]
    Presence and degree of airway hyperresponsiveness; change from baseline to 24 weeks for airways reactivity assessed by methacholine post-diluent baseline (PC20) after medication holds


Enrollment: 306
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: Lansoprazole
Participants in this group will receive lansoprazole on a daily basis for 6 months. There are two doses of Lansoprazole solutab provided to participants depending on participant body weight at randomization: 1.) less than 30kg will receive 15mg po once daily or 2.)greater or equal to 30kg 30mg po once daily.
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: Matching placebo
Participants in this group will receive a matching placebo on a daily basis for 6 months. To maintain masking, there are two doses of the matching placebo provided to participants depending on participant body weight at randomization: 1.) less than 30kg will receive 15mg po once daily or 2.)greater or equal to 30kg 30mg po once daily.
Drug: Matching placebo
Participants will receive a placebo pill on a daily basis. To maintain masking, there are two doses of the matching placebo provided to participants depending on participant body weight at randomization: 1.) less than 30kg will receive 15mg po once daily or 2.)greater or equal to 30kg 30mg po once daily.
Other Name: Matching placebo manufactured by TAP Pharmaceuticals

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 potential Hydrogen (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 amount of air expired in first second during a forced expiratory maneuver (FEV1) post-bronchodilator, or
    2. Methacholine post-diluent baseline (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 Asthma Control Score (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 tracheoesophageal 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

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
Sponsors and Collaborators
Johns Hopkins University
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

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Janet Holbrook, Associate Professor, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00442013     History of Changes
Other Study ID Numbers: 454, U01HL080450-01
Study First Received: February 28, 2007
Results First Received: July 23, 2012
Last Updated: December 5, 2012
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on April 20, 2014