Study of Acid Reflux Therapy for Children With Asthma (SARCA)

This study has been completed.
Sponsor:
Collaborators:
American Lung Association
Johns Hopkins University
Nemours Children's Clinic
University of Manitoba
Washington University School of Medicine
New York Medical College
University of Vermont
Ohio State University
Baylor College of Medicine
Duke University
Information provided by (Responsible Party):
Anne M Fitzpatrick PhD, Emory University
ClinicalTrials.gov Identifier:
NCT00604851
First received: December 27, 2007
Last updated: January 14, 2014
Last verified: January 2014
  Purpose

Gastroesophageal reflux (GER) is frequent in children with asthma, can induce bronchspasm, and increase airway reactivity. Children with asthma are often treated for GER with drugs to supress gastric acid production. However, this treatment is expensive, and with unproven benefit. The primary objective of this study is to conduct a multi-site, randomized, clinical trial to test the hypothesis that treatment of GER with lansoprazole, an approved proton pump inhibitor, will decrease the frequency of exacerbations in children with poorly controlled asthma. The study will include 300 asthmatic children treated with inhaled corticosteroids, 6-16 years of age, with poor control defined by frequent symptoms, excessive beta agonist use, or frequent exacerbations. Participants will be randomly assigned to treatment with either lansoprazole or placebo for 6 months. The presence, severity, and relationship of GER to asthma symptoms will be determined with 24 hour esophageal pH monitoring, but randomization to treatment will not be influenced by the presence or severity of GER. The primary outcome measure is the proportion of participants who have exacerbations of asthma defined by diaries and interviews. Secondary outcome measures include asthma symptom and control scores, GER symptoms, lung function, and unscheduled health care contacts. Pre-defined subgroup analyses will examine the relationship between specific clinical features and the response to lansoprazole. Treatment response will also be evaluated with 3-hour post-dose plasma lansoprazole concentrations, and related to polymorphisms in the gene CYP2C19, the cytochrome P450 pathway, and interleukin-1 (IL-1) beta, a pro-inflammatory cytokine. Tertiary studies will determine how the magnitude of GER impacts airways inflammation, as measured by the concentrations of hydrogen ions (pH) and nitric oxide in expired breath. The results of this trial sould have a major impact on the understanding and treatment of GER in children with asthma.


Condition Intervention
Asthma
Drug: lansoprazole
Drug: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Study of Acid Reflux Therapy for Children With Asthma

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • Change in Asthma Control Questionnaire Score at the 24 Week Visit. [ Time Frame: Baseline and 24 weeks ] [ Designated as safety issue: No ]
    The Asthma Control Questionnaire contains 7 items that are scored on a 7 point scale (range is 0 to 6). The scores are then summed and divided by 7 to reveal an overall score. A lower score indicates better asthma control. The results reflect the difference in the Asthma Control Questionnaire Score between baseline (randomization visit) and 24 weeks of treatment.


Secondary Outcome Measures:
  • Asthma Symptom and Control Scores [ Time Frame: Baseline and 24 weeks ] [ Designated as safety issue: No ]
  • GER Symptoms [ Time Frame: Baseline and 24 weeks ] [ Designated as safety issue: No ]
  • Lung Function [ Time Frame: Baseline and 24 weeks ] [ Designated as safety issue: No ]
  • Unscheduled Heathcare Contacts [ Time Frame: Baseline and 24 weeks ] [ Designated as safety issue: No ]

Enrollment: 306
Study Start Date: September 2006
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lansoprazole
Participants <30 kg: 15 mg by mouth once daily; participants >= 30 kg: 30 mg by mouth once daily
Drug: lansoprazole
participants < 30 kg: 15 mg by mouth once daily; participants >= 30 kg: 30 mg by mouth once daily
Other Name: brand name Prevacid
Placebo Comparator: Placebo
Placebo medication taken by mouth once daily
Drug: placebo
placebo medication taken by mouth once daily
Other Name: No brand names

  Eligibility

Ages Eligible for Study:   6 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:Age:

  • 6-16 years
  • Asthma: Physician diagnosed asthma, mathacholine PC20<16 mg/ml, treatment with a stable dose of daily inhaled corticosteroid equivalent to 200 micrograms/day of fluticasone or greater for 8 weeks or longer
  • Poor asthma control: Use of beta-agonist for asthma symptoms twice/week or more, nocturnal awakening with asthma symptoms more than once per week, 2 or more emergency department, unscheduled physician visit, prednisone course, or hospitalizations for asthma in the past 12 months, Score of 1.5 or greater on the Juniper Scale of Recent Asthma Control
  • Absence of GERD symptoms: No symptoms clearly attributed to GER at the time of enrollment.

Exclusion Criteria:

  • Surgery: Previous anti-reflux or peptic ulcer surgery, previous tracheo-esophageal fistula repair
  • Pulmonary Function:FEV1 <60% predicted normal as measured immediately before methacholine bronchoprovocation. Methacholine bronchoprovocation limited to participants with an FEV1 >70% of predicted in accordance with FDA indication
  • Other major chronic illnesses: 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, renal failure, liver disorders, immunodeficiency states, significant neurodevelopmental delay or behavioral disorders or other conditions that would interfere with participation in the study.
  • Medication Use: Anti-reflux medication (proton pump inhibitors, H2 blockers, bethanecol, metaclopromide) within 1 month; Theophylline preparations, azoles, anti-coagulants, insulin, digitalis, any investigative drug within 2 months.
  • Drug allergy: Previous adverse effects from lansoprazole, other proton pump inhibitors or methacholine challenge.
  • Non-adherence: Inability or unwillingness of the legal guardian to provide consent or inability or unwillingness of the child to provide assent. Inability to swallow study medication. Inability to perform baseline measurements. Less than 80% completion of screening period diaries. Inability to contact by telephone. Intention to move out of the areqa within 6 months. No pregnancy.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00604851

Locations
United States, Georgia
Emory Childrens Center
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
American Lung Association
Johns Hopkins University
Nemours Children's Clinic
University of Manitoba
Washington University School of Medicine
New York Medical College
University of Vermont
Ohio State University
Baylor College of Medicine
Duke University
Investigators
Principal Investigator: William G Teague, MD Emory University
  More Information

No publications provided by Emory University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Anne M Fitzpatrick PhD, Assistant Professor, Emory University
ClinicalTrials.gov Identifier: NCT00604851     History of Changes
Other Study ID Numbers: IRB00001316, 5U01HL080433-02, SARCA
Study First Received: December 27, 2007
Results First Received: July 10, 2013
Last Updated: January 14, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Lansoprazole
Dexlansoprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 19, 2014