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

December 27, 2007
January 14, 2014
September 2006
December 2011   (final data collection date for primary outcome measure)
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.
The proportion of participants who have exacerbations of asthma as defined by diaries and interviews. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00604851 on ClinicalTrials.gov Archive Site
  • 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 ]
  • asthma symptom and control scores [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • GER symptoms [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • lung function [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • unscheduled heathcare contacts [ Time Frame: within 6 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Study of Acid Reflux Therapy for Children With Asthma
Study of Acid Reflux Therapy for Children With Asthma

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Asthma
  • 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
  • Drug: placebo
    placebo medication taken by mouth once daily
    Other Name: No brand names
  • Experimental: Lansoprazole
    Participants <30 kg: 15 mg by mouth once daily; participants >= 30 kg: 30 mg by mouth once daily
    Intervention: Drug: lansoprazole
  • Placebo Comparator: Placebo
    Placebo medication taken by mouth once daily
    Intervention: Drug: placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
306
December 2011
December 2011   (final data collection date for primary outcome measure)

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.
Both
6 Years to 16 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00604851
IRB00001316, 5U01HL080433-02, SARCA
Yes
Anne M Fitzpatrick PhD, Emory University
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
  • National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: William G Teague, MD Emory University
Emory University
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP