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AsthmaPhase 4SARCANCT00442013

Lansoprazole to Treat Children With Asthma

A Phase 4 study testing Lansoprazole in people with Asthma, run by Johns Hopkins University at 20 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 6 to 17 years
Conditions the study is for
Asthma
What is being tested?
Lansoprazole
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
306 participants
Where
20 sitesUnited States
Study dates
Mar 2007to Aug 2011
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Physician-diagnosed asthma
  • At least one of the following lung function criteria must be documented in the year prior to study entry:
  • 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
  • Methacholine post-diluent baseline (PC20) less than 16 mg/ml, or
  • 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)
Show all 12Show fewer
  • Poor asthma control as defined by any one of the following criteria:
  • Use of beta-agonist for asthma symptoms twice a week or more on average in the month prior to study entry
  • Nocturnal awakening with asthma symptoms more than once per week on average in the month prior to study entry
  • Two or more emergency department visits, unscheduled physician visits, prednisone courses, or hospitalizations for asthma in the 12 months prior to study entry
  • 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

Who cannot join

  • 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
Show all 18Show fewer
  • 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

Trial locations and contacts

20 sites in 1 country.

20 sites in 1 country

United States20 sites

  • Emory University School of Medicine

    Atlanta, Georgia, 30322

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35233

  • Vermont Lung Center at The University of Vermont

    Burlington, Vermont, 05405

  • Northwestern Memorial Hospital

    Chicago, Illinois, 60611

  • Davis Heart and Lung Research Institute

    Columbus, Ohio, 43210

  • National Jewish Medical and Research Center

    Denver, Colorado, 80206

  • Duke University School of Medicine

    Durham, North Carolina, 27710

  • Baylor College of Medicine

    Houston, Texas, 77030

  • Indiana University

    Indianapolis, Indiana, 46202

  • Nemours Children's Clinic

    Jacksonville, Florida, 32207

  • University of Missouri, Kansas City School of Medicine

    Kansas City, Missouri, 64108

  • University of Miami School of Medicine

    Miami, Florida, 33613

  • University of Minnesota

    Minneapolis, Minnesota, 55455

  • North Shore-Long Island Jewish Health System

    New Hyde Park, New York, 11040

  • New York University School of Medicine

    New York, New York, 10016

  • Penn Presbyterain Medical Center/Penn Lung Center

    Philadelphia, Pennsylvania, 19104

  • University of California San Diego

    San Diego, California, 92103

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • University of South Florida College of Medicine

    Tampa, Florida, 33613

  • New York Medical College

    Valhalla, New York, 10595

Other trials in United States

About this study

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

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.

Read the 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.

Conditions
Asthma
Being tested
Lansoprazole, Matching placebo
Medical subject headings
Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LansoprazoleDrug

    Also called Prevacid

    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.

  • Matching placeboDrug

    Also called Matching placebo manufactured by TAP Pharmaceuticals

    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.

Study groups in NCT00442013
Study groupRoleWhat they receive
LansoprazoleExperimentalParticipants 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.
Receives: Drug: Lansoprazole
Matching placeboPlacebo comparatorParticipants 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.
Receives: Drug: Matching placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Juniper Asthma Control Score (ACS)

    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

    Measured: Measured at Weeks 0, 4, 8, 12, 24

Secondary outcomes (5)

  1. Asthma-specific Quality of Life

    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

    Measured: Measured at Weeks 0, 4, 8, 12, 16, 20, 24

  2. Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1)

    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

    Measured: Measured at Weeks 0, 4, 8, 12, 16, 20, 24

  3. Rate of Episodes of Poor Asthma Control (EPAC)

    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

    Measured: Measured daily for 24 weeks by diary

  4. Asthma Symptom Utility Index (ASUI)

    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

    Measured: Measured at Weeks 0, 4, 8, 12, 16, 20, 24

  5. Airways Reactivity (Assessed by Methacholine PC20)

    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

    Measured: Measured at Weeks 0 and 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Mar 2007 (estimated)
  2. Study startMar 2007
  3. Primary completionApr 2011
  4. Study completionAug 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
306 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00442013
Sponsor's protocol ID
454
Other IDs
U01HL080450-01
Acronym
SARCA
Status last verified
Dec 2012
First submitted
28 Feb 2007
Last updated
6 Dec 2012
Data monitoring committee
Yes

Publications

  • Writing Committee for the American Lung Association Asthma Clinical Research Centers; Holbrook JT, Wise RA, Gold BD, Blake K, Brown ED, Castro M, Dozor AJ, Lima JJ, Mastronarde JG, Sockrider MM, Teague WG. Lansoprazole for children with poorly controlled asthma: a randomized controlled trial. JAMA. 2012 Jan 25;307(4):373-81. doi: 10.1001/jama.2011.2035.

    PubMed 22274684

  • Kaminsky DA, He J, Henderson R, Dixon AE, Irvin CG, Mastronarde J, Smith LJ, Sugar EA, Wise RA, Holbrook JT. Bronchodilator response does not associate with asthma control or symptom burden among patients with poorly controlled asthma. Respir Med. 2023 Nov;218:107375. doi: 10.1016/j.rmed.2023.107375. Epub 2023 Aug 1.

    PubMed 37536444

  • Lang JE, Holbrook JT, Mougey EB, Wei CY, Wise RA, Teague WG, Lima JJ; American Lung Association-Airways Clinical Research Centers. Lansoprazole Is Associated with Worsening Asthma Control in Children with the CYP2C19 Poor Metabolizer Phenotype. Ann Am Thorac Soc. 2015 Jun;12(6):878-85. doi: 10.1513/AnnalsATS.201408-391OC.

    PubMed 25844821

  • Fitzpatrick AM, Holbrook JT, Wei CY, Brown MS, Wise RA, Teague WG; American Lung Association's Asthma Clinical Research Centers Network. Exhaled breath condensate pH does not discriminate asymptomatic gastroesophageal reflux or the response to lansoprazole treatment in children with poorly controlled asthma. J Allergy Clin Immunol Pract. 2014 Sep-Oct;2(5):579-86.e7. doi: 10.1016/j.jaip.2014.04.006. Epub 2014 May 21.

    PubMed 25213052

  • Nguyen JM, Holbrook JT, Wei CY, Gerald LB, Teague WG, Wise RA; American Lung Association Asthma Clinical Research Centers. Validation and psychometric properties of the Asthma Control Questionnaire among children. J Allergy Clin Immunol. 2014 Jan;133(1):91-7.e1-6. doi: 10.1016/j.jaci.2013.06.029. Epub 2013 Aug 6.

    PubMed 23932458

  • Lima JJ, Lang JE, Mougey EB, Blake KB, Gong Y, Holbrook JT, Wise RA, Teague WG. Association of CYP2C19 polymorphisms and lansoprazole-associated respiratory adverse effects in children. J Pediatr. 2013 Sep;163(3):686-91. doi: 10.1016/j.jpeds.2013.03.017. Epub 2013 Apr 24.

    PubMed 23623526

  • Mougey E, Lang JE, Allayee H, Teague WG, Dozor AJ, Wise RA, Lima JJ. ALOX5 polymorphism associates with increased leukotriene production and reduced lung function and asthma control in children with poorly controlled asthma. Clin Exp Allergy. 2013 May;43(5):512-20. doi: 10.1111/cea.12076.

    PubMed 23600541

  • Blake K, Teague WG. Gastroesophageal reflux disease and childhood asthma. Curr Opin Pulm Med. 2013 Jan;19(1):24-9. doi: 10.1097/MCP.0b013e32835b582b.

    PubMed 23197288

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Lansoprazole in people with Asthma, run by Johns Hopkins University at 20 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Dec 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Juniper Asthma Control Score (ACS) (time frame: Measured at Weeks 0, 4, 8, 12, 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00442013, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2012.

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