Lansoprazole to Treat Children With Asthma

Asthma Clinical Trial

— SARCA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00442013
• Other study ID #: 454
• Secondary ID: U01HL080450-01
• Status: Completed
• Phase: Phase 4
• First received: February 28, 2007
• Last updated: December 5, 2012
• Start date: March 2007
• Est. completion date: August 2011

Study information

• Verified date: December 2012
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical 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 children with poorly controlled asthma.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 306
• Est. completion date: August 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 17 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Emory University School of Medicine	Atlanta	Georgia
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Vermont Lung Center at The University of Vermont	Burlington	Vermont
United States	Northwestern Memorial Hospital	Chicago	Illinois
United States	Davis Heart and Lung Research Institute	Columbus	Ohio
United States	National Jewish Medical and Research Center	Denver	Colorado
United States	Duke University School of Medicine	Durham	North Carolina
United States	Baylor College of Medicine	Houston	Texas
United States	Indiana University	Indianapolis	Indiana
United States	Nemours Children's Clinic	Jacksonville	Florida
United States	University of Missouri, Kansas City School of Medicine	Kansas City	Missouri
United States	University of Miami School of Medicine	Miami	Florida
United States	University of Minnesota	Minneapolis	Minnesota
United States	North Shore-Long Island Jewish Health System	New Hyde Park	New York
United States	New York University School of Medicine	New York	New York
United States	Penn Presbyterain Medical Center/Penn Lung Center	Philadelphia	Pennsylvania
United States	University of California San Diego	San Diego	California
United States	Washington University School of Medicine	St. Louis	Missouri
United States	University of South Florida College of Medicine	Tampa	Florida
United States	New York Medical College	Valhalla	New York

Sponsors (3)

Lead Sponsor	Collaborator
Johns Hopkins University	American Lung Association Asthma Clinical Research Centers, National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 at Weeks 0, 4, 8, 12, 24	No
Secondary	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 at Weeks 0, 4, 8, 12, 16, 20, 24	No
Secondary	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 at Weeks 0, 4, 8, 12, 16, 20, 24	No
Secondary	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 daily for 24 weeks by diary	No
Secondary	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 at Weeks 0, 4, 8, 12, 16, 20, 24	No
Secondary	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 at Weeks 0 and 24	No