Study of Acid Reflux in Asthma

Completed · Phase 3 · Has a placebo group

Conditions studied: Asthma, Lung Diseases, Lung Diseases, Obstructive

In brief

The purpose of this study is to determine if subjects with symptomatic asthma who are assigned to treatment with a proton pump inhibitor (PPI) drug such as Nexium have fewer asthma attacks than similar subjects assigned to placebo treatment.

Key facts

Study ID

NCT00069823

Run by

Johns Hopkins Bloomberg School of Public Health

People needed

403

Starts

2003-09-01

Expected to finish

2008-05-01

Last updated by the study team

2012-12-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• The general goal of patient selection is to enroll patients for whom asthma physicians might prescribe GERD treatment, but where there is uncertainty whether it might be effective.
• Age 18 or older
• Physician diagnosed asthma
• If amount of air expired in the first second during a forced expiratory maneuver (FEV1) is greater than or equal to 70% predicted normal pre-bronchodilator: demonstrate methacholine 20% from post-diluent baseline (PC20). PC20 less than 16 mg/ml during Visit 1
• If FEV1 less than 70% and greater than or equal to 50% predicted normal pre-bronchodilator: demonstrate 12% reversibility during Visit 1 or within past 12 months
• Currently on stable dose of daily inhaled steroids for asthma control, i.e., inhaled corticosteroid equivalent to 400 ug/day of fluticasone44 or greater for 8 weeks or longer
• Poor asthma control: Either of the following; a score of 1.5 or greater on the Juniper Asthma Control Questionnaire; two or more episodes of asthma symptoms in the past 12 months with each episode requiring at least one of the following: an emergency department visit, unscheduled physician visit, prednisone course, hospitalization
• Non-smoker for 6 months or longer
• Less than 10 pack/year smoking history

You may not qualify if…

• Surgery: Previous anti-reflux or peptic ulcer surgery
• Pulmonary function: FEV1 less than 50% predicted normal pre-bronchodilator
• GERD Symptoms: Severe reflux constituting a clinical indication for treatment with a PPI or H2 blocker, typically two or more episodes per week of heartburn requiring antacids
• Other major chronic illnesses; conditions which in the judgment of the Study Physician would interfere with participation in the study, e.g., non-skin cancer, endocrine disease, coronary artery disease, congestive heart failure, stroke, severe hypertension, Type 1 insulin dependent diabetes mellitus, renal failure, liver disorders, immunodeficiency states, major neuropsychiatric disorder
• Medication use: Anti-reflux medication (proton pump inhibitors or H2 blockers) within 1 month Theophylline, azoles, iron, anti-coagulants, insulin (for Type I diabetes), digitalis, any investigative drugs within 1 month
• Drug allergy: Previous adverse effects from proton pump inhibitors or methacholine challenge
• Females of childbearing potential: Pregnant or lactating, unwilling to practice an adequate birth control method (abstinence, combination barrier and spermicide, or hormonal)
• Inability or unwillingness to provide consent
• Inability to perform baseline measurements
• Completion of less than 10 of the last 14 days of screening period diary entry
• Inability to be contacted by telephone
• Intention to move out of the area within 6 months

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• University of California, San Diego — San Diego, California, United States
• National Jewish Medical and Research Center — Denver, Colorado, United States
• Nemours Childrens Clinic — Jacksonville, Florida, United States
• University of Miami — Miami, Florida, United States
• Emory University — Atlanta, Georgia, United States
• Northwestern Memorial Hospital — Chicago, Illinois, United States
• Indiana University ACRC — Indianapolis, Indiana, United States
• LSUHSC Pulmonary Critical Care — New Orleans, Louisiana, United States
• University of Minnesota — Minneapolis, Minnesota, United States
• Univ of MO Kansas City School of Medicine — Kansas City, Missouri, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• North Shore-LIJ Medical Center — New Hyde Park, New York, United States
• NYU School of Medicine — New York, New York, United States
• New York Medical College — Valhalla, New York, United States
• Duke University — Durham, North Carolina, United States
• Ohio State University — Columbus, Ohio, United States
• Thomas Jefferson Hospital Pulmonary Lab — Philadelphia, Pennsylvania, United States
• Baylor College of Medicine — Houston, Texas, United States
• Northern New England Consortium — Colchester, Vermont, United States

Full record on ClinicalTrials.gov

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