Study of Acid Reflux in Asthma
Condition: Asthma; Lung Diseases; Lung Diseases, Obstructive
MeSH terms: Asthma; Lung Diseases; Lung Diseases, Obstructive
Intervention: Esomeprazole; Placebo proton pump inhibitor
Intervention description: Proton pump inhibitor 40 mg orally twice daily; Placebo proton pump inhibitor
Intervention MeSH terms: Esomeprazole; Proton Pump Inhibitors
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 403.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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

        Exclusion Criteria:

          -  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