Clinical trial NCT00069823 (phase 3, status: completed)
Conditions: asthma, lung diseases, lung diseases, obstructive
ICD codes: J45.998, J82.83, J45.909, J45.991, J45.20, J45.30, J45.40, J84.115, M05.10, M05.111, M05.112, M05.119, M05.121, M05.122, G91.1, I42.1, N11.1, J05.0, G47.33, J44.9, N13.8
Drugs: esomeprazole, placebo proton pump inhibitor
SMILES: COC1=CC2=C(NC(=N2)[S@@](=O)CC2=NC=C(C)C(OC)=C2C)C=C1, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
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