MethaCholine Bronchoprovocation Study (MeCIS)
Condition: Asthma
MeSH terms: Asthma
Intervention: fluticasone
Intervention description: Inhaled corticosteroid approved for treatment of asthma
Intervention MeSH terms: Fluticasone
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 219.0
Sex: All
Minimum age: 12 Years
Maximum age: 69 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Normal Controls

Summary:

      The purpose of this research is to evaluate the methacholine challenge test as an accurate
      indicator of asthma in patients receiving treatment for asthma. Phase 1 on the study compares
      methacholine challenge test results from asthma patients to those from people who do not have
      asthma. In phase 2, test results for people with asthma on low dose inhaled corticosteroid
      will be compared to results on high dose inhaled corticosteroids. Both males and females with
      stable asthma (asthma participants) and without asthma (controls) enrolled. Participants will
      be between 12 and 69 years of age.
    

Eligibility criteria:

        Asthmatic participants

        Inclusion Criteria:

          -  Males or females greater than or equal to 12 and less than 70 years of age

          -  Physician-diagnosed and investigator-confirmed stable asthma (excluding exercise
             induced asthma)

          -  Current treatment for asthma by a healthcare provider within the preceding twelve
             months: current asthma treatment defined as regular use of asthma medications. Asthma
             medications include short and long acting adrenergic bronchodilators, bronchodilator
             combinations, inhaled anticholinergics, inhaled corticosteroids, cromolyn sodium and
             nedocromil, leukotriene modifiers and methylxanthines

          -  Stable asthma defined by no asthma exacerbation (emergency room visit,
             hospitalization, course of increased systemic steroids, or urgent health care visit
             for asthma) during the prior four weeks

          -  Forced expiratory volume at one second (FEV1) >70% predicted pre-bronchodilator

          -  Ability to provide screening and baseline information

          -  Ability and willingness to provide informed consent

          -  For women of childbearing potential: not pregnant, non-lactating, and agree to
             practice an adequate birth control method (abstinence, combination barrier and
             spermicide, or hormonal) for the duration of the study

        Exclusion Criteria:

          -  Chronic oral steroid therapy (daily)

          -  Oral corticosteroid use within past 4 weeks

          -  Respiratory tract infection within past 4 weeks

          -  Chronic diseases (other than asthma) that in the opinion of the investigator would
             prevent participation in the trial or put the participant at risk by participation,
             e.g. chronic diseases of the lung (other than asthma), heart, liver, kidney, or
             nervous system, or immunodeficiency

          -  Known allergy to methacholine (for example, a previous bad reaction to methacholine)
             or to any other parasympathomimetic agents

          -  Current use of beta adrenergic blocking agent (a heart medicine) or a cholinesterase
             inhibitor (medicine used to treat myasthenia gravis or Alzheimer's disease).

          -  History of epilepsy, cardiovascular disease with bradycardia (slow heart beat),
             vagotonia (increased activity of the vagus nerve causing slow heart rate or low blood
             pressure), peptic ulcer disease, thyroid disease, or urinary tract obstruction

          -  History of cigarette smoking within the past 5 years or >10 pack years total

          -  Use of investigative drugs or intervention trials in the 30 days prior to enrollment
             or during the duration of the study

          -  Any condition or compliance issue which in the opinion of the investigator might
             interfere with participation

        Nonasthmatic control criteria:

        Inclusion Criteria:

          -  Males or females greater than or equal to 12 and less than 70 years of age

          -  Individuals who are in good overall health

          -  Age (within ten years for above 25 years of age and +/- five years for 12-25 years of
             age) and sex matched to the asthmatic group

        Exclusion Criteria:

          -  A subject will be excluded if there is a history within the previous 5 years of:

               -  clinically diagnosed allergy (allergic rhinitis, hay fever or atopic dermatitis),

               -  asthma (beyond 6 years of age),

               -  chronic nasal or sinus disease, or

               -  other chronic lung diseases

          -  Respiratory tract infection within past 4 weeks

          -  History of cigarette smoking within the past 5 years or >10 pack years total

          -  Known allergy to methacholine (for example, a previous bad reaction to methacholine)
             or to any other parasympathomimetic agents

          -  Current use of beta adrenergic blocking agent (a heart medicine) or a cholinesterase
             inhibitor (medicine used to treat myasthenia gravis or Alzheimer's disease).

          -  History of epilepsy, cardiovascular disease with bradycardia (slow heart beat),
             vagotonia (increased activity of the vagus nerve causing slow heart rate or low blood
             pressure), peptic ulcer disease, thyroid disease, or urinary tract obstruction