Clinical Drug Experience Knowledgebase

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