Status and phase
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About
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.
Full description
The study consists of two phases. The first phase is a cross-sectional, case-control study measuring the sensitivity and specificity of methacholine challenge testing for differentiating asthmatic participants from non-asthmatic controls. The second phase is a cross-over, randomized, double-masked trial designed to evaluate the impact of high dose versus low dose inhaled corticosteroids (ICS) on bronchial hyperreactivity (BHR) in asthmatics.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
Asthmatic participants
Inclusion Criteria:
Exclusion Criteria:
Nonasthmatic control criteria:
Inclusion Criteria:
Exclusion Criteria:
A subject will be excluded if there is a history within the previous 5 years of:
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
Primary purpose
Allocation
Interventional model
Masking
219 participants in 4 patient groups
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Data sourced from clinicaltrials.gov
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