Status:
COMPLETED
MethaCholine Bronchoprovocation Study (MeCIS)
Lead Sponsor:
Johns Hopkins Bloomberg School of Public Health
Collaborating Sponsors:
Washington University School of Medicine
St. Louis University
Conditions:
Asthma
Eligibility:
All Genders
12-69 years
Phase:
PHASE4
Brief 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 ch...
Detailed 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 par...
Eligibility Criteria
Inclusion
- Asthmatic participants
- 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
- 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
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
219 Patients enrolled
Trial Details
Trial ID
NCT00705341
Start Date
January 1 2009
End Date
February 1 2010
Last Update
February 12 2013
Active Locations (13)
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1
University of California at San Diego
San Diego, California, United States, 92103
2
The Nemours Children's Clinic
Jacksonville, Florida, United States, 32207
3
University of Miami/Univestiy of South Florida
Miami, Florida, United States, 33136
4
Northwestern University Memorial Hospital
Chicago, Illinois, United States, 60611