MethaCholine Bronchoprovocation Study (MeCIS) (MeCIS)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00705341 |
Recruitment Status :
Completed
First Posted : June 26, 2008
Results First Posted : February 12, 2013
Last Update Posted : February 12, 2013
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Condition or disease | Intervention/treatment | Phase |
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Asthma | Drug: fluticasone | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 219 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Diagnostic |
Official Title: | MethaCholine Bronchoprovocation - Influence of High Potency Inhaled corticoSteroids in Asthma (MeCIS) Study |
Study Start Date : | January 2009 |
Actual Primary Completion Date : | February 2010 |
Actual Study Completion Date : | February 2010 |
Arm | Intervention/treatment |
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Active Comparator: Low dose fluticasone for phase 2
For people with asthma, fluticasone at 250 mcg per day; phase 2 of study
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Drug: fluticasone
Inhaled corticosteroid approved for treatment of asthma
Other Name: Flovent diskus |
Active Comparator: High dose fluticasone for phase 2
For people with asthma, fluticasone at 1000 mcg per day; phase 2 of study
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Drug: fluticasone
Inhaled corticosteroid approved for treatment of asthma
Other Name: Flovent diskus |
No Intervention: Nonasthmatic controls for phase 1
People without asthma will be enrolled to perform 1 methacholine challenge test in phase 1 of the study
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No Intervention: Asthmatic controls for phase 1
People with asthma will be enrolled to perform 1 methacholine challenge test in phase 1 of the study
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- Methacholine Challenge Test Result for Phase 2 [ Time Frame: weeks 0, 4 ]Presence and degree of airway hyperresponsiveness assessed by methacholine challenge test post-diluent baseline (PC20) after medication holds; PC20 is the methacholine dose at which the amount of air expired in the first second during a forced expiratory maneuver is reduced by 20%; value represents change in baseline to 4 weeks
- Predictive Value of Methacholine Challenge Test for Phase 1 [ Time Frame: one time ]Predictive value of methacholine challenge test in phase 1 for asthmatics and nonasthmatic controls

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 12 Years to 69 Years (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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:
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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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00705341
United States, California | |
University of California at San Diego | |
San Diego, California, United States, 92103 | |
United States, Florida | |
The Nemours Children's Clinic | |
Jacksonville, Florida, United States, 32207 | |
University of Miami/Univestiy of South Florida | |
Miami, Florida, United States, 33136 | |
United States, Illinois | |
Northwestern University Memorial Hospital | |
Chicago, Illinois, United States, 60611 | |
United States, Indiana | |
Indiana University | |
Indianapolis, Indiana, United States, 46202 | |
United States, Louisiana | |
Louisianna State University | |
New Orleans, Louisiana, United States, 70112 | |
United States, Missouri | |
University of Missouri-Kansas City | |
Kansas City, Missouri, United States, 64108 | |
Washington University School of Medicine | |
St. Louis, Missouri, United States, 631110 | |
United States, New York | |
Long Island Jewish Medical Center | |
New Hyde Park, New York, United States, 11040 | |
New York Consortium/Columbia University | |
New York, New York, United States, 10016 | |
New York Medical College | |
Valhalla, New York, United States, 10595 | |
United States, Ohio | |
Ohio State University | |
Columbus, Ohio, United States, 43210 | |
United States, Vermont | |
Vermont Lung Center at the University of Vermont | |
Burlington, Vermont, United States, 05405 |
Principal Investigator: | Kaharu Sumino, MD | St. Louis Asthma Clinical Research Center |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Janet Holbrook, Associate Professor, Johns Hopkins Bloomberg School of Public Health |
ClinicalTrials.gov Identifier: | NCT00705341 |
Other Study ID Numbers: |
ALAACRC07 |
First Posted: | June 26, 2008 Key Record Dates |
Results First Posted: | February 12, 2013 |
Last Update Posted: | February 12, 2013 |
Last Verified: | February 2013 |
Normal Controls |
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Fluticasone |
Anti-Inflammatory Agents Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Asthmatic Agents Respiratory System Agents Dermatologic Agents Anti-Allergic Agents |