MethaCholine Bronchoprovocation Study (MeCIS)

This study is not yet open for participant recruitment.

Verified by Johns Hopkins Bloomberg School of Public Health, June 2008

Sponsors and Collaborators:	Johns Hopkins Bloomberg School of Public Health University of Alabama at Birmingham University of Minnesota Washington University School of Medicine St. Louis University Long Island Jewish Medical Center North Shore University Hospital Baylor College of Medicine University of Vermont Nemours Children's Clinic University of Florida Indiana University Ohio State University University of Pennsylvania New York University School of Medicine University of Missouri-Columbia Northwestern University Louisiana State University Emory University University of Miami University of South Florida University of California, San Diego National Jewish Health Duke University
Information provided by:	Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier:	NCT00705341

Purpose

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

Condition	Intervention	Phase
Asthma	Drug: fluticasone diskus	Phase IV

MedlinePlus related topics: Asthma

Drug Information available for: Corticosteroids Fluticasone Fluticasone propionate Methacholine Methacholine chloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Crossover Assignment, Efficacy Study
Official Title:	MethaCholine Bronchoprovocation - Influence of High Potency Inhaled corticoSteroids in Asthma (MeCIS) Study

Further study details as provided by Johns Hopkins Bloomberg School of Public Health:

Primary Outcome Measures:

Methacholine challenge test result - PC20 [ Time Frame: weeks 0, 4, 8, 12, 16 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Asthma Control Score [ Time Frame: weeks 0, 4, 8, 12 16 ] [ Designated as safety issue: No ]
Spirometry (lung function) test results [ Time Frame: weeks 0, 4, 8, 12, 16 ] [ Designated as safety issue: No ]

Estimated Enrollment:	140
Study Start Date:	August 2008
Estimated Study Completion Date:	August 2009
Estimated Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Low dose: Active Comparator For people with asthma, fluticasone at 250 mcg per day	Drug: fluticasone diskus Inhaled corticosteroid approved for treatment of asthma
High dose: Active Comparator For people with asthma, fluticasone at 1000 mcg per day	Drug: fluticasone diskus Inhaled corticosteroid approved for treatment of asthma
Controls: No Intervention 70 people without asthma will be enrolled to perform 1 methacholine challenge test in phase 1 of the study

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 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.

Eligibility

Ages Eligible for Study:	6 Years to 69 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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 (ED visit, hospitalization, course of increased systemic steroids, or urgent health care visit for asthma) during the prior four weeks
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 in the study Healthy control participants

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 yrs for above 25 yrs of age and +/- five yrs for 12-25 yrs 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 yrs of:
- clinically diagnosed allergy (allergic rhinitis, hay fever or atopic dermatitis),
- asthma (beyond 6 yrs 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00705341

Contacts

Contact: Charlene Levine	410-614-6022	clevine@jhsph.edu
Contact: Ellen Brown, MS	410-955-3118	ellbrown@jhsph.edu

Locations

United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 631110
United States, Vermont
Vermont Lung Center at the University of Vermont
Burlington, Vermont, United States, 05405

Sponsors and Collaborators

Johns Hopkins Bloomberg School of Public Health

University of Alabama at Birmingham

University of Minnesota

Washington University School of Medicine

St. Louis University

Long Island Jewish Medical Center

North Shore University Hospital

Baylor College of Medicine

University of Vermont

Nemours Children's Clinic

University of Florida

Indiana University

Ohio State University

University of Pennsylvania

New York University School of Medicine

University of Missouri-Columbia

Northwestern University

Louisiana State University

Emory University

University of Miami

University of South Florida

University of California, San Diego

National Jewish Health

Duke University

More Information

Asthma Clinical Research Centers website This link exits the ClinicalTrials.gov site

Responsible Party:	Johns Hopkins School of Public Health ( Robert A. Wise, Professor of Medicine )
Study ID Numbers:	ALAACRC07
Study First Received:	June 24, 2008
Last Updated:	August 4, 2008
ClinicalTrials.gov Identifier:	NCT00705341
Health Authority:	United States: Institutional Review Board

Keywords provided by Johns Hopkins Bloomberg School of Public Health:

Normal Controls

Study placed in the following topic categories:

Hypersensitivity
Lung Diseases, Obstructive
Respiratory Tract Diseases
Lung Diseases
Methacholine Chloride

Hypersensitivity, Immediate
Fluticasone
Asthma
Respiratory Hypersensitivity

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Parasympathomimetics
Respiratory System Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Bronchial Diseases
Immune System Diseases
Cholinergic Agonists
Bronchoconstrictor Agents
Miotics
Physiological Effects of Drugs

Anti-Asthmatic Agents
Anti-Allergic Agents
Cholinergic Agents
Pharmacologic Actions
Autonomic Agents
Therapeutic Uses
Muscarinic Agonists
Peripheral Nervous System Agents
Dermatologic Agents
Bronchodilator Agents

ClinicalTrials.gov processed this record on January 16, 2009