MethaCholine Bronchoprovocation Study (MeCIS) (MeCIS)

• ClinicalTrials.gov Identifier: NCT00705341
• Recruitment Status: Completed
• First Posted: June 26, 2008
• Results First Posted: February 12, 2013
• Last Update Posted: February 12, 2013
• Sponsor: Johns Hopkins Bloomberg School of Public Health
• Collaborators: 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; NYU Langone Health; University of Missouri-Columbia; Northwestern University; Louisiana State University Health Sciences Center in New Orleans; University of Miami; University of South Florida; University of California, San Diego; National Jewish Health; Duke University
• Information provided by (Responsible Party): Janet Holbrook, Johns Hopkins Bloomberg School of Public Health

Study Description

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 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.

Condition or disease	Intervention/treatment	Phase
Asthma	Drug: fluticasone	Phase 4

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.

Study Design

• 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

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Low dose fluticasone for phase 2; For people with asthma, fluticasone at 250 mcg per day; phase 2 of study	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	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
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

Outcome Measures

Primary Outcome Measures :

1. 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

Secondary Outcome Measures :

1. 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

Eligibility Criteria

• Ages Eligible for Study: 12 Years to 69 Years (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• 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 (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

Contacts and Locations

Locations

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

Sponsors and Collaborators

Johns Hopkins Bloomberg School of Public Health

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

NYU Langone Health

University of Missouri-Columbia

Northwestern University

Louisiana State University Health Sciences Center in New Orleans

University of Miami

University of South Florida

University of California, San Diego

National Jewish Health

Duke University

Investigators

• Principal Investigator: Kaharu Sumino, MD; St. Louis Asthma Clinical Research Center

More Information

Additional Information:

Asthma Clinical Research Centers website 

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Sumino K, Sugar EA, Irvin CG, Kaminsky DA, Shade D, Wei CY, Holbrook JT, Wise RA, Castro M; American Lung Association Asthma Clinical Research Centers. Methacholine challenge test: diagnostic characteristics in asthmatic patients receiving controller medications. J Allergy Clin Immunol. 2012 Jul;130(1):69-75.e6. doi: 10.1016/j.jaci.2012.02.025. Epub 2012 Apr 1. Erratum in: J Allergy Clin Immunol. 2012 Nov;130(5):1084.

• 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
• Results First Posted: February 12, 2013
• Last Update Posted: February 12, 2013
• Last Verified: February 2013

Keywords provided by Janet Holbrook, Johns Hopkins Bloomberg School of Public Health:

Normal Controls

Additional relevant MeSH terms:

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