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MethaCholine Bronchoprovocation Study (MeCIS) (MeCIS)

Primary Purpose

Asthma

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
fluticasone
Sponsored by
Johns Hopkins Bloomberg School of Public Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Asthma focused on measuring Normal Controls

Eligibility Criteria

12 Years - 69 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of California at San Diego
  • The Nemours Children's Clinic
  • University of Miami/Univestiy of South Florida
  • Northwestern University Memorial Hospital
  • Indiana University
  • Louisianna State University
  • University of Missouri-Kansas City
  • Washington University School of Medicine
  • Long Island Jewish Medical Center
  • New York Consortium/Columbia University
  • New York Medical College
  • Ohio State University
  • Vermont Lung Center at the University of Vermont

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

No Intervention

No Intervention

Arm Label

Low dose fluticasone for phase 2

High dose fluticasone for phase 2

Nonasthmatic controls for phase 1

Asthmatic controls for phase 1

Arm Description

For people with asthma, fluticasone at 250 mcg per day; phase 2 of study

For people with asthma, fluticasone at 1000 mcg per day; phase 2 of study

People without asthma will be enrolled to perform 1 methacholine challenge test in phase 1 of the study

People with asthma will be enrolled to perform 1 methacholine challenge test in phase 1 of the study

Outcomes

Primary Outcome Measures

Methacholine Challenge Test Result for Phase 2
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

Predictive Value of Methacholine Challenge Test for Phase 1
Predictive value of methacholine challenge test in phase 1 for asthmatics and nonasthmatic controls

Full Information

First Posted
June 24, 2008
Last Updated
February 11, 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
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1. Study Identification

Unique Protocol Identification Number
NCT00705341
Brief Title
MethaCholine Bronchoprovocation Study (MeCIS)
Acronym
MeCIS
Official Title
MethaCholine Bronchoprovocation - Influence of High Potency Inhaled corticoSteroids in Asthma (MeCIS) Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
February 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the 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

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Normal Controls

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
219 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low dose fluticasone for phase 2
Arm Type
Active Comparator
Arm Description
For people with asthma, fluticasone at 250 mcg per day; phase 2 of study
Arm Title
High dose fluticasone for phase 2
Arm Type
Active Comparator
Arm Description
For people with asthma, fluticasone at 1000 mcg per day; phase 2 of study
Arm Title
Nonasthmatic controls for phase 1
Arm Type
No Intervention
Arm Description
People without asthma will be enrolled to perform 1 methacholine challenge test in phase 1 of the study
Arm Title
Asthmatic controls for phase 1
Arm Type
No Intervention
Arm Description
People with asthma will be enrolled to perform 1 methacholine challenge test in phase 1 of the study
Intervention Type
Drug
Intervention Name(s)
fluticasone
Other Intervention Name(s)
Flovent diskus
Intervention Description
Inhaled corticosteroid approved for treatment of asthma
Primary Outcome Measure Information:
Title
Methacholine Challenge Test Result for Phase 2
Description
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
Time Frame
weeks 0, 4
Secondary Outcome Measure Information:
Title
Predictive Value of Methacholine Challenge Test for Phase 1
Description
Predictive value of methacholine challenge test in phase 1 for asthmatics and nonasthmatic controls
Time Frame
one time

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kaharu Sumino, MD
Organizational Affiliation
St. Louis Asthma Clinical Research Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California at San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
The Nemours Children's Clinic
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
University of Miami/Univestiy of South Florida
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Northwestern University Memorial Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Indiana University
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Louisianna State University
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
University of Missouri-Kansas City
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
Facility Name
Washington University School of Medicine
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
631110
Country
United States
Facility Name
Long Island Jewish Medical Center
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11040
Country
United States
Facility Name
New York Consortium/Columbia University
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
New York Medical College
City
Valhalla
State/Province
New York
ZIP/Postal Code
10595
Country
United States
Facility Name
Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Vermont Lung Center at the University of Vermont
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05405
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22465214
Citation
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.
Results Reference
derived
Links:
URL
http://cctrials.org/alaacrc
Description
Asthma Clinical Research Centers website

Learn more about this trial

MethaCholine Bronchoprovocation Study (MeCIS)

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