MethaCholine Bronchoprovocation Study (MeCIS)

This study has been completed.
Sponsor:
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
New York University School of Medicine
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
ClinicalTrials.gov Identifier:
NCT00705341
First received: June 24, 2008
Last updated: February 11, 2013
Last verified: February 2013
  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. 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 Intervention Phase
Asthma
Drug: fluticasone
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: MethaCholine Bronchoprovocation - Influence of High Potency Inhaled corticoSteroids in Asthma (MeCIS) Study

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Methacholine Challenge Test Result for Phase 2 [ Time Frame: weeks 0, 4 ] [ Designated as safety issue: No ]
    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 [ Time Frame: one time ] [ Designated as safety issue: No ]
    Predictive value of methacholine challenge test in phase 1 for asthmatics and nonasthmatic controls


Enrollment: 219
Study Start Date: January 2009
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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:   12 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 (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
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, see Learn About Clinical Studies.

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

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
New York University School of Medicine
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:
No publications provided by Johns Hopkins Bloomberg School of Public Health

Additional 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     History of Changes
Other Study ID Numbers: ALAACRC07
Study First Received: June 24, 2008
Results First Received: August 1, 2012
Last Updated: February 11, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by 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
Methacholine Chloride
Fluticasone
Miotics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Parasympathomimetics
Bronchoconstrictor Agents
Respiratory System Agents
Therapeutic Uses
Muscarinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Bronchodilator Agents
Anti-Asthmatic Agents
Dermatologic Agents
Anti-Allergic Agents

ClinicalTrials.gov processed this record on August 21, 2014