MethaCholine Bronchoprovocation Study (MeCIS)

Asthma Clinical Trial

— MeCIS  

Official title:

MethaCholine Bronchoprovocation - Influence of High Potency Inhaled corticoSteroids in Asthma (MeCIS) Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00705341
• Other study ID #: ALAACRC07
• Status: Completed
• Phase: Phase 4
• First received: June 24, 2008
• Last updated: February 11, 2013
• Start date: January 2009
• Est. completion date: February 2010

Study information

• Verified date: February 2013
• Source: Johns Hopkins Bloomberg School of Public Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 219
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 12 Years to 69 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• fluticasone
Inhaled corticosteroid approved for treatment of asthma

Locations

Country	Name	City	State
United States	Vermont Lung Center at the University of Vermont	Burlington	Vermont
United States	Northwestern University Memorial Hospital	Chicago	Illinois
United States	Ohio State University	Columbus	Ohio
United States	Indiana University	Indianapolis	Indiana
United States	The Nemours Children's Clinic	Jacksonville	Florida
United States	University of Missouri-Kansas City	Kansas City	Missouri
United States	University of Miami/Univestiy of South Florida	Miami	Florida
United States	Long Island Jewish Medical Center	New Hyde Park	New York
United States	Louisianna State University	New Orleans	Louisiana
United States	New York Consortium/Columbia University	New York	New York
United States	University of California at San Diego	San Diego	California
United States	Washington University School of Medicine	St. Louis	Missouri
United States	New York Medical College	Valhalla	New York

Sponsors (20)

Lead Sponsor

Collaborator

Johns Hopkins Bloomberg School of Public Health

Baylor College of Medicine, Duke University, Indiana University, Long Island Jewish Medical Center, Louisiana State University Health Sciences Center in New Orleans, National Jewish Health, Nemours Children's Clinic, New York University School of Medicine, North Shore University Hospital, Northwestern University, Ohio State University, St. Louis University, University of California, San Diego, University of Florida, University of Miami, University of Missouri-Columbia, University of South Florida, University of Vermont, Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	weeks 0, 4	No
Secondary	Predictive Value of Methacholine Challenge Test for Phase 1	Predictive value of methacholine challenge test in phase 1 for asthmatics and nonasthmatic controls	one time	No

External Links

•   Asthma Clinical Research Centers website