NCT00705341

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
219

participants targeted

Target at P50-P75 for phase_4 asthma

Timeline
Completed

Started Jan 2009

Shorter than P25 for phase_4 asthma

Geographic Reach
1 country

13 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 24, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 26, 2008

Completed
6 months until next milestone

Study Start

First participant enrolled

January 1, 2009

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
3 years until next milestone

Results Posted

Study results publicly available

February 12, 2013

Completed
Last Updated

February 12, 2013

Status Verified

February 1, 2013

Enrollment Period

1.1 years

First QC Date

June 24, 2008

Results QC Date

August 1, 2012

Last Update Submit

February 11, 2013

Conditions

Asthma

Keywords

Normal Controls

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Predictive Value of Methacholine Challenge Test for Phase 1

    one time

Study Arms (4)

Low dose fluticasone for phase 2

ACTIVE COMPARATOR

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

Drug: fluticasone

High dose fluticasone for phase 2

ACTIVE COMPARATOR

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

Drug: fluticasone

Nonasthmatic controls for phase 1

NO INTERVENTION

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

Asthmatic controls for phase 1

NO INTERVENTION

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

Interventions

fluticasoneDRUG

Inhaled corticosteroid approved for treatment of asthma

Also known as: Flovent diskus
High dose fluticasone for phase 2Low dose fluticasone for phase 2

Eligibility Criteria

Age12 Years - 69 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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:
  • 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
  • A subject will be excluded if there is a history within the previous 5 years of:
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

University of California at San Diego

San Diego, California, 92103, United States

Location

The Nemours Children's Clinic

Jacksonville, Florida, 32207, United States

Location

University of Miami/Univestiy of South Florida

Miami, Florida, 33136, United States

Location

Northwestern University Memorial Hospital

Chicago, Illinois, 60611, United States

Location

Indiana University

Indianapolis, Indiana, 46202, United States

Location

Louisianna State University

New Orleans, Louisiana, 70112, United States

Location

University of Missouri-Kansas City

Kansas City, Missouri, 64108, United States

Location

Washington University School of Medicine

St Louis, Missouri, 631110, United States

Location

Long Island Jewish Medical Center

New Hyde Park, New York, 11040, United States

Location

New York Consortium/Columbia University

New York, New York, 10016, United States

Location

New York Medical College

Valhalla, New York, 10595, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

Vermont Lung Center at the University of Vermont

Burlington, Vermont, 05405, United States

Location

Related Publications (1)

  • 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.

    PMID: 22465214DERIVED

Related Links

MeSH Terms

Conditions

Asthma

Interventions

Fluticasone

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

AndrostadienesAndrostenesAndrostanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Results Point of Contact

Title
Anne Capser
Organization
Johns Hopkins University
ashankli@jhsph.edu
410-955-8183

Study Officials

  • Kaharu Sumino, MD

    St. Louis Asthma Clinical Research Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 24, 2008

First Posted

June 26, 2008

Study Start

January 1, 2009

Primary Completion

February 1, 2010

Study Completion

February 1, 2010

Last Updated

February 12, 2013

Results First Posted

February 12, 2013

Record last verified: 2013-02

Locations

US(13)