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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
History of Changes
Results First Received: August 1, 2012  
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
Condition: Asthma
Intervention: Drug: fluticasone

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Asthmatic Controls for Phase 1 People with asthma perform 1 methacholine challenge test in phase 1 to measure the sensitivity and specificity of methacholine challenge testing. Participants did not receive an intervention in phase 1.
Non Asthmatic Controls for Phase 1 People without asthma perform 1 methacholine challenge test in phase 1 to measure the sensitivity and specificity of methacholine challenge testing. Participants did not receive an intervention in phase 1.
Low Dose, Then High Dose Fluticasone for Phase 2 People with asthma receive fluticasone at 250 mcg per day (28 days), then wash-out period (28 days), then fluticasone at 1000 mcg per day (28 days) in phase 2.
High Dose, Then Low Dose Fluticasone for Phase 2 People with asthma receive fluticasone at 1000 mcg per day 28 days), then wash-out period (28 days), fluticasone at 250 mcg per day (28 days) in phase 2.

Participant Flow for 2 periods

 Period 1:   Phase 1:Control Challenge
    Asthmatic Controls for Phase 1     Non Asthmatic Controls for Phase 1     Low Dose, Then High Dose Fluticasone for Phase 2     High Dose, Then Low Dose Fluticasone for Phase 2  
STARTED     126     93     0     0  
COMPLETED     126 [1]   93 [2]   0     0  
NOT COMPLETED     0     0     0     0  
[1] If participants in this group met criteria, they were randomized into phase 2
[2] Nonasthmatic controls did not advance to phase 2 due to design of study

Period 2:   Phase 2: Trial
    Asthmatic Controls for Phase 1     Non Asthmatic Controls for Phase 1     Low Dose, Then High Dose Fluticasone for Phase 2     High Dose, Then Low Dose Fluticasone for Phase 2  
STARTED     0     0     30 [1]   32 [1]
COMPLETED     0     0     23     28  
NOT COMPLETED     0     0     7     4  
Withdrawal by Subject                 0                 0                 6                 4  
Did not meet post-diluent threshold                 0                 0                 1                 0  
[1] This group was randomized from asthmatic controls in phase 1 if they met criteria to be in phase 2



  Baseline Characteristics
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Reporting Groups
  Description
Nonasthmatic Controls for Phase 1 People without asthma perform 1 methacholine challenge test in phase 1 to measure the sensitivity and specificity of methacholine challenge testing. Participants did not receive an intervention in phase 1.
Asthmatic Controls for Phase 1 People with asthma perform 1 methacholine challenge test in phase 1 to measure the sensitivity and specificity of methacholine challenge testing. Participants did not receive an intervention in phase 1.
Total Total of all reporting groups

Baseline Measures
    Nonasthmatic Controls for Phase 1     Asthmatic Controls for Phase 1     Total  
Number of Participants  
[units: participants]
 		  93     126     219  
Age  
[units: participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     93     126     219  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation 		  33  ± 13     38  ± 15     35  ± 14  
Gender  
[units: participants]
 		     
Female     56     84     140  
Male     37     42     79  
Region of Enrollment  
[units: participants]
 		     
United States     93     126     219  



  Outcome Measures
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1.  Primary:   Methacholine Challenge Test Result for Phase 2   [ Time Frame: weeks 0, 4 ]
  Show Outcome Measure 1

2.  Secondary:   Predictive Value of Methacholine Challenge Test for Phase 1   [ Time Frame: one time ]
  Show Outcome Measure 2


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:  
Name/Title: Anne Capser
Organization: Johns Hopkins University
phone: 410-955-8183
e-mail: ashankli@jhsph.edu


No publications provided by Johns Hopkins Bloomberg School of Public Health

Publications automatically indexed to this study:


Responsible Party: Janet Holbrook, 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