Repeated High-dose Inhaled Corticosteroids for Asthma (ReHICS)
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ClinicalTrials.gov Identifier: NCT00695604 |
Recruitment Status :
Withdrawn
(Study was not able to be completed, no results analyzed.)
First Posted : June 12, 2008
Last Update Posted : May 8, 2018
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Sponsor:
University of Chicago
Information provided by (Responsible Party):
University of Chicago
Tracking Information | ||||
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First Submitted Date ICMJE | June 10, 2008 | |||
First Posted Date ICMJE | June 12, 2008 | |||
Last Update Posted Date | May 8, 2018 | |||
Actual Study Start Date ICMJE | May 2008 | |||
Actual Primary Completion Date | September 2011 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Airflow inflammation. [ Time Frame: Pre-study and post-study drug administration ] | |||
Original Primary Outcome Measures ICMJE |
Repeated high-dose inhaled corticosteroids will improve airflow inflammation. [ Time Frame: 1 day ] | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
Airflow obstruction. [ Time Frame: Pre-study and post-study drug administration ] | |||
Original Secondary Outcome Measures ICMJE |
Repeated high-dose inhaled corticosteroids will improve airflow obstruction. [ Time Frame: 1 day ] | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Repeated High-dose Inhaled Corticosteroids for Asthma | |||
Official Title ICMJE | Repeated High-dose Inhaled Corticosteroids for Asthma | |||
Brief Summary | The purpose of this study is to to compare the effects of high-dose Inhaled Corticosteroids (ICS) vs. placebo in adults with chronic stable asthma. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Care Provider, Investigator) Primary Purpose: Treatment |
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Condition ICMJE | Asthma | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Withdrawn | |||
Actual Enrollment ICMJE |
0 | |||
Original Estimated Enrollment ICMJE |
20 | |||
Actual Study Completion Date ICMJE | September 2011 | |||
Actual Primary Completion Date | September 2011 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion criteria:
Exclusion criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 50 Years (Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00695604 | |||
Other Study ID Numbers ICMJE | 15322B | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | University of Chicago | |||
Study Sponsor ICMJE | University of Chicago | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | University of Chicago | |||
Verification Date | May 2018 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |