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Repeated High-dose Inhaled Corticosteroids for Asthma (ReHICS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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Recruitment Status : Withdrawn (Study was not able to be completed, no results analyzed.)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
Sponsor:
Information provided by (Responsible Party):
University of Chicago

Tracking Information
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
 (submitted: December 22, 2008)
Airflow inflammation. [ Time Frame: Pre-study and post-study drug administration ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 11, 2008)
Repeated high-dose inhaled corticosteroids will improve airflow inflammation. [ Time Frame: 1 day ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 22, 2008)
Airflow obstruction. [ Time Frame: Pre-study and post-study drug administration ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 11, 2008)
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
Condition  ICMJE Asthma
Intervention  ICMJE
  • Drug: Placebo
    Placebo via MDI.
  • Drug: Fluticasone
    Fluticasone MDI.
Study Arms  ICMJE
  • Placebo Comparator: 1

    Placebo Comparator

    All patients assigned to this group will receive:

    1. Placebo via Metered Dose Inhaler (MDI).
    2. Albuterol via MDI.
    Intervention: Drug: Placebo
  • Active Comparator: 2

    Active Comparator

    All patients assigned to this group will receive:

    1. Fluticasone via MDI.
    2. Albuterol via MDI.
    Intervention: Drug: Fluticasone
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: May 12, 2017)
0
Original Estimated Enrollment  ICMJE
 (submitted: June 11, 2008)
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:

  • Physician diagnosis of asthma.
  • Age ≥18 years and ≤50 years
  • Evidence of airflow obstruction as measured by spirometry and flow-volume loop per American Thoracic Society guidelines.
  • Treatment for asthma with:

    • daily inhaled corticosteroids and long-acting beta2-agonists, AND
    • as-needed use of a short-acting beta2-agonist

Exclusion criteria:

  • History of >10 pack-year tobacco use
  • Other pulmonary or cardiac diagnosis that is actively being treated
  • History of adverse events or allergy to fluticasone
  • Systemic corticosteroid therapy within 7 days of study visit
  • Inability to obtain written informed consent
Sex/Gender  ICMJE
Sexes Eligible for Study: All
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
Principal Investigator: Jerry Krishnan, MD, PhD University of Illinois at Chicago
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