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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. 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Recruitment Status : Withdrawn (Study was not able to be completed, no results analyzed.)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
Information provided by (Responsible Party):
University of Chicago

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.

Condition or disease Intervention/treatment Phase
Asthma Drug: Placebo Drug: Fluticasone Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Repeated High-dose Inhaled Corticosteroids for Asthma
Actual Study Start Date : May 2008
Actual Primary Completion Date : September 2011
Actual Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma Steroids

Arm Intervention/treatment
Placebo Comparator: 1

Placebo Comparator

All patients assigned to this group will receive:

  1. Placebo via Metered Dose Inhaler (MDI).
  2. Albuterol via MDI.
Drug: Placebo
Placebo via MDI.

Active Comparator: 2

Active Comparator

All patients assigned to this group will receive:

  1. Fluticasone via MDI.
  2. Albuterol via MDI.
Drug: Fluticasone
Fluticasone MDI.

Primary Outcome Measures :
  1. Airflow inflammation. [ Time Frame: Pre-study and post-study drug administration ]

Secondary Outcome Measures :
  1. Airflow obstruction. [ Time Frame: Pre-study and post-study drug administration ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00695604

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United States, Illinois
The University of Chicago
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
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Principal Investigator: Jerry Krishnan, MD, PhD University of Illinois at Chicago
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Responsible Party: University of Chicago Identifier: NCT00695604    
Other Study ID Numbers: 15322B
First Posted: June 12, 2008    Key Record Dates
Last Update Posted: May 8, 2018
Last Verified: May 2018
Keywords provided by University of Chicago:
Acute asthma
inhaled corticosteroids
Additional relevant MeSH terms:
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Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents