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Repeated High-dose Inhaled Corticosteroids for Asthma (ReHICS)

This study has been withdrawn prior to enrollment.
(Study was not able to be completed, no results analyzed.)
Information provided by (Responsible Party):
Jerry A. Krishnan, University of Illinois at Chicago Identifier:
First received: June 10, 2008
Last updated: May 12, 2017
Last verified: May 2017
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 Intervention Phase
Drug: Placebo
Drug: Fluticasone
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator
Primary Purpose: Treatment
Official Title: Repeated High-dose Inhaled Corticosteroids for Asthma

Resource links provided by NLM:

Further study details as provided by Jerry A. Krishnan, University of Illinois at Chicago:

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

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

Enrollment: 0
Actual Study Start Date: May 2008
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00695604

United States, Illinois
The University of Chicago
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
Johns Hopkins University
Principal Investigator: Jerry Krishnan, MD, PhD University of Illinois at Chicago
  More Information

Responsible Party: Jerry A. Krishnan, Professor, University of Illinois at Chicago Identifier: NCT00695604     History of Changes
Other Study ID Numbers: 15322B
Study First Received: June 10, 2008
Last Updated: May 12, 2017

Keywords provided by Jerry A. Krishnan, University of Illinois at Chicago:
Acute asthma
inhaled corticosteroids

Additional relevant MeSH terms:
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 processed this record on May 25, 2017