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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This study has been withdrawn prior to enrollment.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.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00695604
First Posted: June 12, 2008
Last Update Posted: July 28, 2017
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.
Information provided by (Responsible Party):
University of Chicago
  Purpose
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
Asthma Drug: Placebo Drug: Fluticasone Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (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 University of 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.

  Eligibility

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.


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

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
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 ClinicalTrials.gov identifier (NCT number): NCT00695604


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

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT00695604     History of Changes
Other Study ID Numbers: 15322B
First Submitted: June 10, 2008
First Posted: June 12, 2008
Last Update Posted: July 28, 2017
Last Verified: July 2017

Keywords provided by University of Chicago:
Acute asthma
fluticasone
inhaled corticosteroids

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Fluticasone
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