Repeated High-dose Inhaled Corticosteroids for Asthma (ReHICS)

May 4, 2018 updated by: University of Chicago
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60637
        • The University of Chicago

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Airflow inflammation.
Time Frame: Pre-study and post-study drug administration
Pre-study and post-study drug administration

Secondary Outcome Measures

Outcome Measure
Time Frame
Airflow obstruction.
Time Frame: Pre-study and post-study drug administration
Pre-study and post-study drug administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Chicago

Investigators

  • Principal Investigator: Jerry Krishnan, MD, PhD, University of Illinois at Chicago

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2008

Primary Completion (Actual)

September 1, 2011

Study Completion (Actual)

September 1, 2011

Study Registration Dates

First Submitted

June 10, 2008

First Submitted That Met QC Criteria

June 11, 2008

First Posted (Estimate)

June 12, 2008

Study Record Updates

Last Update Posted (Actual)

May 8, 2018

Last Update Submitted That Met QC Criteria

May 4, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15322B

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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