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Repeated High-dose Inhaled Corticosteroids for Asthma (ReHICS)

Primary Purpose

Asthma

Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Placebo
Fluticasone
Sponsored by
University of Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring Acute asthma, fluticasone, inhaled corticosteroids

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The University of Chicago

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

1

2

Arm Description

Placebo Comparator All patients assigned to this group will receive: Placebo via Metered Dose Inhaler (MDI). Albuterol via MDI.

Active Comparator All patients assigned to this group will receive: Fluticasone via MDI. Albuterol via MDI.

Outcomes

Primary Outcome Measures

Airflow inflammation.

Secondary Outcome Measures

Airflow obstruction.

Full Information

First Posted
June 10, 2008
Last Updated
May 4, 2018
Sponsor
University of Chicago
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1. Study Identification

Unique Protocol Identification Number
NCT00695604
Brief Title
Repeated High-dose Inhaled Corticosteroids for Asthma
Acronym
ReHICS
Official Title
Repeated High-dose Inhaled Corticosteroids for Asthma
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Withdrawn
Why Stopped
Study was not able to be completed, no results analyzed.
Study Start Date
May 2008 (Actual)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Acute asthma, fluticasone, inhaled corticosteroids

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Placebo Comparator
Arm Description
Placebo Comparator All patients assigned to this group will receive: Placebo via Metered Dose Inhaler (MDI). Albuterol via MDI.
Arm Title
2
Arm Type
Active Comparator
Arm Description
Active Comparator All patients assigned to this group will receive: Fluticasone via MDI. Albuterol via MDI.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo via MDI.
Intervention Type
Drug
Intervention Name(s)
Fluticasone
Intervention Description
Fluticasone MDI.
Primary Outcome Measure Information:
Title
Airflow inflammation.
Time Frame
Pre-study and post-study drug administration
Secondary Outcome Measure Information:
Title
Airflow obstruction.
Time Frame
Pre-study and post-study drug administration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jerry Krishnan, MD, PhD
Organizational Affiliation
University of Illinois at Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States

12. IPD Sharing Statement

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Repeated High-dose Inhaled Corticosteroids for Asthma

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