Repeated High-dose Inhaled Corticosteroids for Asthma (ReHICS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jerry A. Krishnan, University of Chicago
ClinicalTrials.gov Identifier:
NCT00695604
First received: June 10, 2008
Last updated: May 9, 2013
Last verified: May 2013
  Purpose

The purpose of this study is to to compare the effects of high-dose 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: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Repeated High-dose Inhaled Corticosteroids for Asthma

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Airflow inflammation. [ Time Frame: Pre-study and post-study drug administration ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Airflow obstruction. [ Time Frame: Pre-study and post-study drug administration ] [ Designated as safety issue: No ]

Enrollment: 20
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 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

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00695604

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

No publications provided

Responsible Party: Jerry A. Krishnan, Associate Professor, University of Chicago
ClinicalTrials.gov Identifier: NCT00695604     History of Changes
Other Study ID Numbers: 15322B
Study First Received: June 10, 2008
Last Updated: May 9, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Johns Hopkins University:
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
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Dermatologic Agents
Anti-Allergic Agents
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on July 22, 2014