Repeated High-dose Inhaled Corticosteroids for Asthma (ReHICS)

• ClinicalTrials.gov Identifier: NCT00695604
• Recruitment Status: Withdrawn
• First Posted: June 12, 2008
• Last Update Posted: May 8, 2018
• Sponsor: University of Chicago
• Information provided by (Responsible Party): University of Chicago

Tracking Information

• First Submitted Date: June 10, 2008
• First Posted Date: June 12, 2008
• Last Update Posted Date: May 8, 2018
• Actual Study Start Date: May 2008
• Actual Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: December 22, 2008): Airflow inflammation. [ Time Frame: Pre-study and post-study drug administration ]
• Original Primary Outcome Measures (submitted: June 11, 2008): Repeated high-dose inhaled corticosteroids will improve airflow inflammation. [ Time Frame: 1 day ]
• Current Secondary Outcome Measures (submitted: December 22, 2008): Airflow obstruction. [ Time Frame: Pre-study and post-study drug administration ]
• Original Secondary Outcome Measures (submitted: June 11, 2008): Repeated high-dose inhaled corticosteroids will improve airflow obstruction. [ Time Frame: 1 day ]
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Repeated High-dose Inhaled Corticosteroids for Asthma
• Official Title: Repeated High-dose Inhaled Corticosteroids for Asthma
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Treatment
• Condition: Asthma

Intervention

• Drug: Placebo
  Placebo via MDI.
• Drug: Fluticasone
  Fluticasone MDI.

Study Arms

• Placebo Comparator: 1

  Placebo Comparator

  All patients assigned to this group will receive:

  1. Placebo via Metered Dose Inhaler (MDI).
  2. Albuterol via MDI.
  Intervention: Drug: Placebo
• Active Comparator: 2

  Active Comparator

  All patients assigned to this group will receive:

  1. Fluticasone via MDI.
  2. Albuterol via MDI.
  Intervention: Drug: Fluticasone

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Withdrawn
• Actual Enrollment (submitted: May 12, 2017): 0
• Original Estimated Enrollment (submitted: June 11, 2008): 20
• Actual Study Completion Date: September 2011
• Actual Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 50 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00695604
• Other Study ID Numbers: 15322B
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: University of Chicago
• Study Sponsor: University of Chicago
• Collaborators: Not Provided

Investigators

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

• PRS Account: University of Chicago
• Verification Date: May 2018