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NCT00695604 Clinical Trial

Repeated High-dose Inhaled Corticosteroids for Asthma

Asthma Clinical Trial

— ReHICS  

Official title:
Repeated High-dose Inhaled Corticosteroids for Asthma

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT00695604
Other study ID # 15322B
Secondary ID
Status Withdrawn
Phase Phase 2
First received
Last updated
Start date May 2008
Est. completion date September 2011

Study information
Verified date May 2018
Source University of Chicago
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date September 2011
Est. primary completion date September 2011
Accepts healthy volunteers No
Gender All
Age group 18 Years to 50 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
United States The University of Chicago Chicago Illinois

Sponsors (1)
Lead Sponsor Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Airflow inflammation. Pre-study and post-study drug administration
Secondary Airflow obstruction. Pre-study and post-study drug administration
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