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Therapeutic Areas: Pulmonary/Respiratory Diseases | Family Medicine
Disease Category: Asthma
Location: United States, FL

Clinical Trial Details

Overview

Research Study Summary

Do you, or does your child have asthma?

Purpose

This study is a randomized, double-blind, stratified, parallel-group, multicenter study, 26 weeks in duration, that is designed to evaluate the non-inferiority of fluticasone propionate/salmeterol combination versus fluticasone propionate on the composite endpoint of serious asthma outcomes (asthma-related hospitalization, endotracheal intubation, and death) in subjects with asthma. There is no placebo in this clinical research study. There will be no blood draws. Qualified study participants will receive asthma medication and study related medical care for their asthma at no charge. Compensation may be provided for time and travel.

Patient Inclusion Criteria:

  • Are 12 years of age or older, have had asthma for at least one year, are receiving asthma treatment, have had asthma bad enough to see a doctor in the last 12 months.

Patient Exclusion Criteria:

  • Subject has unstable asthma within 7 days prior to Visit 1, Subject has an acute upper or lower respiratory tract infection at Visit 1, Subject has concurrent chronic respiratory disease, including but not limited to chronic bronchitis, COPD, or emphysema, Subject had greater than 2 hospitalizations for asthma in the 12 months prior to Visit 1, Subject had an asthma exacerbation requiring systemic corticosteroids within 4 weeks of Visit 1 OR more than 4 separate asthma exacerbations in the 12 months prior to Visit 1, Tobacco Use: History of smoking greater than 10 pack-years

To Learn more
Phase

3

Gender

Both Male and Female

Age

12 and up

Overall Status

Recruiting

Duration

26 Weeks

Facility Type

N/A

Contact

Jeffrey Hirschfield, M.D., Principal Investigator
SCORE Physician Alliance
6499 38Th Avenue North, Suite A-2
St. Petersburg, FL 33710
Phone: 727-381-4305

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Research Center Information: SCORE Physician Alliance

If you would like to learn more about participating in this research study, please email the trial contact using the form below.

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CW ID: 182056

Date Last Changed: July 18, 2013


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