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Therapeutic Areas: Pulmonary/Respiratory Diseases | Trauma (Emergency, Injury, Surgery) | Immunology | Family Medicine
Disease Category: COPD (Chronic Obstructive Pulmonary Disease)
Location: United States, FL

Clinical Trial Details

Overview

Research Study Summary

Have you been diagnosed with COPD? We are seeking participants who are currently taking Advair or Symbicort on a daily basis to evaluate an investigational medication for COPD

Purpose

We are currently participating in a study to demonstrate the additional benefit of a FDA Approved Oral Medication when added on to fixed-dose combination of Advair or Symbicort in the reduction of exacerbations in subjects with severe to very severe COPD

Patient Inclusion Criteria:

  • Male or female subjects at least 40 years of age
  • History of COPD for at least 12 months associated with chronic productive cough for 3 months in each of 2 consecutive years .
  • At least two documented moderate or severe COPD exacerbations treated with antibiotics or systemic glucocorticosteroids within 12 months prior to Screening
  • Former smoker (defined as smoking cessation at least 1 year ago) or current smoker both with a smoking history of at least 20 pack-years
  • Subjects must be on (Advair® 250/50µg 1 puff BID or, Symbicort® 160/4.5 µg 2 puffs BID concomitant treatment ≥ 3 months prior to Screening (Visit 1)

Patient Exclusion Criteria:

  • COPD exacerbation and/or COPD exacerbations treated with antibiotics or systemic glucocorticosteroids within 4 weeks of
  • Known alpha-1-antitrypsin deficiency
  • Current diagnosis of asthma (either controlled or uncontrolled)
  • Body mass index (BMI) ≥ 45
Participants will receive study-related care and medications at no cost. Compensation may be available for time and travel

To Learn more
Gender

Both Male and Female

Age

40 and up

Overall Status

Recruiting

Facility Type

N/A

Contact

Luis A. Sanchez, Study Coordinator
Central Medical Group, P.A Research
6610 N. University Drive
Suite 120
Tamarac, FL 33321
Phone: 954-720-7211

View Map

Research Center Information: Central Medical Group, P.A Research

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: 180207

Date Last Changed: July 19, 2013


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