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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

A 24 week study for patients who suffer from Chronic Obstructive Pulmonary Disease (COPD) due to current or prior history of smoking. Study Medication, Medical Care, Compensation may be provided to patients who qualify.

Purpose

This study is to evaluate the effect of (GW685698)/Vilanterol (GW642444) inhalation powder delivered once daily via Novel Dry Powder Inhaler for Arterial Stiffness (hardening of the arteries) compared with placebo and Vilanterol in patients who suffer from chronic obstructive pulmonary disease (COPD)

Patient Inclusion Criteria:

  • Informed consent: Subjects must give their signed and dated written informed consent to participate.
  • Age: greater than or equal to 40 years of age at Screening (Visit 1)
  • COPD diagnosis: Subjects with a clinical history of COPD in accordance with the following definition by the American Thoracic Society (ATS) / European Respiratory Society (ERS).
  • Subjects with a current or prior history of greater than or equal to 10 pack-years of cigarette smoking at Screening (Visit 1).
  • Subjects with a measured post-albuterol/salbutamol FEV1 less than 70% of predicted at Screening (Visit 1).
  • Subjects with a measured post-albuterol/salbutamol FEV1/FVC ratio of less than or equal to 0.70 at Screening (Visit 1).
  • Baseline aPWV: subjects with a measured aPWV greater than 12.0 m/s at Screening (Visit 1).

Patient Exclusion Criteria:

  • Body Mass Index of less than or equal to 35
  • Lung Resection within 12 months prior to screen or having had a lung transplantation
  • Current or severe heart failure
  • Oxygen use more than 12 hrs/daily
  • Lower Respiratory Tract Infection that required antibiotic use within 6 months prior to V1
  • Complete right or left bundle branch block

To Learn more
Phase

3

Gender

Both Male and Female

Age

40 and up

Overall Status

Recruiting

Duration

24 Weeks

Facility Type

N/A

Contact

Angel I. Ribo, PA-C, MPAS, AAHIVS, President/CEO
Peninsula Research
305 Clyde Morris Blvd, Suite 250.
Ormond Beach, FL 32174
Phone: 386-677-0525

View Map

Research Center Information: Peninsula 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: 182200

Date Last Changed: March 11, 2014


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