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Principal Name   Daniel Doyle, MD
Contact Name   Tammy Bator, LPN, CCRC
Phone   (413) 395-7910
Fax   (413) 346-6708
Title   A study to Evaluate the effect of Roflumilast(Daliresp), on the exacerbation rate in patients with COPD
Description   Roflumilast is a new drug currently marketed (approved by the U.S. Food and Drug Administration (FDA) for use in humans) in the US and is indicated (used) for treatment of people with severe COPD to treat the symptoms of cough and excess mucous linked to chronic bronchitis. Roflumilast is used to reduce the risk (chance) of COPD exacerbations (increase in symptoms such as cough, mucus secretions, and shortness of breath, that can be life threatening and reduces your ability to breathe) linked to chronic bronchitis (swelling of the airways in the lungs) in people with a history of exacerbations.
The purpose of this study is to investigate how well roflumilast reduces the frequency of exacerbations in people with severe COPD, when used with a combination of two medications at an unchanged dose, known as a long-acting ß2 agonist (LABA) and an inhaled corticosteroid (ICS). There are two LABA/ICS combination medications, fluticasone/salmeterol (Advair®) (at a 250/50 µg dose) and budesonide/formoterol (Symbicort®) (at a 160/4.5 µg dose), used in this study which you may already be familiar with. Both are currently FDA-approved in the U.S. and marketed worldwide (approved by health authorities in many countries for use in humans) for the treatment of COPD. There will also be a placebo (contains no roflumilast or any other active ingredient) used in this study. Some people in this study will get placebo along with Advair® or Symbicort® to compare the effects of roflumilast with Advair® or Symbicort®.
Treatment   Pulmonary
Inclusion/Notes   Male or female patients at least 40 years of age

History of COPD (according to GOLD 2010) for at least 12 months prior Screening (Visit 1) associated with chronic productive cough for 3 months in each of 2 consecutive years (with other causes of productive cough excluded)

At least two documented moderate or severe COPD exacerbations within 12 months
prior to Screening (Visit 1)

Must be able to perform repeatable pulmonary function testing for FEV1

Former smokers (defined as smoking cessation at least 1 year ago) or current smokers
(including patients who ceased smoking within the past year) both with a smoking history of at least 20 pack-years.
Status   Active
Start Date   03/25/2013
Current Trial Type   pulmonary

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