A6631029 - Chronic Obstructive Pulmonary Disease (COPD).

• Research type

  Research Study

• Full title

  A PHASE II, RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ONCE-DAILY ORALLY ADMINISTERED PH-797804 FOR 12 WEEKS IN ADULTS WITH MODERATE TO SEVERE CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) ON A BACKGROUND OF SALMETEROL XINAFOATE/FLUCTICASONE PROPIONATE COMBINATION.

• IRAS ID

  79162

• Sponsor organisation

  Pfizer Ltd

• Eudract number

  2010-024219-15

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  The purpose of this research study is to learn about the effects and safety of the study drug, PH-797804, in comparison to a tablet looking exactly the same but with no effect (placebo) in patients with Chronic Obstructive Lung Disease (COPD) PH-797904 is a new investigational drug. A new investigational drug is one that is currently not approved for sale in this country.All patients will be treated with a standard treatment of inhaled steroids in combination with a bronchodilator. To relieve any acute or increased symptoms an inhaler containing a fast acting bronchodilator will be used.There will be about 328 people taking part in this study from approximately 16 countries in about 75-100 sitesThe patients will be in this study for approximately 18 weeks, which will include 8 visits to the research site and take study treatment for 12 weeks. Two weeks after the patient has stopped taking the investigational drug they will return to the clinic, just to make sure no unexpected side effects have arose. At the visits the patient will be examined for, among other things, blood pressure, heart rate, and how well the lungs work. The patient will also need to give some blood, which will be analyzed to make sure the patient is doing well.Patients will also be asked to fill in different forms on how the disease is affecting their daily life and also will they be asked to record the intake the medicine and how much fast acting bronchodilator they have used in a dairy.

• REC name

  East Midlands - Derby Research Ethics Committee

• REC reference

  11/EM/0235

• Date of REC Opinion

  19 Aug 2011

• REC opinion

  Further Information Favourable Opinion